• Identification and hiring of appropriate clinic staff, preparation of annual reviews and handing of performance issues, if any, with the assistance of the Human Resources Manager
• Oversees the training, mentoring and career development of all clinic staff
• Understands requirements for all studies and communicates to all personnel/departments involved in each study
• Works closely with recruiting manager to ensure study panelists meet protocol requirements
• Assists in clinic staff scheduling to ensure all studies are staffed appropriately
• Ensures studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and procedures
• Oversees the clinic conduct of each study and/or delegates supervisors to oversee when unavailable
• Ensures that supplies and equipment needed from clients are available for studies as necessary
• Identifies and provides solutions to clinical trial issues and/or risks
• Ensures inventory of internal supplies needed for studies is at a level to support current and upcoming studies
• Contributes to the preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
• Identifies, develops, and reviews company policies and procedures
• Works closely with sponsor’s and monitors during site qualification, monitoring, and auditing visits
• Identifies areas of improvement, especially related to quality and efficiency, and implements solutions
• Understanding of the site's P&L and how clincal operations can impact the P&L

Manages staff and resources while considering the P&L for the site

• Bachelor's Degree, preferably in science
• 5+ years in Clinical Research
• Minimum of 4 years of Supervisory/Leader experience
• Ability to manage and coordinate multiple projects in a fast-paced, highly professional environment
• Ability to develop collaborative relationships with internal and external stakeholders
• Strong decision-making/analytical skills
• Proficiency with Microsoft Office applications
• Knowledge of GCP/CLP guidelines and Federal Regulations related to the conduct of clinical trials, NIH training and CCRC/CCRA certification a strong plus
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations

The requirements listed above are representative of the knowledge, skills, and/or abilities required