Site Director

About the Company

Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.

We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.

About the Role

The Site Director is responsible for the 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. Works closely with the Chief Operating Officer, Therapeutic Lead, 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 regulatory perspective. This role is guided by Good Clinical Practices (GCP), International Committee on Harmonization (ICH) guidelines, HIPAA, and company standard operating procedures and policies.

Responsibilities

• Employee Management
  • Serve as supervisor and mentor to all direct reports as assigned.
  • Perform and/or oversee all HR responsibilities for site staff including performance evaluations, corrective action plans, staff recognition, recruitment and onboarding of new employees, conflict resolution, and management of staff schedules.
  • Provide access and/or resources for all employees to complete the training needed to perform job responsibilities.
• Planning and Management
  • Develop and implement business plans for achieving the strategic and tactical goals and objectives of the site business in collaboration with the site head of Operations.
  • Maintain Standard Operating Procedures, working guidelines, quality management plan, and associated training programs for effective management of clinical trial delivery, including subject recruitment, appointment scheduling, vendor contracting, IRB approval and interactions, informed consent, subject visits, subject stipend delivery, source document preparation, and timely completion and entry of Case Report Forms in EDC and Clinical Trial Management System.
  • Manage and motivate site staff to contractual and expected enrollment goals.
  • Ensure all staff are adequately trained and adhere to Standard Operating Procedures and working guidelines.
• Business Development
  • Participate in Business Development calls and forums to review the site’s pipeline and provide feedback.
  • Work with the BD team to complete feasibilities, expedite protocol reviews, and make “Go-No Go” decisions.
  • Evaluate study protocols for enrollment/retention potential, site capacity and capabilities, and other determinants of success, with input from the Principal Investigator, Recruitment Manager, and Clinical Research team.
  • Coordinate site visits and PI Meetings with sponsoring organizations and Clinical Research Staff; provide ongoing coordination of sponsor communications thereafter.
  • Interface proactively and collaboratively with centralized services (e.g., Quality Assurance, Central Recruiting, Business Development).
  • Serve as primary point of contact at the site for ERG leadership.
• Subject Recruitment
  • Oversee and coordinate plans for recruiting subjects into each study.
  • Responsible for proper implementation, expansion, and utilization of subject database.
  • Manage and motivate study teams to enrollment goals.
  • Participate in Community Outreach events as appropriate.
• Quality Assurance and Regulatory Management
  • Oversee the preparation and submission of regulatory materials to sponsors and oversight organizations.
  • Coordinate approval of materials developed or modified at the site by sponsoring or managing organizations.
  • Coordinate approval of materials by Institutional Review Boards (IRBs) and other outside regulatory organizations.
  • Ensure studies are implemented in compliance with Good Clinical Practice (GCP) guidelines as promulgated by the FDA and ICH.
  • Design, implement, and/or oversee the ongoing Quality Assurance program for the site.
  • Develop and maintain complete training files for all staff as outlined in the company’s Standard Operating Procedures.
• Study Operations
  • Contribute to effective management of all aspects of clinical research studies and related office operations.
  • Approve all hires and contractors in consultation with Human Resources and the Director of Operations/Clinical Operations Manager.
  • Oversee Clinical Research Coordinators on training of all staff for study-related procedures.
  • Coordinate centralized support services (e.g., Accounting/Finance, Contracting, Business Development, Quality Assurance).

This role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization.

Requirements

• B.A. or B.S. required; advanced degree preferred.
• Minimum of 3 years’ experience in managing clinical trials.
• Understand regulatory requirements, as well as Good Clinical Practices (GCP), HIPAA, and International Conference on Harmonization (ICH) guidelines.
• Excellent communication skills (interpersonal, written, verbal).
• Ability to perform overnight business travel.
• Good organizational and interpersonal skills.
• Attention to detail.
• Excellent computer skills to include Word, Excel, PowerPoint, as well as proprietary applications unique to the clinical research industry (such as Study Manager).
• Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.
• Knowledgeable in medical terminology to communicate with physician offices, pharmacists, and laboratory staff.
• Able to manage a staff of clinical professionals and create a productive, satisfying work environment.
• Demonstrate the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.