Research Coordinator Clinical Research Resume Sample
Loren Stokes
1812 Crist Drive,
Boston,
MA
+1 (555) 931 4537
Work Experience
Clinical Trials Research Coordinator
01/2017
-
PRESENT
Houston, TX
- Compliance Support & comply w/the Principles of Responsibility (KP Code of Conduct). W/guidance from PI, ensure compliance w/ KPNC IRB Standard Operating Procedures (SOP) & document applications. Adhere to Guideline for Good Clinical Practice (GCP), federal, state, & local regulations, & KP policies & procedures W/supervision, prepare for inspections, audits & monitor visits
- Demonstrate age specific patient care considerations for the population served
- Participate in the development, implementation and monitoring of a pharmaceutical care plan to reach a desired outcome for each patient
- Promote cost-effective guidelines and individualized drug therapy
- Follow written protocols within the Washington State Department of Health regulations Determines appropriate individual therapy
- Minimize or prevent the incidences and severity of adverse drug effects; provide oversight and direction to staff
- Provide drug information and education (written or oral) to patients and other customers
- Maintain confidentiality of records or medical center information at all times
- Ensures accurate and complete compilation of subject data through chart reviews
Clinical Research Coordinator Hoag Inst for Research & Ed
04/2010
-
07/2016
New York, NY
- Independently obtains informed consent for other clinical studies
- Mentors Clinical Research Coordinators in training
- Collect, compile, sort and verify the data’s accuracy or completeness before it is entered
- Assures that all protocol revisions, informed consents, continuing reviews, serious adverse events are submitted to the appropriate IRB of record in a timely manner
- Instructs potential study patients, designated caregiver, physicians, nurse clinicians and other ancillary staff members involved in the care of the patient on aspects of patient's care, available trials, treatments and side effects
- Documents study patient's medical history including but not limited to past medical/surgical treatments, significant medical conditions, and medication history per protocol guidelines
- Performs nursing assessments and monitors study patient's progress during clinical trials; Tracks study patient's response by documenting on toxicity flow sheet, medication flow sheet and nurses' progress notes
- Evaluates and develops study patient education materials and gives study patient and/or designated caregiver instructions on drug administration and other medical information; creates study specific calendars for study patients
Temporary Assistant Clinical Research Coordinator
11/2007
-
02/2010
Houston, TX
- Assist in auditing graduate research assistants’ test administration and scoring as needed
- Submits initial and on-going clinical trial essential documents to Institutional Review Board(s) in conjunction with staff
- Maintains the regulatory binder ensuring essential documents are accurate, complete and current
- Interacts and communicates with Sponsors to ensure that regulatory compliance of all studies is maintained
- Maintains competency in the understanding and application of Good Clinical Practices (GCP) guidelines
- Assists Clinical Research Coordinator by completing study specific activities including, but not limited to visit preparation, vital signs, processing lab samples, and scheduling
- Professional written and verbal communication skills inclusive of medical terminology desired
- Study Maintenance: maintains clinical research data worksheets, shared drive, the departmental Wave website, and clinical research files. Provides ongoing oversight of clinical trial regulatory documents and performs periodic study monitoring for regulatory and ICF compliance
Education
Marymount California University
2002 - 2006
Bachelor's Degree in Science
Professional Skills
- Demonstrated experience managing people with a wide range of educational backgrounds and skills
- Excellent communication (written and verbal) and strong interpersonal skills
- Proven experience collecting, evaluating, and interpreting routine standard lab tests on human subjects, i.e. blood tests, vital signs
- Appropriate verbal, written and interpersonal skills
- Experience taking patient history, evaluating patient problems and providing accurate and complete documentation in patient record
- Experience with shipping clinical samples and complying with shipping standards, conditions, and timelines to maintain integrity of samples and data
- Read and interpret lab results and summarize scientific data. Experience processing and shipping human blood samples for onsite and offsite labs
How to write Research Coordinator Clinical Research Resume
Research Coordinator Clinical Research role is responsible for organizational, database, interpersonal, shipping, finance, training, recruiting, security, contracts, oncology.
