Clinical Research Associate - Clinical Research Center

Clinical Research Associate - Clinical Research Center

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Job Summary: As a specialized research professional the Senior Clinical Research Associate (SrCRA) collaborates with the Principal Investigator (PI) in leading all activity associated with research study protocols. This includes but is not limited to; research conduct, budget negotiation & management, initiating collaborations with other investigators and areas pertinent to the performance of the study, monitoring research progress and making necessary changes towards process improvement, leading efforts to initiate new studies, attending IRB meetings to expedite the start-up process. The SrCRA supervises all study activity and may delegate responsibilities to Research Assistants and/or Research Associates as appropriate. In addition, the SrCRA supervises HHC approved Research Volunteers. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the SrCRA leads, facilitates and coordinates all clinical trial activities playing a critical role in the supervision and conduct of the study. By performing these duties, the SrCRA works with the PI, department, sponsor, IRB and institution to support and provide guidance on the administration of the compliance, financial, personnel and all aspects of the clinical study.

Job Responsibilities:

• Compiles and extracts data by performing and reviewing patient information to ensure integrity of patient data for analysis and development of protocols.
• Enrolls patients in studies by screening for eligibility criteria, consulting with physicians and obtaining patient informed consent to ensure patient safety preserved and regulatory standards are met.
• Instructs hospital staff and physicians on current study by familiarizing them with protocol requirements to assure proper execution.
• Works effectively as a team member both within and across clinical settings to promote an integrated delivery of health care services through communication, cooperation and collaboration.
• Train, mentor and supervise lower level research staff, students, interns, and volunteers
• Assign tasks to Clinical Research Assistants and Clinical Research Associates as appropriate in collaboration with the CRC manager
• Support other staff in all aspects of study conduct including, oversight associated with meeting the goals outlined in the protocol and clinical trial agreement
• Motivate others, monitor study performance and lead study meetings
• Manage complex multisite, interventional high risk drug/device research protocols
• Presents at conferences (abstracts, poster presentations) and assists in preparation of manuscripts
• Must have in depth knowledge of at least one clinical area
• Serve as CRC leader internal/external, advising other staff regarding complex protocols and projects in one or more clinical area
• Provide a leadership role in developing, implementing, and evaluating the conduct of clinical research
• Takes a lead role and/or coordinates or presents at internal external clinical research education event/conferences
• Lead activities designed to improve organizational performance metrics
• Reviews and develops a familiarity with the clinical trial agreement and/or award terms and conditions.
• Works with the PI to assure that the study is in compliance with all terms and conditions, including but not limited to education, IRB (HRPP) approval, conflict of interest disclosure, health and safety protections for participants and staff and any financial terms or conditions
• Coordinates appropriate and timely payments to participants (if applicable) in accordance with policies and procedures
• Contributes directly regarding continued and yearly performance appraisal of Clinical Research Center team members
• Promotes and monitors lower level personnel regarding the ethical conduct of research by assuring that good faith suspicions of misconduct in research as defined within Research Administrations Policy and other misconduct as described in HHC Code of Conduct are reported appropriately.
• Registers (if required) studies on ClinicalTrials.gov and maintains current and accurate information
• Coordinates all aspects of study activity as required of a Clinical Research Associate ***This is a grant funded position***

Qualifications: Bachelor degree in an appropriate science discipline such as biology, psychology, etc. On a case by case basis, Associate degree may be considered with significant years of research experience, Master's degree preferred. Five years of clinical research experience. Or, seven years of practical clinical research experience is required with an Associate degree.