Site Director
3 weeks ago
Site Director
The Site Director will ensure study enrollment to meet or exceed Sponsors' expectations, and company goals are achieved on a timely basis. The site director will also ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations and ICH/GCP guidelines and to provide the best quality data to the sponsor.
DUTIES & RESPONSIBILITIES
- Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis.
- Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents and assigned study protocol(s).
- Responsible for immediate supervision and performance of the assigned site staff.
- Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include, but is not limited to:
- sponsor provided and IRB approved Protocol Training
- All relevant Protocol Amendments Training, any study specific Manuals Training as applicable
- Sponsor-specified EDC and/or IVRS
- Any other relevant Electronic Systems training.
- It is the responsibility of the Site Director to make sure all the relevant training is completed prior to performing any applicable tasks on the assigned study.
- Working knowledge of the recruitment and relevant cross functional departmental processes for their assigned protocol(s) at their respective site(s).
- Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate as well as timely follow up on the action items, at their respective sites.
- Making sure that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study related documents are utilized and implemented at all times for the assigned protocol(s) at their respective site(s).
- Working with the Regulatory Team to ensure maintenance of Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for their assigned protocol(s) at their respective site(s)
- Working with the cross functional team(s) and site team(s) to ensure study start readiness on all the aspects and adequate training completed by all the relevant site staff prior to FPFV.
- Ensuring clinical trial management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs and guidance documents.
- Responsible for providing guidance to the site team on planning and monitoring the conduct of the clinical trials.
- Accomplishing site objectives by managing staff; facilitating staff training as applicable; communicating job expectations
- Coaching, counseling and disciplining the employees as applicable.
- Collaborating with both internal and external cross-functional stakeholders for the successful conduct and management of assigned protocol(s) at their respective sites.
- To develop, coordinate, and enforce site specific systems, policies, procedures, and productivity standards.
- Communicating and effective implementation of strategic goals from senior management
- Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).
- Striving to ensure weekly, monthly and quarterly assigned goals are met for their respective site(s).
- Being prepared for and available at all required company meetings.
- Submitting required administrative paperwork per company timelines.
- Occasionally attending out-of-town Investigator Meetings.
- Any other matters as assigned by management.
KNOWLEDGE & EXPERIENCE
Education:
- Bachelor’s Degree in a field of Medicine, Science, Behavioral Science, Nursing, or related field required
- Masters degree preferred
- 5-7 years experience in a managing high growth clinical research sites required
- 3+ years in multi study management required
- 3+ years in team management required
Credentials:
- ACRP- PM, ACRP-CP or equivalent preferred
Knowledge and Skills:
- Excellent communication, organizational and problem-solving skills
- Strong skills with MS Office and/or Google Suite
- Expertise in Trial management and ICH-GCP guidelines and FDA Clinical Trial Guidelines
- Strong attention to detail
- Strong skills in multi-tasking and delegating tasks
- Strong People Management skills
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