The Site Director will be responsible for the profitable management of the clinical research business, consistent with company principles, strategies, and objectives. Accountable for the overall coordination, organization, and efficient implementation of clinical trials. Performs diverse managerial and marketing responsibilities requiring considerable analysis, judgment, and detailed understanding of clinical research processes. Works closely with the Principal Investigator 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, and company standard operating procedures and policies.
Responsibilities may include but are not limited to:
Develops and implements business plans for achieving the strategic and tactical goals and objectives of the line of business.
Identifies and pursues market expansion opportunities
Oversees the financial performance of the line of business
Assists Senior Management in identifying new business opportunities in the sector
Reviews staffing models and schedules.
Manages all aspects of clinical research studies and related office operations.
Manages the processes of appointment scheduling, informed consent, subject visits, source document, Case Report Form and other document preparation and disposition.
Collaborates on the sales and marketing plan for clinical research services.
Evaluates study protocols (e.g., with respect to enrollment/retention potential, office capacity and capabilities, profit potential, and other determinants of success), with input from the Principal Investigator.
Coordinates site visits and other communications with sponsoring organizations prior to study implementation, and works through Clinical Research Coordinators to provide ongoing coordination of sponsor communications thereafter.
Collaborates on business arrangements, budgets, and contracts with potential sponsors.
Determines, along with the Principal Investigator, which studies to pursue.
Assists with the development and implementation of plans for recruiting subjects into each study.
Assists and communicates with the regulatory department who prepare and submit regulatory materials to sponsors and oversight organizations.
B.A. or B.S. required
At least 2-3 years prior experience in clinical research preferred
Experience with Finance, Operations, and Clinical Trial Management
Understanding of Clinical Research Requirements: Familiar with clinical research study processes and requirements. Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines.
Thoroughness and Accuracy: Able to collect, organize, interpret, and record detailed information as required by study sponsors and regulatory and review agencies.
Communication: Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner. Knowledgeable in medical terminology so as to communicate with physician office and laboratory staff. Skilled in persuading potential sponsors to place research with the site.
Management: Able to manage a staff of clinical professionals and create a productive, satisfying work environment.
Independence: Demonstrates the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, this job description, and company policy.
Adaptability: Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change.
Computer Skills: Able to use standard office software, as well as proprietary applications unique to the clinical research industry and individual sponsoring organizations.
Compensation is competitive with the ability to profit share.