Senior Research Program Coordinator II

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Under general supervision of the Research Nurse Manager, the Senior Research Program Coordinator II will assist principal investigators and research staff with multiple clinical research projects. This includes regulatory review, site study team training, data monitoring and integrity management, patient enrollment, and overall project timeline management for the GBMC Research Program. This requires a high level of knowledge, oversight, and organization, and will serve as a central resource for principal investigators and staff conducting clinical research.

Responsibilities will also include orient and train research staff in the program and assist with general operations of the program.

Bachelor’s Degree in related discipline required. Master’s Degree preferred.

At least six years’ related experience, experience in a clinical trials office preferred.

• Advanced computer skills and knowledge of database management (e.g., Microsoft Office, Medidata Database, Redcap Database).
• Organizational skills enabling many diverse tasks to be managed at the same time.
• Prioritization skills in order to manage a large caseload of both open and follow up trials.
• Analytical ability in order to develop and manage the data collection process, to process research data, and generate summary reports.

• Certification as a Clinical Research Associate from SoCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals), required or eligible to obtain certification within a year of hire.

• Assist principal investigators with multiple clinical research projects. Work on clinical studies requiring a high level of knowledge, coordination and data abstraction.
• Assist clinicians with patient screening, consenting and verification of patient eligibility for studies.
• Conduct intervention trials and international studies in compliance with International Council of Harmonization (ICH) regulations.
• Explain protocol procedures to patients and obtain informed consent.
• Contact patients at the appropriate time to assure completion of protocol requirements.
• Be responsible for organization and completeness of clinical research data, including data entry, maintenance of records and accuracy of the data.
• Design and compile materials and standard operating procedures which aid physicians and other staff in complying with protocol requirements.
• Establish study calendar of various clinical protocols and coordinate the logistics needed for successful completion of the studies.
• Collection, processing and shipping of biospecimen as requested by research protocols according to DOT/IATA regulations.
• Collect patient source documents and case report forms for analyzing patient data.
• Act as primary contact for study participants, which may include scheduling, confirming appointments, and escorting/directing to various locations on campus.
• Perform assessment tools and questionnaires.
• Coordinate the collection and documentation of patient information for research purposes.
• Organize and create clinical research charts to be reviewed by regulatory agencies.
• Maintain a research database of patients enrolled in clinical trials.
• Participate in and or organize community events to increase public awareness.

• Responsible for Institutional Review Board (IRB) submission, verification and maintenance of protocol specific information. Prepare and submit annual renewal requests, amendments and safety reports according to IRB requirements.
• Assist the Regulatory Specialist with new IRB submissions as needed.
• Ensure smooth study activation by working closely with the Regulatory Specialist, PI, and Research Nurse, and collecting all regulatory documentation.
• Work closely with Regulatory Specialist and clinical trial sponsor to ensure all documents are ready prior to study activation.
• Maintain regulatory binders per protocols.
• Establish regular meetings with PI, Research Nurse, and Study Coordinators to discuss protocol amendments, deviations, adverse…