Clinical Research Coordinator Resume Samples

Description :

1. Coordinating the day-to-day activities of the research study team specifically engaged in carrying out the research clinical protocol.
2. Coordinating and actively recruits and formally consents study subjects for enrollment.
3. Preparing research study advertisements for submission to the institutional review board (IRB) for approval to aid in subject recruitment.
4. Performing input, retrieval, and analysis of data for processing and validation, and maintains research databases on excel.
5. Managing calendars and conducts telephone, face-to-face interviews, or sends emails for follow-up visits as per protocol to administer assessment data collection instruments.
6. Organizing and facilitates meetings, conferences, and other events associated with research activities.
7. Documenting all correspondence and communication pertinent to the research and responded to study site monitoring visit findings and, after consultation with pi, implements approved recommendations.
8. Maintaining documentation record of the investigational medicinal product received.
9. Maintaining weekly temperature logger readings of refrigerator storing study investigational medicinal product.
10. Preparing case files and maintains adequate and accurate source documentation for each study subject.

Experience

7-10 Years

Level

Executive

Education

MHA

Description :

1. Compiling, preparation, or collaboration on publications and/or presentations.
2. Collection and management of the secure storage of data including experimental logs, management, analysis, or interpretation of research data.
3. Initiating submission of regulatory documents to applicable research sub-committees, VA r&d committee, and sponsors.
4. Screening patients to determine study eligibility criteria by reviewing patient medical information or interviewing subjects.
5. Providing education and instruction of study medication use, administration, storage, side effects and notifies adverse drug reactions to the study site.
6. Providing education regarding study activities to patient, relatives and medical center staff as necessary per protocol.
7. Maintaining complete and accurate data collection in case report forms and source documents.
8. Initiating and/or expedite requests for consultation, special tests or studies following the investigator's approval.
9. Obtaining and organizing data such as test results, diaries/cards or other necessary information for the study.

Experience

7-10 Years

Level

Executive

Education

Certification

Description :

1. Lead coordinator for international study and serving as the lead for the clinical center.
2. Collaborating with the national base center in revising source documents and manual of operations.
3. Developing and updating clinical pathways for study visits based on good clinical practices.
4. Developing new source documents and a detailed training manual, known as our site operation manual.
5. Recruiting participants, determine eligibility, perform consent process and study visits.
6. Overseeing clinical practice of site and ensure multiple affiliates comply with the protocol.
7. Working closely with compliance and institutional review board to ensure all federal, state and local regulatory items are maintained for the conduct and management of the trial.
8. Ordering supplies, shipping samples, preparing for audits, and training new staff on the protocol.
9. Collaborating with other departments which led to a new workflow with lab for processing samples allowing for tracking and accountability.
10. Ensuring all records and source documents are maintained in an organized manner.

Experience

5-7 Years

Level

Executive

Education

BN

Description :

1. Coordinating several phases 3 clinical research studies in the field of ophthalmology.
2. Studies included treatments for wet age-related macular degeneration, geographic atrophy, diabetic retinopathy, and postoperative ocular inflammation.
3. Performing role of primary masked coordinator, primary unmasked coordinator, backup masked coordinator, or unmasked injection assistant depending on the study.
4. Recruiting patients presenting with conditions qualifying them for a study and setting up screening visits to determine if the patient can be enrolled in the study.
5. Guiding research recruitment efforts through staff education, reaching out to ophthalmologists, providing incentives to staff responsible for helping to enroll a patient in a study.
6. Conducting clinical research in accordance with good clinical practices.
7. Managing source documents and logging patient visit data into electronic data centers.
8. Recording all adverse events and reporting them according to study and IRB requirements.
9. Communicating with primary care physicians mutual patient study involvement and clinically significant abnormalities requiring their attention.
10. Requesting and documenting medical records from healthcare providers to document the medical history and adverse event details.

Experience

5-7 Years

Level

Executive

Education

BA

Description :

1. Effective internal and external recruitment for and complete all study-related activities within the study protocol.
2. Manage the device and pharmaceutical details as the study protocol requires.
3. Create source documents that effectively gather data needed for completion of the clinical trial.
4. Manage study data entry activity and ensure timely resolution on study data queries.
5. Proficient in the rave, immediate, oracle, inform, trial master entry systems.
6. Effectively review study protocol and provide the necessary training for specific tasks with the clinical operations team.
7. Delegate to and coordinate research assistants on projects to ensure compliance with protocol training, case report form specific guidelines, sops, and GCPs.
8. Problem-solving internally within operations in order to meet and exceed timelines.
9. Effectively delegate tasks and duties in order to successfully execute clinical trials.
10. Perform clinical activities including phlebotomy, patient assessment, vital signs and other needed procedures to ensure all data is captured per protocol.

