Company Summary:

ERG is the largest independent clinical research site services company focused on special populations and is the market leader in CNS. With 12 wholly owned clinical sites and 12 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 240+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally.

The ERG portfolio consists of St. Louis Clinical Trials, Woodland International Research Group, Woodland Research Northwest, Midwest Clinical Research, Pacific Research Network, Clinical Pharmacology of Miami, Brain Matters Research, Neuropsychiatric Research Center and Endeavor Clinical Trials, all supported by an industry leading centralized infrastructure located in New Jersey.

Our mission is to provide the highest quality execution of clinical trials in all clinical research phases aimed at helping sponsor companies to get their life saving or life enhancing drugs to market as quickly and safely as possible. We accomplish this with employees who are passionate about clinical research, focused on patient care and respect and use excellence as their yardstick in everything they do each day.

Position Summary:

The Site Director will act as a supervisor and mentor to all staff at the research site and assist in overseeing employees performance, evaluations, corrective action plans, staff recognition, recruitment, on-boarding new hires, and the management of staff schedules. This position is essential in providing access to all resources for every employee to complete the training needed to perform their own job responsibilities. Not only is this position crucial to employees, but also will be evaluating and implementing study protocols.

Other functions of the job include, but are not limited to:

• Providing profitable management of the clinical research business, consistent with company policies, principles, strategies, and objectives.
• Accountable for the overall coordination, organization, and efficient implementation of clinical trials management, operations, and regulatory compliance.
• Participating in weekly Business Development calls to review the site's plans and receive feedback in relation to Go- No Go decisions.

Additionally this position works closely with the Chief Medical Officer, Principal Investigators, Recruitment Team and Clinical Research Coordinators to evaluate clinical trials and ensure that all study-related procedures are completed properly from a clinical and a regulatory perspective. In executing these position responsibilities, the Site Director is guided by Good Clinical Practices (GCP), International Committee on Harmonization (ICH) guidelines, HIPAA and company standard operating procedures and policies.

Essential Duties and Responsibilities:

• Employee Management Responsibilities
• Serving as supervisor and mentor to all direct reports as detailed by the organizational chart
• Performing and/or overseeing all HR responsibilities for reporting staff including but not limited performance evaluations, corrective action plans, staff recognition, recruitment and onboarding of new employees, and management of staff schedules
• Providing access and/or resources for all employees to complete the training needed to perform job responsibilities
• Working closely with the Director of Operations, develops and implements business plans for achieving the strategic and tactical goals and objectives of the business
• Maintain Standard Operating Procedures, working guidelines and associated training programs for the effective management of subject recruitment, appointment scheduling, informed consent, subject visits, source document preparation, timely Case Report Form and EDC completion and regulatory affairs
• Ensures that all staff are adequately trained and adhere to Standard Operating Procedure and working guidelines
• Participates in the weekly Business Development (BD) calls to review the site’s pipeline for planning purposes and to provide feedback
• Works with the BD team to complete feasibilities, expedite protocol reviews and “Go-No Go” decisions
• Evaluates study protocols (e.g., with respect to enrollment/retention potential, site capacity and capabilities, and other determinants of success), with input from the Principal Investigator, Recruitment Manager and Clinical Research team, as necessary and contributes to decision as to which studies to pursue
• Coordinates site visits and PI Meetings with the BD team and sponsoring organizations prior to study implementation, and works with Clinical Research Staff to provide ongoing coordination of sponsor communications thereafter
• Oversees plans for recruiting subjects into each study
• Directs activities of the Recruitment Manager
• Approves media and resources to be used for subject recruitment
• Approves communications strategies
• Responsible for proper implementation and utilization of subject database

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.

The ideal candidate will have:

• 3 years of clinical trial management
• 1 year staff management
• Bachelor’s degree

Knowledge, Skills and Abilities:

• Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and data management methods.
• Excellent verbal and written communication skills

Work Environment: This is a high growth, fast paced small organization. The ability to be productive and

successful in an intense work environment is critical.

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The above job description is not intended to be an all-inclusive list of duties and standards of the position.