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Title: Clinical Research Associate (Monitor) Location: New Haven, CT (remote will be considered) Duration: Direct Hire Schedule: M-F 37.5 hours, occasional evening and weekend hours Target Start Date: ASAP Responsibilities: Reporting to the Assistant Director of Quality Assurance (QA) and Monitoring, the incumbent conducts clinical research monitoring for clinical trials conducted. The Clinical Research Associate will be responsible for independently tracking, planning, ensuring the research activities are conducted in accordance with approved protocols and reporting monitoring activities. The monitoring activities performed include but are not limited to: Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, Close Out Visits per protocol specific monitoring plans.
The mission of the Office of QA & Monitoring is to foster a supportive environment conducive to achieving clinical research mission and provide a central resource to aid investigators, research groups and leadership with respect to trial development, execution, and oversight.
Works directly and in collaboration with leadership, Departmental leaders, investigators, research staff, HRPP and the IRB to facilitate the review the activities associated with human subject research in terms of safety, compliance, and integrity of clinical trials and at collaborating institutions.
Evaluates clinical trial conduct to ensure research integrity and compliance with institutional policies, state and federal regulations, and Guidelines to Good Clinical Practice
Identifies research non-compliance and reports to appropriate leadership, HRPP, the IRB and the OGC.
Provides educational and corrective action advice to faculty in preparation for FDA audits. Serves as liaison between the investigator, the research team and the FDA during an actual inspection. Records proceedings and summarizes inspection activity in real time.
Consults to investigators needing data safety monitoring plan details/information for their grant application. Develops Data and Safety Monitoring Plans based on the risk assignment categories.
Provides direction to investigators to strengthen their research and ensure regulatory and protocol compliance.
Integration of Data Safety and Monitoring Plans and QA findings with committees and educational plans.
Requirements:
Master's Degree or other advanced degree in related field Preferred
Bachelor Degree in related field and five years of related experience or an equivalent combination of education and experience required
GCP training required within 3 months of hire.
Self-directed with the ability to work, plan, research, and conduct projects with minimal supervision and on a flexible schedule.
Organized and capable of handling multiple/diverse projects simultaneously.
Advanced interpersonal, oral and written communications skills and ability to work effectively with a wide variety of external and internal stakeholders.
Demonstrable understanding of clinical research processes and procedures from study start-up to study close out.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Vacancy expired!