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Clinical Research PhysicianJob ID 74210BR Baltimore, Maryland
|Provide medical consultation and physician research services as Principle Investigator/Sub Investigator for clinical trials conducted at the Parexel Baltimore Early Phase Unit. 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 at the PAREXEL. |
•Execute all appropriate Investigator responsibilities on assigned projects.
•Support the implementation and application of ClinBase™ in the EPCU.
•Support Standard Operating Procedures (SOPs), Good Clinical Practices, and all work processes to ensure the efficient and compliant clinical operation of the EPCU.
•Assist with the medical and clinical oversight of all aspects of function and work performed within the EPCU.
•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 the review and coding of adverse events and concomitant medications for accuracy and consistency.
•Provides medical consultation as required or requested by the client/sponsor or the PAREXEL-Baltimore EPCU staff.
•Provides support for the preparation of clinical protocols, integrated clinical and statistical summary reports, and other documents as requested.
•Participate in on-call and general physician coverage schedule for the EPCU.
•Establish working relationships with client representatives, promoting confidence and reliability regarding the EPCU’s operations. Represents PAREXEL-Baltimore EPCU to clients in a positive and professional manner. Provide support for marketing activities as requested.
•Liaise with sponsors on study conduct and study progression 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.
QualificationsJob qualifications include:
- MD in the State of Maryland, or willing to obtain license in Maryland
- Early Phase experience preferred, but not required
- Previous management experience a PLUS
- Strong clinical and ethical problem solving
- Open to Physicians seeking to make a change from Clinical Practice to Research
EEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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