Research Coordinator I
The Section of Endocrinology is seeking a Research Coordinator I that will coordinate the day-day activities of a federally funded randomized clinical trial, including screening and recruitment of research volunteers for the trial, conducting orientation sessions, assembling and maintaining study participants charts, tracking study compliance, entering and quality control study database, and leading weekly research meetings. This position will also prepare regular reports to the external Data and Safety Monitoring Committee as well as all other regulatory requirements. The individual will report directly to the PI to ensure the progress of the clinical trial consistent with the study timelines of the grant protocol and thereby assist in fulfilling the specific goals of the grant protocol.
- Coordinates the research activities of the human clinical trial working closely with the PI.
- Responsible for submission of required regulatory documents to Investigative Review Board and Research and Development committees and subcommittees, preparation and updates of informed consent, data collection, evaluation, and recruitment of potential subjects.
- Responsible for subject recruitment; screening and scheduling.
- Conducts orientation sessions.
- Prepares and sends correspondence to participants’ personal physicians; assembles and maintains study participant charts, tracks study compliance, enters data into the study database; and assists in preparation of the data for DSMB meetings.
- Ensures documentation of consent process in patient’s electronic record.
- Instructs participants on the proper intake of the study drug and documents compliance on a standardized form.
- Performs venipuncture for collection of blood samples, including the processing of samples and proper shipment per regulatory guidelines.
- Performs bone mineral density studies, perform strength testing, make sure that patients are performing exercise training, collect and maintain accurate source documentation for each study participant, accurately document in CPRS, complete data entry and respond to queries by the investigative team and Data and Safety Monitoring Committee; assure confidentiality and security of human participants and data collected in accordance with HIPAA regulations.
- High School diploma or GED.
- Three years of relevant experience.
- Bachelor's degree in a related field.
- Prior experience with computer spreadsheets and database management.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.