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Sr. Clinical Research Coordinator
ComriseManchester, NH, United States30+ days ago
Job type
- Full-time
- Quick Apply
Job descriptionPerform routine operational activities for multiple research protocols Liaise between site research personnel, industry sponsors, and Supervisor Collaborate closely with various site departments / teams, including finance, relevant hospital administrative representatives, and the local IRB, if applicable Coordinate schedule of assessments from initial submission of feasibility until study closeout Coordinate submission and approval for the Site's Facility Review Committee, if applicable Provide awareness of research protocols to appropriate site-level personnel, including physicians, nurses, clinical staff, and administrators Document all specific tasks required by the protocol (i.e. medication forms, quality of life questionnaires, neuro exams, vital signs sheets, times of lab draws, etc.) Accurately perform / calculate and documents the BSA, mRS, NIHSS, STS risk score, or any other approved CRC task, as needed per protocol Document all patient, staff, and sponsor correspondence, including follow-up encounters, adverse events, interventions, pharmacy dispensations, and patient phone calls Ensure follow-up appointments, imaging, or any related procedures are scheduled correctly according to protocol requirements Accurately complete all data requests (including queries) and submit with source documentation within the timeframe specified in the SOP Re-consent patients in a timely manner and document process appropriately Support study team in mitigating risks and optimizing site compliance Work with site personnel and local investigators to assess site feasibility and performance Regularly meet with physicians and administrators, when applicable, to assess study performance and investigator satisfaction Collaborate with other departments (non-invasive, finance, laboratory, etc.) to develop and implement processes in support of the research activities Assist with providing a research update during Site Administrative meetings (Section meetings, Site Service Line meetings, etc.) Able to guide research team members on the management of non-compliant data and / or study activities Monitor patient enrollment at the site through weekly reports, and reports results to Supervisor Facilitate continuing education and training to investigators, as applicable Bachelor's Degree - Required Master's Degree - Preferred 1+ years of relevant experience - Required 5+ years of relevant experience - Preferred Certified Clinical Research Coordinator (ACRP or CCRP) - Preferred. Knowledge of organizational policies, standard operating procedures and systems. Demonstrate understanding and application of ICH guidelines and the Code of Federal Regulations within the clinical research environment. Fundamental understanding of medical and research operations terminology. Recognize circumstances requiring prompt escalation to PI, IRB and / or Supervisor. Effective communication skills Strong organizational skills and time management Basic clinical trial procedures, including ECG acquisition, phlebotomy, and specimen processing, handling, storing, and shipping. Effective interfacing with site stakeholders. Interpersonal skills Self-motivated Meticulous eye for detail The role may require competency in performing clinical tasks, including ECG, phlebotomy, and the process of handling, centrifuging, storing and shipping of specimens.
Summary :
The Senior Clinical Research Coordinator is responsible for coordinating multiple research protocols; serving as a liaison with local investigators and research personnel; and acting as a central resource for assigned research projects. The individual in this role offers a significant contribution to the development of processes, tools, and training necessary to maintain site compliance and patient safety.
Duties include but are not limited to :
- Practices and adheres to the "Code of Conduct" philosophy and "Mission and Value Statement"
- Demonstrate ability to fulfill responsibilities and duties of the CRC Level I and II
- Assist with training CRC Level I and II personnel
- Act as a role model to peers
Clinical Research Operations
Site Development
Reporting and Analysis
Education & Experience :
Licenses, Certifications, & Training :
Knowledge, Skills, Abilities, Behaviors :
Knowledge :
Skills :
Abilities :
Clinical Competencies :
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Clinical Research Coordinator • Manchester, NH, United States
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