Clinical Research Manager (Site Level)

Highlights:

• Manage the clinical site team and site operations
• Lead and manage a site from a strategic level and help the site become successful
• Work with a smaller, but face paced, clinic; Great Teamwork!
• Convenient location, easily accessible by subway

The Company

Our client is a fast growing clinical research site network with over 10 sites. They manage clinical studies in Phase I - IV in therapeutic areas mainly focused in GI, Hepatology, and CNS! Their goal is to be the best place to work in the country, and they are excited to find people excited to make that vision come to life through quality patient care and research.

The Role

The Clinic Manager is responsible for directly overseeing the day-to-day clinical operations including planning, organization, and implementation of all aspects of daily clinical research functions. Ensuring optimal conduct of studies, maintaining protocol compliance, meeting clinical data quality standards, optimizing operational flow and continuous monitoring/oversight of clinical trial operations. Also the management and supervision of all research personnel such as overseeing goal performance

• Directly manage site staff
• Manage staffing needs and maintaining staff (interviews, training, performance reviews, etc)
• Mentor and support direct reports in their responsibilities and functions.
• Develop and refine subject visit flow and subject binders to ensure on time data capture by properly delegated staff for each subject visit
• Manage and track vital trial metrics and operational objectives for the trial are in conformance to all relevant laws, regulations, GCP guidelines, protocol, and internal SOPs/policies.
• Study start up, ensure all protocol requirements are met, ordering of proper supplies, development of vendor relationships, coordinate staffing and proper coverage
• Distribute studies among coordinators, considering the site, coordinator, subject, experience, training & sponsor needs.
• Participate in the conduct of PSSVs, SIVs and introduce self to all CROs, Project Managers, CRAs
• Provide back-up for appropriate study tasks, as dictated by patient flow and staff coverage
• Maintain oversight of accurate and efficient data entry into all systems
• Address all patient, vendor, and sponsor complaints
• Facilitate the Quality Control process

Qualifications:

• Bilingual Spanish/English (or comfortable enough in both languages to discuss complex medical terms with patients and vendors)
• 5+ years Clinical Research experience at the site level
• 1+ years direct people management experience
• Willingness to jump in hands on as a CRC as needed