The Clinical Research Coordinator position manages daily operations of clinical trials and studies, acting as the key link between the principal investigators, study participants, faculty/staff and sponsors ensuring studies run smoothly and ethically through management of participant recruitment, data collection, regulatory documentation, and monitoring study participant safety. This position is crucial for coordinating everything from study startup to closeout, requiring strong organizational and communication skills to manage multiple studies, strict protocols, and detailed record-keeping.

Please note this position is coterminous with grant funding.

Study Coordinator – 90%

• Manage studies per FDA, GCP and ICH regulations following the guidelines that apply.
• Develop Informed Consents, obtain informed consent and assure that anyone listed on the study delegated to obtain consent is doing so per regulations and that consent is documented appropriately and maintained per SOPs for review.
• Develop source documents, complete as needed and review and document where and how source was obtained.
• Develop case report forms for investigator-initiated studies.
• Enter data on study specific electronic databases or case report forms.
• Complete data collection for clinical trials.
• Review medical records and assemble and clarify data required.
• Complete study screening and recruitment for all assigned clinical trials.
• Respond to sponsor inquiries and requests.
• Responsible for contributing to Clinical Research SOPs.
• Prepare for and facilitate internal, external, and FDA study audits.
• Attend various conferences, both by phone and central meeting with other centers and sponsors pertaining to current or proposes studies.
• Respond to sponsor site questionnaires and conduct site evaluation visits as needed, providing updated patient demographics and area census information.
• Complete documentation in case report forms; develop and maintain study specific source documents.
• Work with study sponsor and monitors to resolve queries in a timely manner or in the timeframe required by the sponsor.
• Facilitate the collection of biological samples, including drawing blood, process, prepare store or ship as required and maintain log book.
• Assist with ordering study supplies.
• Provide pricing of study procedures and supplies as needed for development of budgets, along with T&E of staff being charged to study.
• Coordinate pre-study start up, interfacing with scheduling, billing, health services and other required areas. Continue communication with all areas to update on study status.
• Responsible for the reporting of all Adverse Events, Serious Adverse Events, Unanticipated Problems, and Protocol Deviations (IRB, CRO and sponsor submissions) in accordance with timeline and requirements of IRB and Sponsor.
• Review clinical patient appointment schedules for possible eligibility of participants in clinical studies and communicate with providers about potential research patients on their schedules.
• Maintain required certifications (i.e. BBP, HIPAA, IATA, GCP)

Regulatory – 10%

• Assist Regulatory Coordinator in maintaining clinical study regulatory files (all correspondence for regulatory files, obtains and delivers IRB correspondence, etc.)
• Assist Regulatory Coordinator with Institutional Review Board submissions and follow-up, including amendments, continuing reviews, ensuring PI signature both electronic and paper.
• Maintain and acquires updated lab certifications, CLIA certificates for laboratories utilized by studies at HH, Riverside, and Princess Ann offices. Maintains scanned copies accessible via the computer.
• Maintain and acquires copies of all training required for research investigators and their staff, genetic counselors, and Ultrasonographers, other staff, fellows, residents and students listed on studies, updated CVs and licenses for all study staff for files, regulatory binders and forwarding to sponsors. Maintains scanned copies accessible via the computer.
• Act as a resource for helping staff obtain and maintain required research training.
• Maintain files of computerized standard letters and forms for study specific needs and correspondence.
• Compile reports using Power Point (or related software).
• Responsible for keeping study activity updated in computer files and regulatory binders.
• Handle transmission and receipt of faxes, FedEx and UPS mail between sponsors and site.
• Arrange meetings and meeting rooms as required.
• Provide interdepartmental support as needed.
• Other duties as assigned requested or required.

Required:

• Ability to think and work independently, insight, excellent organizational skills, astute and accurate patient assessment skills, and the ability to identify and assign priorities.

Preferred:

• Bachelor’s degree in science related field
• Five (5) years of clinical research experience