Senior Clinical Research Associate

Title:  Senior Clinical Research Associate
Location:  New Haven, CT
Duration:  Direct Hire
Schedule:  M-F 37.5 hours, occasional evenings and weekend hours 
Target Start Date: ASAP

Responsibilities: 

• Incumbent conducts clinical research monitoring for clinical trials conducted 
• Working collaboratively with key stakeholders, this role advocates for the advancement of critical strategic objectives that promote effective, efficient, and compliant management of clinical studies. 
• Independently tracking, planning, ensuring the research activities are conducted in accordance with approved protocols and reporting monitoring activities.
• Developing project specific monitoring plans via evaluation of the project risk and in accordance with FDA guidance, as well as monitoring for multiple clinical trials. 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 Senior Clinical Research Associate may be responsible for management and oversight of protocol specific Data and Safety Monitoring Boards.
• Oversees the advancement and growth of the program.  Gives direction and leadership supporting the philosophy, mission, strategy, and annual goals and objectives.  Assumes primary accountability for disseminating and publishing all program information to create public awareness and support of the program. 
• Plays a key role in strategic planning. Works closely with leadership, internal and external colleagues and community residents to develop new initiatives to support the strategic direction of the organization and implements long-term goals and objectives to achieve the successful outcome of the program. 
• Develops an annual budget and operating plan to support the program. Ensures program operates within approved budget. Monitors and approves all budgeted program expenditures. Manages all program and project funds according to established accounting policies and procedures.

Requirements:

• Master’s Degree in related field preferred, Min Bachelor’s degree in a related field
• Experience in auditing or monitoring of clinical trials.
• SOCRA/ACRP (or equivalent) certification preferred
• Comprehensive understanding of clinical research review, approval and Data and Safety Monitoring processes. Comprehensive knowledge of federal regulations concerning the protection of human subjects and clinical trial design, implementation and analysis.
• Demonstrable understanding of clinical research processes and procedures from study start-up to study close out with an experience as a clinical research auditor, clinical research associate or equivalent. Extensive knowledge and application of auditing or monitoring techniques and practices.

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.

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