To write great resume for research coordinator clinical research job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Research Coordinator Clinical Research Resume
The section contact information is important in your research coordinator clinical research resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Research Coordinator Clinical Research Resume
The section work experience is an essential part of your research coordinator clinical research resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous research coordinator clinical research responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular research coordinator clinical research position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Research Coordinator Clinical Research resume experience can include:
- Manages multiple tasks at same time with good organizational skills
- Experience reviewing and abstracting data from medical records
- Notifies principal investigator of any adverse events and serious adverse events, including evidence of drug toxicity or unexpected side effects
- Experience working with cancer patients, families and medical personnel
- Experience managing multi-site clinical trials
- Experience leading communications with study sponsors and institutional leadership
Education on a Research Coordinator Clinical Research Resume
Make sure to make education a priority on your research coordinator clinical research resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your research coordinator clinical research experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Research Coordinator Clinical Research Resume
When listing skills on your research coordinator clinical research resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical research coordinator clinical research skills:
- Excellent verbal, written & interpersonal skills
- Excellent communication skills to interact with staff, parents and children
- Demonstrated experience reading and interpreting EKGs
- Proven experience with coordinating research efforts between multiple institutions or universities
- Demonstrated experience developing clinical trial research forms for subjects
- Experience using EPIC for clinical care, EPIC for Billing reports related to study required procedures and Velos eResearch
List of Typical Experience For a Research Coordinator Clinical Research Resume
1
Experience For Clinical Trials Research Coordinator Resume
- Responsible for completion of all required documentation according to site works guidelines
- Conducts routine and standardized human subjects, and providing support to the principal investigator
- Plans for study patient's appropriate care under the direction of a physician or advanced practice nurse
- Education of Patients: Educate patients about the study. Be available to answer patient’s questions and assist them when necessary
- Advanced theoretical knowledge of a biological science such as Biology, Microbiology or a related field. Demonstrated knowledge of research methods and the basic science of the respiratory, gastrointestinal and musculoskeletal systems including familiarity with general medical problems and terminology
- Demonstrated experience collecting, evaluating, and interpreting protocol required physiological measurements on human subjects, i.e. laboratory tests, cultures, spirometry, vital signs. Ability to read and interpret results and summarize scientific data
2
Experience For VAD Clinical Research Coordinator Resume
- Demonstrated ability to take patient history, evaluate patient problems and provide complete documentation in patient record while maintaining confidentiality of personally identifiable participant information
- Demonstrated ability to work in a laboratory that collects, processes, stores and assays body fluids. Skill in sterile techniques and using basic laboratory equipment. Experience processing, storing and shipping human blood samples for on-site and off-site labs
- Demonstrated ability to develop and implement an effective patient scheduling/appointment system, and coordinate the flow (or necessary documents and referral services)
- Proven experience and expertise in conducting multiple clinical trials, simultaneously. Proven experience in research protocol start up procedures, marketing, outreach, recruitment, and screening of research subjects
- Demonstrated knowledge and adherence to safe laboratory procedures. Demonstrated experience organizing a research laboratory including maintenance, and Environmental Health and Safety Compliance
- Demonstrated experience with cost accounting as applied to both University and Medical Center functions. Demonstrated knowledge of medical billing and collections guidelines and procedures
- Supports enrolling patients onto clinical trials through recruitment, screening, enrollment and follow up of eligible subjects according to protocol requirements
- Ensures the protection of study patients by verifying informed consent procedures and adhering to protocol requirements/compliance
3
Experience For Clinical Research Coordinator, CRC Resume
- Responsible for working with the principal investigator to meet or exceed study enrollment
- Ensures that adequate and accurate records are maintained for inspecting
- Reviews the study design and inclusion/exclusion criteria with physician and patient
- Ensures the integrity of the data submitted on Case Report Forms or other data collection tools by careful source document review; monitors data for missing or implausible data
- Creates study specific tools for source documentation when not provided by sponsor
- Collects, completes, and enters data into study specific case report forms or electronic data capture systems
- Generates and tracks drug shipments, device shipments, and supplies as needed
