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Senior Research Coordinator - Medicine - Infectious Disease

Baylor College of Medicine Prod

Houston · TX · us 55m ago

Job description

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.

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