The IMA Group is conducting a search for a Clinical Research Site Manager for its Manhattan Medex Healthcare office.
Position Purpose: Day-to-day management of site clinical research activities including the direct supervision of Clinical Research Staff, ensuring compliance with all applicable regulations and guidelines
Specific duties and responsibilities, including but not limited to:
Encourage and perpetuate a culture of TEAMWORK, safety and respect for every employee.
Apply and adhere to Company Policies, Standard Operating Procedures (SOPs), and processes that allow for the delivery of quality services to internal and external customers.
Ensure all clinical research activities are conducted in compliance with all applicable regulations and guidelines.
Observe and uphold a standard of strict confidentiality.
Oversee and directly participate in the day to day operations of all clinical research activities under the direction of the Vice President of Clinical Research, ensuring an efficient daily workflow with quality services are delivered in a coordinated, integrated manner.
Direct and facilitate the timely completion of all operational aspects of clinical research studies at the site in relation to:
New protocol feasibility assessment.
Create study budgets in collaboration with leadership.
Study Participant recruitment, screening, consenting, enrollment, payment, and retention.
Coordinates all aspects of study visit as delegated by the Principal Investigator.
Protocol set up in CTMS and maintenance of study within CTMS for the lifetime of the study
Data collection and maintenance of study records, including electronic and paper documentation
Meet regularly with leadership and the business office regarding study financial management aspects, including budgets, income, and expenses.
Facilitate the timely completion and quality assurance of regulatory documents related to each study.
Collaborate with leadership and principal investigators on evaluation and implementation of new initiatives and studies.
Develop, maintain, and present management reports on all site clinical research activity, including study metrics and financial management.
Serve in investigator role as applicable (i.e., nurse practitioner, PA-C)
Direct oversight of all site clinical research personnel and operational activities:
Recruit, train, mentor, and supervise Clinical Research Coordinators, Nurses, and Research Assistants.
Create staffing assignments and ensure staff training for new studies.
Set performance goals and expectations and conduct performance evaluations for staff.
Oversee and assist in the development of ways to encourage and reward excellent job performance.
Monitor performance, attendance, certifications, and required documents of Clinical Research staff.
Lead the development, implementation, and maintenance of SOPs, working instructions, tools, and templates related to Clinical Research Operations.
Evaluate and develop techniques for quality control and quality assurance of operations to ensure quality, reliability and safety.
Document and deliver both positive and negative feedback when and where warranted; working with leadership and HR on issues as needed.
Perform annual performance appraisals on quantifiable and objective criteria utilizing agency forms, conversation records, written employee warnings and checklists designed for evaluations.
Arrange and facilitate monthly meetings (and more frequently as needed) with staff and provide mandated training and updating.
Promote communication and positive resolution of issues among staff.
Provide coverage for office staff as needed.
Travel to other locations as needed.
Perform other related duties as assigned and work hours necessary for completion.
Required: Bachelor’s Degree
Preferred: Master’s Degree, RN, Nurse Practitioner license or PA-C, SoCRA CCRP certification
Required: Clinical trial experience with overall knowledge of industry and experience conducting clinical trials.
Preferred: Management experience with a proven track record to oversee multiple employees across multiple locations.