As key personnel in the clinical trial , the research coordinator will be responsible for submission of required regulatory documents to BRAIN, subject recruitment, screening, and scheduling, document consent process, collect and maintain accurate source documentation, complete data entry, document in computerized patient record , maintain study participant charts, enter data into the study database and assist with DSMB meetings.
Coordinates day to day activities of research protocols which include screening, enrollment, and monitoring of research participants. Ensures accurate data collection, documentation, organization and safety of research participants.
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.
Primary responsibility for subject recruitment; screening and scheduling.
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.
Ensure documentation of consent process in patient’s electronic record. In addition, he/she will instruct participants on the proper intake of the study drug and document compliance on standardized form.
Other duties will include: perform venipuncture for collection of blood samples, including processing of samples and proper shipment per regulatory guidelines; perform bone mineral density studies, perform strength testing, make sure that patients are performing exercise training, 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.
Education Required: High School diploma or GED.
Experience Required: Three years of relevant experience.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
Baylor College of Medicine fosters diversity among its students, trainees, faculty and staff as a prerequisite to accomplishing our institutional mission, and setting standards for excellence in training healthcare providers and biomedical scientists, promoting scientific innovation, and providing patient-centered care.
- Diversity, respect, and inclusiveness create an environment that is conducive to academic excellence, and strengthens our institution by increasing talent, encouraging creativity, and ensuring a broader perspective.
- Diversity helps position Baylor to reduce disparities in health and healthcare access and to better address the needs of the community we serve.
- Baylor is committed to recruiting and retaining outstanding students, trainees, faculty and staff from diverse backgrounds by providing a welcoming, supportive learning environment for all members of the Baylor community.