Senior Research Coordinator

Summary

The Senior Research Coordinator in the Research Resources Office (RRO) manages the day-to-day activities of a multiple clinical research studies in various therapeutic areas such as Renal, Gastroenterology, Neonatology, Infectious Diseases, and Rheumatology among others. The primary responsibilities include patient enrollment, screening, monitoring of research participants, and reporting to the clinical research sponsor. The position is responsible for ensuring accurate data collection, documentation, organization and safety of study volunteers.

The RRO supports research efforts for pediatric investigators at Texas Children's Hospital. This position will work within a team environment comprised of research coordinators and data managers who are trained to provide cross-coverage. Advancement opportunities may be provided based on employee performance.

Job Duties

• Manages patient enrollment (recruiting, screening, and interviewing) and study consent process of patients into a clinical research study(s).
• Explains the study's processes and procedures to educate the study participants.
• Collects and records study data related to study procedures.
• Performs research related procedures as required such as EKGs/ECG's and administers study questionnaires to study participants.
• Responsible for electronic case reporting requirements in accordance with all FDA and clinical trial study requirements.
• Manages and enters study information into CTMS (clinical trial management system) database.
• Communicates with patients and families throughout study.
• Interacts with sponsors and/or coordinating sites as required to facilitate protocol activities and maintains current study documents.
• Collects, processes and stores or ships blood or biological specimens as outlined per study protocols and associated lab or procedural manuals, in accordance with IATA Guidelines.
• Maintains records and regulatory documents and records for the research study.
• Schedules research participant for tests and procedures such as laboratory tests, x-rays, and other studies specific study visits for the research protocol.
• Retrieves and submits test results to the appropriate party.
• Schedules and orders study supplies and equipment as necessary.
• Reviews protocol documents, including abstracts, text, and informed consent for relevant information.
• Prepares documentation necessary to obtain initial and continued approval for the specific research protocol.
• Collaborates with physician, mid-level practitioners, research nurses, and data managers to document patient care.
• Conducts subject research study education as required within the scope of practice.
• Submits serious adverse event reporting and follows-up as needed.
• Evaluates and analyzes clinical research data as appropriate.
• Assists or provides guidance and support to lower level team members.

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

• Advanced knowledge in Research Coordination and the ability to manage complex clinical trials.
• Certification as either a Clinical Research Professional (CRP), or Clinical Research Coordinator (CRC) from the Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP).

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.