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Site Director - Clinical Trials Research
Fieve Clinical Research, Inc
- Clinical Operations
The Site Director is responsible for the profitable management of the clinical research business, consistent with company Standard Operating Procedures, principles, strategies and objectives; and is accountable for overall coordination, organization, and efficient implementation of clinical trials marketing, operations, and regulatory compliance. The position requires diverse managerial and marketing responsibilities requiring considerable analysis, judgment, and detailed understanding of clinical research processes, as well as clinical study coordination as needed.
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 Manager is guided by Good Clinical Practices (GCP), International Committee on Harmonization (ICH) guidelines, and company standard operating procedures and policies.
Job Duties and Responsibilities:
Under supervision of the President, the duties and responsibilities will include but are not limited to:
Study Operations: Manages all aspects of clinical research studies and related office operations.
- Hires, trains, and manages Clinical Research Coordinators, Assistant Clinical Research Coordinators, Lab Technicians, Patient Recruitment Coordinators, and Interns.
- Manages other clinical and administrative staff and contractors (i.e. Sub-Investigators, specialists etc.).
- Coordinates and provides of needed support services (e.g. accounting, human resources, facilities management, etc.).
- Manages the processes of subject recruitment, appointment scheduling, informed consent, subject visits, source document preparation, Case Report Form/Electronic Data Capture and other document preparation and disposition, and regulatory documentation and reporting.
- Perform CRC duties/responsibilities, as needed including (but not limited to) performing all aspects of subject visit (i.e. obtaining ICF, administering rating scales, collecting/shipping labs and ECGs, subject drug accountability, etc.), site monitor visits, data entry, etc.
- Oversee coordination of Investigator/sponsor meetings, and preparation/follow-up of site monitor visits.
Subject Recruitment: Develops and implements a plan for recruiting subjects into each study.
- Identifies media to be used for patient recruitment (e.g. newspaper, radio, telemarketing, etc.).
- Implements selected communications strategies (e.g. generating mailing lists, writing advertising copy, Institutional Review Boards (IRBs)/sponsor approvals).
- Secures funding and payments for study related advertising (e.g. requesting invoices from media vendor, submitting invoice to sponsor for payment/reimbursement, etc.).
Regulatory Review and Management: Manages the preparation and submission of regulatory materials to sponsors/CRO and IRB.
- Coordinates approval of materials developed or modified at site by sponsor/CRO, IRBs or other regulatory organizations, as required.
- Ensures that studies are implemented in compliance with Good Clinical Practice (GCP) guidelines as promulgated by the Food and Drug Administration (FDA) and the International Conference of Harmonization (ICH).
Sales and Marketing: Develops and implements a sales and marketing plan for cultivating relationships with clinical trial sponsors (e.g. pharmaceutical/biotechnology companies) and Contract Research Organizations (CROs), and for participating profitably in clinical trials sponsored and/or managed by those companies.
- Develops a sales and marketing plan for clinical research services.
- Develops promotional materials for marketing clinical research services.
- Generates leads (via cold calls, networking, research, etc.) and follows-up with potential sponsors.
- 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 and Site Director.
- 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.
Planning and Management : Assist in the development and implementation of Standard Operating Procedures (SOPs) for achieving the strategic and tactical goals of the company.
- Develops, updates and implement SOPs, annually and as needed.
- Manage staff members including (but on limited to) CRC(s), Lab Tech, Sub-Investigator(s) to ensure that all clinical and regulatory responsibilities are met and that protocol guidelines are strictly adhered to.
- Management of staff members on a daily basis to ensure harmony among the team members while ensuring that duties and responsibilities are met in timely fashion.
- Coordinate weekly team meetings.
- Oversee staff to ensure that deadlines and weekly/monthly goals are met and report status of these goals as well as status of overall clinical operations to the Site Director using weekly/monthly reports.
B.A. or B.S. required, advanced degree preferred; minimum of 3 years progressive experience in managing clinical trials.
Training/Experience Clinical Requirements:
- At least 3-4 years prior experience in clinical research preferred.
- Proficient in clinical research requirements: Familiar with clinical research study processes and requirements. Knowledgeable in 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, professional and courteous manner. Knowledgeable in medical terminology so as to communicate with physician office and laboratory staff.
- 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 propriety applications unique to the clinical research industry and individual sponsoring organizations.
- Travel: Able to travel up to 20% to attend sponsor and industry meetings.
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