Clinical Research Site Manager

The CompanyOur client is looking for a Clinical Research Site Manager for their rapidly expanding company that has recently secured additional investment to fuel their growth. Established in 2015, they have expanded to 11 sites, conducting over 400 clinical studies spanning Phase I to IV, primarily focusing on GI, Hepatology, and CNS.

This role will be onsite in Houma, LA!

The RoleThe Clinical Research Site 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/supervision of all research personnel, overseeing goal performance, and physical space management.

Manage all day-to-day operations of the clinic and train and develop staff.Organize all aspects of the clinical trials assigned and ensure successParticipate in investigator meetings, site initiation meetingsWork with our internal patient recruitment department for participant screening and enrollment and ensure compliance with protocol and all applicable regulations.Conduct Informed consent process and conduct study related visits.Monitor subjects per protocol requirements.Assess, monitor, and report adverse events per protocol.Maintain required records of study activity including source documentation, case report forms, drug dispensation records, and data management system entry.Complete case report forms and resolve queries.Provide assistance to fellow study coordinators including obtain, process and ship study related specimensManage quality assurance assigned protocols per site SOP’s.Assist with Clinical Research Coordinator duties, including Phlebotomy, EKG and vitals as needed.

Qualifications5+ years of Clinical Research experience at the site level.2+ years of direct people management experience (with at least 2 direct reports).Willingness to jump in hands-on as a CRC.Willingness to work on-site Monday through Friday.