The key person will coordinate the day-day activities of a federally funded randomized clinical trial, including screening and recruitment of research volunteers for the trial, conduct orientation sessions, assemble and maintain study participants charts, track study compliance, enter and quality control study database, and lead weekly research meetings.Job Duties
- Coordinate the research activities of the human clinical trial working closely with the PI.
- Specific Position Duties: As described in budget justification of the federally funded grant, they are: 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 and evaluation and recruitment of potential subjects.
- Will have primary responsibility for subject recruitment; screening and scheduling. He will conduct orientation sessions; prepare and send correspondence to participants' personal physicians; assemble and maintain study participant charts, track study compliance, enter data into the study database; and assist in preparation of the data for DSMB meetings.
- Will ensure documentation of consent process in patient's electronic record.
- In addition, he/she will instruct participants on the proper intake of metformin or placebo (e.g. two tablets bid with meals) and document compliance on standardized form.
- Will assist with muscle biopsies.
- Other duties will include: perform venipuncture for collection of blood samples, including processing of samples and proper shipment per regulatory guidelines; collect and maintain accurate source documentation for each study participants; accurately document in CPRS, complete data entry and respond to queries by investigative team and Data and Safety Monitoring Committee; assure confidentiality and security of human participants and data collected in accordance with HIPAA regulations; order supplies from SRM.
- Performs other job duties as assigned.
- High School diploma or GED.
- Three years of relevant experience.
Baylor College of Medicine requires employees to be fully vaccinated -subject to approved exemptions-against vaccine-preventable diseases including, but not limited to, COVID-19 and influenza.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.