About this role
- Summary Coordinates day to day activities of research protocols which include screening, enrollment, and monitoring of resesarch participants.
- Ensures accurate data collection, documentation, organization, and saftey of research participants.
- May supervise, schedule, and direct the activities of the less experienced research personnel.
- Job Duties Clinical Research Coordination (30%) Coordinate the day-to-day activities of assigned clinical research protocols, including participant screening, enrollment, scheduling, monitoring, and follow-up.
- (8%) Interview, recruit, screen, and educate prospective research participants regarding study objectives, informed consent, protocol requirements, and study procedures.
- (7%) Monitor participant progress throughout the study to promote protocol adherence, participant safety, and retention.
- (5%) Schedule research participants for protocol-required visits, laboratory testing, imaging, and other study-related procedures.
- (4%) Serve as a primary point of contact for research participants and study personnel, responding to questions and facilitating communication throughout the study.
- (6%) Clinical Procedures and Specimen Management (15%) Perform protocol-required clinical procedures, including venipuncture, electrocardiograms (EKGs/ECGs), collection of vital signs, and other research-related procedures within scope of practice and training.
- (7%) Collect, process, package, ship, and maintain documentation for biological specimens in accordance with study protocols, laboratory procedures, and regulatory requirements.
- (6%) Retrieve laboratory and diagnostic test results and communicate findings to appropriate study personnel as required by protocol.
- (2%) Data Management and Study Documentation (15%) Collect, verify, document, and enter research data into study databases while ensuring accuracy, completeness, confidentiality, and compliance with study protocols.
- (7%) Maintain complete and accurate study records, source documentation, and research files in accordance with institutional policies, sponsor requirements, and applicable regulations.
- (6%) Prepare reports, maintain study logs, and assist with monitoring study progress and research metrics, as requested.
- (2%) Regulatory Compliance and Research Quality (15%) Maintain regulatory documentation and study records to support compliance with institutional policies, sponsor requirements, Good Clinical Practice (GCP), and applicable federal and state regulations.
- (4%) Assist with the preparation and submission of Institutional Review Board (IRB) applications, protocol amendments, continuing reviews, renewals, and study closeout documentation.
- (3%) Monitor research activities to ensure adherence to approved protocols, regulatory requirements, and departmental procedures.
- (4%) Support quality assurance and quality improvement activities by identifying documentation deficiencies, implementing corrective actions within scope, and assisting with audit and monitoring activities.
- (4%) Research Operations and Administrative Support (10%) Coordinate study activities to support timely completion of protocol milestones and research objectives.
- (4%) Maintain inventory of study supplies, equipment, and research materials; prepare purchase requests and assist with tracking study-related expenditures and financial documentation, as assigned.
- (3%) Coordinate with investigators, sponsors, laboratories, pharmacies, and ancillary departments to facilitate study operations.
- (3%)
Minimum Qualifications
- Bachelor's degree in a Basic Science or related field.
- Four years of related experience may substitute for degree requirement.
- Five years of relevant experience.
Preferred Qualifications
- Bachelor's degree in a scientific, healthcare, or related field preferred.
- Experience coordinating clinical research studies and working with study participants.
- Working knowledge of research databases and electronic systems, including REDCap and Epic.
- Proficiency with Microsoft Office Suite, particularly Excel, Word, and Outlook.
- Experience with regulatory documentation, protocol compliance, and IRB processes.
- Ability to provide guidance, training, and support to junior research staff and team members.
- Strong organizational skills with the ability to manage multiple priorities in a fast-paced research environment.
- Excellent verbal and written communication skills.
- Bilingual Spanish proficiency preferred but not required.
- Candidates with a medical degree and some clinical research experience are encouraged to apply if they are interested in building a long-term career in clinical research.
- Demonstrated ability to work independently while collaborating effectively within a multidisciplinary team.
- Work Authorization Requirement: This position is not eligible for visa sponsorship.
- Candidates must be legally authorized to work in the United States at the time of application and throughout the duration of employment.
- Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.