- Reports and follows up on serious adverse events as necessary
4
Experience For Clinical Research Coordinator Hoag Inst for Research & Ed Resume
- Ensures timely adherence to protocol requirements
- Ensures timely and accurate data completion
- Maintains accurate and complete records including regulatory documents when applicable, signed informed consent forms, source documentation, drug dispensing logs, device utilization logs, subject logs and study-related communications
- Tracks and reports adverse events, serious adverse events, protocol waivers, deviations, and violations
- Communicates all protocol-related issues to appropriate study personnel or manager
- Attends study specific on site meetings, investigator meetings, conference calls and monthly CRC meetings as required or asked to do so
- Assists in the activities related to clinical research
- Assists in the collection, analysis and review experimental data for publication and presentation
5
Experience For Clinical Research Coordinator, RN Resume
- Maintains source documents and subject files in accordance with Mount Sinai policies & procedures
- Supervise all junior CRC team members and manage workload and performance
- Lead annual evaluation efforts for all junior CRC team members by coordinating team feedback, self-appraisals, and preparing and submitting all required documentation
- Develop and implement regulatory plans for multi-site studies (40-50 sites), appropriately identifying and securing institutional guidance and resources and effectively assigning team members for preparation of regulatory documentation
- Supervise the effort of junior clinical research staff in the drafting, tracking, and maintenance of all regulatory submissions including all documents required for initial study submissions, continuing reviews, modifications, deviations, exceptions, and
- Serve as liaison between external study sites and institutional contracting leadership for the purposes of site budget negotiations, financial disclosures, and subaward agreements
- Serve as lead for post-award communications with study sponsor. Complete all sponsor documentation and reporting requirements
- Adhere and guide staff on all University of Pennsylvania, GCP, and FDA guidelines
- Clinical or laboratory expereince
6
Experience For Oncology Clinical Research Coordinator Days CHI Health Cumc Bergan Mercy Resume
- Serve as a resource to SOM study teams to ensure clinical research operations within SOM are compliant with institutional policy as well as IRB regulations, FDA guidelines, ICH Good Clinical Practice and HIPAA regulations
- Participate in the development of best practice guidance and work aids for study teams in areas such as: coverage analysis, pre-award finance, study activation, study coordination, data management, and records management
- Participate with team in evaluating clinical research operations and making recommendations in areas such as: need for policy, process improvement, training, reporting
- Coordinating clinical research, preferably oncology trials
- Serve as a designee of the Principal Investigator, CRS Study Support Services team and the NCI’s National Clinical Trial Network (NCTN) Program to manage the daily operations of assigned research studies in accordance with regulatory, GCP guidelines and institutional policy as well NCTN guidelines
- Develop and maintain patient tracking tools; communicate status to investigators, management and relevant departments
7
Experience For Qualitative Clinical Research Coordinator Resume
- Coordinating clinical research, preferably oncology trials
- Collaborate with clinical research teams to ensure all clinical procedures and other protocol specific activities are completed as per study expectation
- Mentor and train new staff on best clinical research practices
- Participate and initiate new process improvement projects to increase efficiency and compliance for the program
- Study and site management. Participate in sponsor-required training. Obtain information for or coordinate operational plans for multiple research studies. Develop protocol-specific systems and documents including process flows, training manuals, SOPs, and CRFs
- Manages study start-up activities; oversee daily operations of research projects; consenting of participants; management of participants under the study protocols; and study closures
- Oversees the development of controlled clinical trial protocols; participates in the development of the overall clinical plan, drafts protocols, collaborates on statistical analysis plans, and coordinates the protocol review and approval process, to include submissions to regulatory agencies and VA
8
Experience For Rn-clinical Research Coordinator Resume
- Coordinates and creates a plan for the development and implementation of study-specific monitoring and reporting procedures, methods, guidelines, and tools; participates in the establishment of baseline parameters and edit check specifications, and in the development of subject tracking systems
- Ensures appropriate transmission of clinical case data to the data management centers; reviews and addresses case report queries and problems, and clarifies and/or obtains changes to data as appropriate
- Completes, reviews, and maintains case report forms, source documents and regulatory binders for accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and initiates corrective action as required
- Responsible for identifying and reporting any problems and/or issues in order to ensure all clinical aspects of studies are being carried out in accordance with state and federal regulations, guideline and policies
- Supervises and trains research staff in the various research job functions (assessment, recruitment, study protocol, GCP, Local IRB, HRPP, R&D, etc.)
