Senior Research Coordinator
Manage an exciting investigator initiated, industry sponsored, 2 center randomized controlled clinical trial testing the efficacy of an immunomodulator in hospital inpatients with COVID-19. This senior research coordinator will lead a team of investigators, site managers, personnel and statisticians to complete this trial with sponsor (Baylor College of Medicine) and a second site (Brigham Woman's). They will demonstrate a knowledge of regulatory affairs for clinical research at an academic medical center or hospital and have broad knowledge of IRB and FDA process.
- Lead a team of investigators, site managers, personnel and statisticians to complete this trial with sponsor and second site
- Interviews, screen and recruits patients for study; explains process and procedures to educate participant regarding the research study.
- Collects patient information; processes documents and enters information into a database.
- May perform Venipuncture (blood draws), EKGs/ECG’s and obtain vital signs on study participants.
- May collect, process, ship, and maintain paperwork for blood and/or biological specimens according to procedures outlined in study protocol. Employees may be required to receive on the job training of phlebotomy and EKGs/ECGs prior to performing on study participants.
- Maintains records and regulatory documents and records for research studies.
- Schedules research participant for tests and procedures such as laboratory tests, x-rays, and other studies specific for the research protocol.
- Prepares abstracts and manuscripts to contribute scientific and clinical results.
- May coordinate travel requests and reimbursements for research residents within College and Department Handles regulatory responsibilities for this trial including reports to the FDA and other regulatory bodies.
- Retrieves and submits test results to appropriate party.
- May correspond with patient throughout study.
- Orders supplies and equipment.
- Education Required: Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
- Experience Required: Five years of relevant experience.
- Certification/Licenses/Registration: None Required.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.