- Medical License
- FDA Regulations
Provide medical consultation and physician research services for studies as needed. Responsible for presentation of medical functions and services to clients/sponsors as requested. Ensure timelines and quality of work performed by the clinical operations staff
Execute all appropriate Investigator responsibilities on assigned projects.
Support Standard Operating Procedures (SOPs), Good Clinical Practices, and all work processes to ensure the efficient and compliant clinical operation of the CPRU.
Assist with the medical and clinical oversight of all aspects of function and work performed within the CPRU.
Assist with training and input on performance assessments for clinical operations personnel.
Work directly with clinical operations personnel in reviewing laboratory data, performing physical assessments, medical histories, and evaluation of inclusion/exclusion criteria for study participants.
Participate in on-call and general physician coverage schedule for the CPRU.
Support the implementation and application of ClinBase in the CPRU.
Liaise with sponsors on study conduct and study progression as requested.
Provides medical consultation as required or requested by the client/sponsor or the CPRU staff.
Participate in the review and coding of adverse events and concomitant medications for accuracy and consistency.
Provides support for the preparation of clinical protocols, integrated clinical and statistical summary reports, and other documents as requested.
Establish working relationships with client representatives, promoting confidence and reliability regarding the CPRU's operations. Represents Provide support for marketing activities as requested.
Liaise with physician staff of MedStar Health and local/regional medical consultants as necessary.
Participates in the review of source data and/or data listings of safety data, including adverse experiences, laboratory data, and vital signs data to establish the presence or absence of abnormal trends, and if noted, follow-up as appropriate with the clinical team, project team sponsor, investigator and regulatory agencies.
Participates in the review of individual adverse experience reports for accuracy and clinical importance, and characterize their relationship to the study drug, severity and seriousness. Provide reports to FDA or other regulatory agencies and the sponsor on a periodic and regular basis summarizing adverse experiences as required by the FDA or the sponsor as needed.
Ensures that all established timelines relating to areas of responsibility and assigned projects are met.
Ensures that the quality standard of clinical work product is met.
Any other duties as assigned by immediate supervisor.
Excellent interpersonal skills.
Detailed oriented with the ability to work in a fast paced environment.
MD or DO
Minimum Work Experience
Clinical practice experience of at least two years and board certification in general medical specialty preferred, or other equivalent experience.
Clinical or pharmaceutical research experience desirable.
Ability to obtain and maintain an unrestricted license to practice medicine in the state of Maryland.
Knowledge of the FDA regulated drug development process is helpful.