Certified Clinical Research Coordinator Resume Samples

Description :

1. Provided education/information about clinical research protocols to associated health care personnel.
2. Established and maintained a record-keeping system to ensure adequate documentation of each clinical protocol in accordance with FDA requirements.
3. Recruited and enrolled patients who meet the study's inclusion/exclusion criteria.
4. Collected study data and provides patient care according to the protocol.
5. Coordinated and examines varying types of data from multiple sources.
6. Assisted in evaluating patient response to experimental treatment.
7. Observed and recorded the patient's reactions or symptoms in response to treatment.

Experience

7-10 Years

Level

Management

Education

BS in Nursing

Description :

1. Assisted in the organization and preparation of Site Initiation Visits (SIV).
2. Attended investigator meetings as determined by the Research Director.
3. Assisted the PIs in providing the patients and their families with a thorough description of the research protocol.
4. Assured that all protocol revisions, informed consents, continuing reviews, serious adverse events are submitted to the appropriate IRB of record in a timely manner.
5. Compiled patient data and presents those to the PI for their determination of patient eligibility for protocol enrollment.
6. Ensured eligibility forms are completed as required.
7. Assisted the PI in obtaining informed consent and documented the informed consent process as required.

Experience

2-5 Years

Level

Junior

Education

AS In Medical Assisting

Description :

1. Initiated and implemented various sponsored clinical trials.
2. Proactively screened, recruited, and conducted the informed consent process for clinical trials and PI-initiated studies.
3. Ensured clinical trial preparation, by planning, coordinating, training, and assisting the clinical research team throughout all phases of development.
4. Assisted research team in evaluating the standard of care activities vs. non-standard of care activities.
5. Assisted in preparing new protocols and completed interim, annual, and final reports for submission to the institutional review board.
6. Collected research data in accordance with good clinical practice and institutional policies for PI-initiated studies.
7. Prepared for audits, regulatory inspections, sponsor monitoring, closeout visits, or other site visits as appropriate.

Experience

5-7 Years

Level

Executive

Education

BS

Description :

1. Submitted SAE reports and supporting documents.
2. Created Patient Visit Tracking Log to track all patient activity. 
3. Assisted investigators in assessing the value of the study in relation to patient progress.
4. Evaluated methodology and quality of data collected and determined the need for changes in procedures.
5. Assisted with the development of data summaries and presentation materials.
6. Routinely reported the status of patient enrollment and study progress to the investigator, research director, and the sponsor's representative. 
7. Responsible for the facilitation, .

Experience

7-10 Years

Level

Management

Education

BS In Health Education

Description :

1. Coordinated clinical research studies on human subjects.
2. Responsible for regulatory compliance, and the management of all facets of Phase II-IV pediatric clinical research protocols in the department of Psychiatry, and Neurology.
3. Implemented and conducted clinical trials in conjunction with Good Clinical Practice and Food and Drug Agency (FDA) Regulations.
4. Prepared and submitted regulatory documents, patient screening, and recruitment.
5. Informed consent, study enrollment, and participant follow-up.
6. Communicated with sponsors, investigators, and CRA's to ensure effective clinical trial implementation and progress.
7. Collected and documented the patient's vital signs.

Experience

5-7 Years

Level

Executive

Education

BS

Description :

1. Ensured clinical research and related activities performed in accordance with federal regulations and sponsoring agency policies and procedures by coordinating with the principal investigator (PI).
2. Collaborated with PI, preparing and submitting research protocol and consent form for institutional review board (IRB) approval.
3. Prepared study materials such as case report forms (CRF), enrollment logs, and drug accountability logs, tracking sponsor payments.
4. Established and organized study files, regulatory binders, study source documents, and other research-related materials, streamlining efficiency.
5. Assisted PI in conducting the informed consent process, coordinating protocol-required patient tests and procedures.
6. Collected data, assuring timely completion of CRFs while maintaining study timelines.
7. Maintained effective communication with PI, patients, study sponsor, and IRB throughout the study.

Experience

7-10 Years

Level

Management

Education

BS In Nursing

Description :

1. Performed initial client assessment and analysis to begin the research process.
2. Supported Principal and Co-Investigator with daily operational functions.
3. Accompanied the co-investigator on all start-up trial conferences.
4. Communicated daily with monitors, drug representatives, and company liaisons producing excellent trust and trial successes.
5. Obtained documents, clearances, certificates, and approvals from local, state, and federal agencies. 
6. Obtained relevant medical information, explaining treatments and procedures, medications, and adverse events.
7. Worked under specific protocol instruction to perform EKG's, venipunctures, vital signs, urine collection, as well as the processing of the samples.

Experience

10+ Years

Level

Senior

Education

BS

Description :

1. Responsible for all areas of the Clinical Research Department: budget and contract negotiations; IRB Submissions.
2. Attended and participated in Investigator meetings, conferences, and training.
3. Acted as a liaison between physicians, employees, Principal Investigators, and Sub-Investigators.
4. Worked closely with Clinical Research Associates to ensure Investigator binders.
5. Ensured the Research Department is following all regulations and certifications are current.
6. Partnered with Certified Coordinators.
7. Worked with Centricity, Epic, and all other study-specific programs/EDCs needed.

Experience

5-7 Years

Level

Executive

Education

BS

Description :

1. Worked as a primary certified clinical research coordinator on burn studies, polycystic kidney disease, post-kidney transplant, bariatric studies, acne, chronic obstructive pulmonary disease, pain, and cardiac device studies.
2. Acted as a backup coordinator on traumatic brain injury and cardiac disease.
3. Responsible for study start-up to study closure.
4. Successfully completed studies with good enrollment.
5. Collected blood, processed blood, and shipped specimens per protocol. 
6. Completed source documentation and case report forms on an EDC/EMR system.
7. Dispensed medication, and subject randomization through an IVRS/IXRS system.

Experience

2-5 Years

Level

Junior

Education

BS

Description :

1. Provided protocol-specific patient care, study drug accountability, and data entry.
2. Conducted research trials.
3. Provided consulting services to satellite sites to improve proficiency and direct patient care.
4. Recruited research participants thru advertisements and public relations.
5. Developed study budgets.
6. Conducted study participant visits, including organizing all visit procedures and completed periodic reviews, and communicated regularly with the Institutional Review Board. 
7. Maintained protocol requirements for patient visits, patient visit schedules, specimen collection, and drug accountability requirements. 

Experience

5-7 Years

Level

Executive

Education

B.S. In Health Care Administration