Job Summary: The Medical Director assumes site responsibility other than those responsibilities specifically intended for the PI. This role ensures adherence to protocol requirements, protects the rights and welfare of participants, assures the integrity of data generated at the site and directs the conduct of the clinical investigation according to federal and state regulations and guidance documents.
Essential Responsibilities and Duties:- Provides medical direction and overall supervision of the medical aspects of the clinical trial site.
- Ensures that safety of study volunteers is not compromised.
- Develops, approves, and implements policies and best practices including continuous quality improvement programs.
- Assists in determining the feasibility of site to execute protocols effectively and efficiently.
- Assists in protocol development when request by sponsor or CRO.
- Monitors and evaluates implementation and effectiveness of quality programs and assessments.
- Ensures that adequate resources are provided for performance of work and assessment activities.
- Attends management reviews, monthly staff meetings, study initiation meetings, monitoring visits, regulatory and sponsor audits as needed.
- Oversees and trains Investigators as needed.
- Provides updates and status reports to owners on a regular basis, report on performance against plan.
- Acts as a liaison for site to external medical providers, the medical community, sponsor, CRO and inspection agencies.
- Reviews clinical trial protocols and make recommendations as necessary.
- Interviews and hires new staff as needed.
- Takes part in communications, support, and provide insight for projects including staffing, timelines and key data issues.
- Hires, trains, supervises, and evaluates personnel. Champions and enforces the strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site Working Practices, protocol, and company guidelines and policies. Retrains and implements corrective and preventative actions, as needed.
- Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.
Education/Experience/Skills:- Must be able to effectively communicate verbally and in writing.
- Licensed MD or Relevant Experience that will translate with Doctorate Degree.
- At least two years of Clinical Trial Management and Oversite required.
- Must be self-directed and able to work with minimal supervision.
- Must have in depth knowledge of FDA regulations.
- Able to take a flexible approach to shifting priorities.
- Able to manage multiple projects and responsibilities.
- Motivated to work consistently in a fast paced and rapidly changing environment.
Working Conditions - Indoor, Office environment.
- Essential physical requirements include sitting, typing, standing, walking.
- Lightly active position, occasional lifting of up to 20 pounds.
- Reporting to work, as scheduled, is essential.
- On site work arrangement.
- Occassional travel.