- Monitors study participants while participants are on treatment phase of each protocol to ensure patient safety and adherence to study
9
Experience For Clinical Research Coordinator, Ophthalmology Resume
- Gathers lab tests results, CT/MRI/bone scan/x-ray results, pathology/operative reports, discharge summaries, physicians notes, and outside medical records in order to extract patient data and record data in approved format for study purposes (e.g. case report forms, data summaries)
- Initiates follow-up requests for data as necessary and assures comprehensiveness of individual participants data records
- Accesses, codes and reports toxicities/adverse events/protocol deviations to M.D., Clinical Trials Office (CTO), and Human Research Protection Program (HRPP) and ensures that toxicities are addressed and prevented through protocol-sanctioned dose modifications
- Independently researches and provides input on the development of new research protocols within the Division
- Under direction of Principal Investigator or responsible clinic, differentiates between adverse reactions directly related to investigational drugs and/or treatment as opposed to those unrelated to therapy under evaluation
- Establishes written protocols for all research activities for the research projects. Reviews documents, reports, and/or applications for omissions and inconsistencies
10
Experience For Clinical / Tran Research Coordinator Resume
- Exceptional organizational skills, attention to detail, a strong work ethic, and experience administratively managing clinical trial contracts
- Six mos. or more experience
- Maintains program-specific data to track project milestones, progress reports, funding accomplishments, compliance strategies, etc
- Express thoughts in a clear, concise, and professional manner both verbally and in writing
- Works closely with research participants to ensure the trial meets all regulatory requirements
List of Typical Skills For a Research Coordinator Clinical Research Resume
1
Skills For Clinical Trials Research Coordinator Resume
- Experience: 2 years of clinical research
- Working knowledge of MS office suite, Internet Explorer, Google Chrome
- Accurate, detail oriented; handles multiple tasks
- Scientific concepts and research design. Understand and train others in the basic concepts of study design. Independently conduct literature reviews. Assist with the development of, or develop, proposals or protocols; identify shortcomings of proposals and protocols
- Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds
- Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more
- Utilizes knowledge and expertise to determine patient eligibility into specific clinical trials. Responsible for study subject recruitment and enrollment of appropriate patients
2
Skills For VAD Clinical Research Coordinator Resume
- Plans, facilitates, and implements educational opportunities for patients and their families as it relates to the study conduct, study medication and study-related procedures
- Study procedure scheduling and adherence to protocol timelines. Collaborate with the institution’s ancillary staff and departments to promote the proper study conduct. Handles specimens for collection and shipment to central laboratories
- Corresponds with sponsors on ideal resolution from study audit findings. Makes recommendations on process improvement and impacts on departments standard operating procedures
- Primary responsibilities are to provide data management in a timely manner for patients on cancer trials including facilitating patient entry into programs and managing and collecting data for submission to research centers
- Master’s in Public Health or related clinical field
- Broad knowledge of clinical or laboratory research and clinical research philosophy. Demonstrated ability to translate clinical research philosophy into business best practices in a trial setting
- Skills to work collaboratively with other cross-functional teams. Ability to interface and collaborate with other members of an extended study team. Ability to influence / persuade. Proven ability to effectively coordinate and integrate programs with others in division, department, and organization
- Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator. Ability to influence and negotiate
- Excellent interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship. Interpersonal skills to effectively motivate others. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of administration
3
Skills For Clinical Research Coordinator, CRC Resume
- Demonstrated project management skills. Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities
- Demonstrates good problem-solving and analytical skills. Creatively addresses complex or new problems
- Highly proficient with various computer systems, and computer programs including Filemaker, REDCap, DicomCleaner and MS Office (Excel, Word, Outlook, PowerPoint, etc.), and internet browser applications. Superb database management skills
- Computer literacy strongly recommended
- Knowledge of the cystic fibrosis transmembrane conductance regulator (CFTR) genetic mutations related to cystic fibrosis patients
4
Skills For Clinical Research Coordinator Hoag Inst for Research & Ed Resume
- Demonstrated experience with Office Clinical Trial Administration OCTA, Office of Contracts Grants OCGA, electronic Proposal Developments ePD, electronic Material Transfer Agreements eMTA, Office of Conflict of Interest COI, and Office of Coverage Analysis Administration OCAA. Budget negotiations and invoicing procedures for study reimbursement
- Knowledge of medical terminology; especially cancer related information
- Abstract data from medical charts and computer for research records
- Problem solve appropriately and work under stringent time deadlines
- Perform all commonly applicable functions in word processing and spreadsheet software. Ability to effectively use campus' clinical information and documentation application programs. Proven ability utilizing clinical trial management systems
- Skills to work collaboratively with other cross-functional teams. Ability to interface and collaborate with other members of an extended study team. Ability to influence / persuade. Proven ability to effectively coordinate and integrate programs with other
- Skills to work collaboratively with other cross-functional teams. Ability to interface and collaborate with other members of an extended study team. Ability to influence / persuade. Proven ability to effectively coordinate and integrate programs with others
5
Skills For Clinical Research Coordinator, RN Resume
- Experience utilizing survey-based software Qualtrics
- Supervisory experience in clinical research