Experience

7-10 Years

Level

Management

Education

GED

Description :

1. Conferring with study participants to explain the purpose of the study and obtain informed consent.
2. Following established guidelines in the collection of clinical data and/or administration of clinical studies.
3. Patient for study procedures; initiate/coordinate drug orders, laboratory procedures and treatments for patients based on standing protocol orders.
4. Collecting data from patient charts, medical records, interviews, questionnaires, diagnostic tests, and other sources; code, evaluate and interpret collected data and prepare appropriate documentation; obtain blood samples, cultures, tissues and other specimens for laboratory analysis.
5. Ensuring compliance with protocol guidelines and requirements of regulatory agencies; identify problems and/or inconsistencies and monitor patients progress to include documentation and reporting of adverse events; recommend corrective actions as appropriate.
6. Evaluating and interpreting collected clinical data in conjunction with the principal investigator(s) as appropriate; prepare an oral presentation or written reports and analyses setting forth progress, trends, and appropriate recommendations or conclusions.
7. Conferring with the principal investigator(s) in developing plans for research projects and to discuss the interpretation of results; collaborate on the preparation of manuscripts for publication.
8. Coordinating the development of forms, questionnaires and the application of research techniques; write procedures manuals for data collection and coding.
9. Reviewing journals, abstracts, and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies.

Experience

7-10 Years

Level

Executive

Education

Certification

Description :

1. Responsible for completing and maintaining case report forms, regulatory, source documents and other documents.
2. Attending weekly coordinator conference calls with the project manager and other participating sites.
3. Recruiting subjects from the weekly head and neck tumor board meetings and the bi-weekly head and neck management conference.
4. Visiting various clinics to see patients during their appointments; including the ent clinic and the oral maxillofacial surgery clinic at Bellevue hospital.
5. Holding team meetings with the dentists, dental hygienists, research coordinators and students as needed.
6. To inform the team of any changes that need to be made to make our study more efficient.
7. Process IRB and other regulatory documents under the FDA and IRB regulations.
8. Ensuring compliance with follow-up visits to the subject's enrolled in the study.
9. Conducting studies as per protocol, procedures and patient and physician interactions.

Experience

7-10 Years

Level

Senior

Education

BS

Description :

1. Maintaining required records of study activity including case report forms, drug dispensation records, or regulatory forms.
2. Scheduling subjects for appointments, procedures, or inpatient stays as required by study protocols.
3. Performing specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms.
4. Dispensing medical devices or drugs, and calculate dosages and provide instructions as necessary.
5. Recording adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
6. Assessing eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.
7. Preparing study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
8. Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
9. Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.
10. Participating in department meetings and nurse and resident physician education.

Experience

10+ Years

Level

Senior

Education

Diploma

Description :

1. Responsible for all aspects of conducting clinical trials to ensure strict protocol and food and drug administration regulations are met, good clinical practice (GCP) is utilized, as well as meeting study budgets and timelines.
2. Responsible for coordinating and conducting procedures to ensure study participants meet protocol inclusion and exclusion criteria.
3. Ensuring all procedures and techniques used to follow internal sops and external regulations and guidelines for participant safety.
4. Attending sponsor training sessions train staff prior to study start to organize and write clinical summaries.
5. Extensive communication skills both internally and client-based via physical, email, and telephone daily work with Microsoft excel and word documents ability to foresee the end result of a study and any discrepancies thereof to adjust and assure those discrepancies are null and void prior to study conduct.
6. Completed CRFS, maintained regulatory files in compliance with GCP/ich and FDA guidelines.
7. Ensuring study participant safety for inpatient and outpatient study periods.
8. Providing analysis for study protocol inclusion/exclusion criteria and prepares with the primary investigator safety reports for a trial sponsor.

Experience

7-10 Years

Level

Executive

Education

BS

Description :

1. QA multiple problem trials and successfully returned to excellent standing with the CRO.
2. Complete all forms and correspondence and reports to the CROs and sponsors in a timely manner.
3. Primary responsibility is to screen, enroll and follow study subjects ensuring protocol compliance and close monitoring while the subjects are on the study.
4. Responsible for all data collection, source documentation, developing/completing study-specific case report forms and submission of adverse experience reports.
5. Creating study specific tools for source documentation when not provided by the sponsor.
6. Ensuring compliance with protocol guidelines and requirements of regulatory agencies; identify problems and/or inconsistencies and monitor patients' progress to include documentation and reporting of adverse events; recommend corrective action as appropriate.

Experience

10+ Years

Level

Senior

Education

BA