Clinical Research Coordinator III

Coordinates all clinical research activities with minimal supervision. Adheres to the service values and principles as well as the principles of research ethics. Based on specific research program needs, patient facing vs. data administrative responsibilities will vary.

Essential Job Functions:

• Coordinates and oversees all aspects of clinical research projects, including study start-up, site qualifications, initiation, monitoring, and close-out visits.

• Oversees site visits, promptly addresses sponsor queries, and ensures strict adherence to study protocols and regulatory requirements throughout all study activities.

• Manages regulatory compliance and documentation processes, including preparing and maintaining regulatory documents, registering studies on clinicaltrials.gov if required, assisting investigators with regulatory submissions such as to the FDA, and developing and updating Standard Operating Procedures (SOPs) to ensure adherence to research protocols and regulatory standards.

• Promotes ethical conduct in research and ensures integrity in all aspects of study conduct and data handling.

• Manages logistical and administrative aspects of clinical research projects by maintaining inventory of supplies and equipment, preparing lab kits and requisitions, organizing, and maintaining study documents including regulatory binders and source documents, tracking deadlines for grants and deliverables, and constructing codebooks for data dictionaries.

• Manages participant engagement throughout clinical research studies by identifying and recruiting eligible subjects, conducting informed consent/assent processes, coordinating subject reimbursement, verifying participant eligibility, and serving as the primary point of contact for study-related inquiries and support.

• Manages the data lifecycle in clinical research by abstracting information from medical records, entering data into case report and study forms, preparing abstracted/coded data for analysis, conducting statistical analyses, and ensuring database validity and integrity through QA/QC checks and data monitoring processes.

• Manages some financial aspects of research projects by assisting in budget preparation and fund review, as well as supports the research central offices and Principal Investigator (PI) in grant preparation and reporting activities.

• Provides comprehensive training and mentorship to research personnel by assisting in study conduct training, serving as a mentor and resource, and assists the onboarding process for new study team members.

• Leads the dissemination of research findings through manuscript preparation, collaboration on abstracts/posters, presentation of research at national meetings, or coordination of research education conferences.

• Other job functions as assigned.

Knowledge, Skills, and Abilities:

• Bachelor's degree and two or more years research experience required.

• Two-three years with complex research projects preferred.

• Strong organizational skills with ability to manage multiple simultaneous studies.

• Strong verbal and written communications skills.

• Strong knowledge of FDA, HSR, and GCP Guidelines.

• Strong analytical skills with the ability to recognize quantitative and qualitative research methods and remain agile and adaptable to various technological systems.

• May assist in technology system implementation.

• Strong leadership skills with the ability to prioritize tasks, problem solve, and serve as a mentor. Ability to foster an inclusive environment where all team members feel valued and respected.