- Experience with complex multi-site regulatory submissions and reliance agreements
- Demonstrated independent initiative and ability to work independently with minimal supervision
- Proficient with Microsoft Office Suite and electronic study tracking systems
- Employment is subject to a criminal background check and pre-employment physical
- Extensive knowledge of human research protection regulations
- Multi-task and be flexible in both task and schedule
6
Skills For Oncology Clinical Research Coordinator Days CHI Health Cumc Bergan Mercy Resume
- Proven experience conducting clinical trials. Experience in research protocol start up procedures, marketing, outreach, recruitment, and screening of research subjects
- Organizational skills with ability to prioritize workload effectively and efficiently to meet firm deadlines in an environment with multiple interruptions and changing priorities while exercising independent judgement, showing initiative and resourcefulness when making decisions
- Proven experience developing complex surveys that require skip and other forms of logic while utilizing survey-based software
- Strong knowledge of research methods and protocols and rules of patient confidentiality
- Demonstrated knowledge of FDA and IRB guidelines associated with clinical trials
- IRB/EC management including site application assistance and approval tracking
- Knowledge of the basic science of Gulf War Illness, including familiarity with general medical problems and terminology
- Experience planning, organizing, and managing the scheduling of study visits, sponsor visits or teleconferences, and meetings with key personnel, all in the midst of handling multiple priorities and deadlines
- Strong skill in using Microsoft applications including Word, Excel, PowerPoint, and Outlook, as well as research databases, electronic case report forms, and other computer based programs
7
Skills For Qualitative Clinical Research Coordinator Resume
- Demonstrated experience utilizing survey-based software Qualtrics
- Function independently in a clinical research setting
- Provide time flexibility for scheduling the study visits
- Perform site selection, site initiation, interim monitoring, and site close out visits
- Authorized to have direct communication with the clinical study sites and conduct daily activities supporting the study /project
8
Skills For Rn-clinical Research Coordinator Resume
- Advocate for Patient: Advocate for patient’s well being
- Organize and concurrently manage information in several formats: paper, electronic, and oral
- Experience coordinating clinical trials in a diseased population with multiple health problems. Ability to read scientific text for general understanding of basic concepts
- Summarize and convey technical and medical information to lay individuals at a level appropriate for their understanding
- Proven experience recruiting study subjects. Understanding of medical terminology for screening and recruitment in the context of a clinical trial of investigational agents
9
Skills For Clinical Research Coordinator, Ophthalmology Resume
- Provide data management in a timely manner for patients on cancer trials including facilitating patient entry into programs and managing and collecting data for submission to research centers
- Maintain IRB regulatory material at the local site level. Coordinate adverse event/serious adverse event submissions to the IRB and sponsors. Prepare and assist in any required audits
- Experience in a clinical or scientific related discipline, preferably in oncology
- Clinical or laboratory research experience
- Experience: 5 years of clinical research
10
Skills For Clinical / Tran Research Coordinator Resume
- Clinical research
- Handle multiple, time dependent tasks
- Manage quantitative information and to use computers
- Acquire proficiency in assessment of growth, body composition, and disease characteristics in a timely manner
- Support Clinical teams with oversight of clinical studies
- Clinical project management for multiple multicenter clinical trials
- Data management, preparation of study documents, study protocols, case report forms, study progress reports and clinical site communication
- Write protocols and consent forms, develop case report forms, write study reports for related clinical trials
- Ensure reported trial data is accurate and complete and participate in all clinical data processes, as needed
List of Typical Responsibilities For a Research Coordinator Clinical Research Resume
1
Responsibilities For Clinical Trials Research Coordinator Resume
- Works closely with the project administrator and other research coordinators to ensure all trials in the division are running smoothly, identified issues are addressed, and timelines are met
- Prepares and participates in audits conducted by sponsor/industry, national cooperative group or Clinical Trials Office
- Completes regulatory documents to Research and Development Committee and the Institutional Review Board to initiate new studies, modifications, investigative new drug safety reports, and patient adverse events
- Independently prepares written materials (reports, articles, journal articles, etc.) related to study data
- Confers with project personnel to provide technical advice and to resolve problems. Attends and participates in investigator directed study staff meetings
2
Responsibilities For VAD Clinical Research Coordinator Resume
- Complies with safety and security policies and procedures
- Familiar w/ studies (DOD, NIH'S, DGP, VANPC, VAMC, VHA, etc
- 6 month to 1 year contract with poossbile conversion
- Develop and update Clinical department SOPs
- Quality feedback system clinical representative for communication/complaints
3
Responsibilities For Clinical Research Coordinator, CRC Resume
- Current or prior experience supporting regulatory & clinical strategy, study design & statistical analyses, FDA/regulatory body negotiation, clinical study operations and compliance
- Implements study-specific communications
- Assist the PI in the active recruitment and screening of potential research participants according to the protocol’s inclusion/exclusion criteria. Schedule research participant’s visits in accordance with 1 study protocol. Assist the PI in the training of other site personnel and other medical staff in understanding and implementing the protocol
- Determines participants eligibility for study by requesting, receiving, and recording medical data according to protocol; conducting patient assessment by interviewing and screening patients; and contacting referring physicians and abstracting medical reports. Ensure that all protocol requirements for study entry have been satisfied. Enter participant registration
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