The Clinical Research Coordinator is responsible for coordinating and supporting clinical research studies within the Department of Obstetrics and Gynecology. This role includes participant recruitment and enrollment, obtaining informed consent, collecting and managing research data, ensuring compliance with institutional, regulatory, and ethical guidelines, coordinating study visits, maintaining study documentation, and serving as a liaison between investigators, study participants, and clinical staff. The Research Coordinator assists with Institutional Review Board (IRB) submissions, monitors study progress, and helps ensure the timely and accurate completion of research projects while promoting high standards of patient care and research integrity.

Please note this position is coterminous with research funding.

Regulatory and Compliance– 15%

• Maintains clinical study regulatory files (maintains all correspondence for regulatory files, obtains and delivers IRB correspondence, etc.). 
• Responsible for Institutional Review Board submissions follow-up, including amendments, continuing reviews, ensuring PI signature both electronic and paper.
• Responsible for tracking regulatory processes and keeping them moving forward and reporting status to the Research Manager on a weekly basis or as indicated. 
• Responsible for Medical Student Research Office communication, including ensuring medical students are approved to work on research studies.
• Responsible for communication with SNGH and CHKD research departments to obtain required approvals and updates for research conducted there.
• Act as a resource for helping MFM staff obtain and maintain required research training.
• Responsible for keeping study activity updated in computer files and regulatory binders.
• Other duties as assigned requested or required by the Clinical Research Manager.

Screening, Patient Consent, and Data Collection – 55%

• Screen potential research subjects using the electronic medical record and clinic schedule.
• Approach potential subjects and introduce studies.
• Conduct informed consent discussions and obtain written informed consent.
• Develop source documents, complete as needed and review and document where and how source was obtained.
• Develop case report form.
• Enter data on study specific electronic databases or case report forms.
• Review medical records and assemble and clarify data required.
• Prepare for and facilitate EVMS internal study audits of studies.
• Attend study-specific coordinator meetings.
• Complete documentation in case report forms; develop and maintain study specific source documents.
• Maintains required certifications (i.e. BBP, HIPAA, IATA).

Sponsor/Clinical Research Organization Liaison- 15%

• Participate in Site Qualification Visits, Feasibility Assessments, and Site Initiation Visits.
• Respond to sponsor inquiries and requests.
• Respond to sponsor site questionnaires and conduct site evaluation visits as needed, providing updated patient demographics and area census information.
• Responsible for the reporting of all Serious Adverse Events (IRB, CRO and sponsor submissions).
• Responsible for facilitating and participating in interim monitoring visits and close out visits and ensuring all documentation is prepared in advance.
• Work with study sponsor and monitors to resolve queries.
• Handle transmission and receipt of faxes, FedEx and UPS mail between sponsors and site.

Specimen Collection, Processing, Storing, and Handling – 15%

• Perform phlebotomy, urine, and other specimen collection and take vitals at clinical patient appointments. 
• Process specimens according to study procedures and lab manuals
• Store processed specimens according to study procedures and lab manuals
• Prepare specimens for shipment, including ordering dry ice, packaging and labeling shipments and coordinating with FedEx
• Maintain inventory of lab supplies for studies

Minimum Qualifications and Skills:

• Bachelor’s degree in science related field plus five (5) years of clinical research experience, or equivalent combination of education and experience.

Preferred Qualifications:

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