Clinical Research Physician - #19528379
Serves as Investigator at the CRU
- Accountable for safety, scientific integrity, medico legal and medical governance aspects of assigned clinical studies.
- Liaises with relevant Pfizer sites regarding the design, conduct and progression of studies conducted at the Clinical Research Unit.
- Supports Standard Operating Procedures (SOPs), Good Clinical Practices, and all work processes to ensure the efficient and compliant clinical operation of the CRU.
- Assists with the medical and clinical oversight of all aspects of function and work associated with the CRU.
- Assists with training and provides medical input for clinical research personnel.
- Works directly with clinical research personnel, reviewing lab data, performing physical assessments, obtaining medical histories, and evaluating inclusion/exclusion criteria for study volunteers.
- Participates in on-call and general physician coverage schedule for the CRU.
- Supports the implementation and application of PIMS in the CRU.
- Liaises with Yale University School of Medicine staff and necessary.
- Participates 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.
- Liaises with local/regional medical consultants as necessary.
- Participates in the review of source data and/or data listings of safety data, including adverse experiences, lab data, and vital signs data, to establish the presence or absence of abnormal trends, or if noted, follow-up as appropriate with the CRU clinical team, the CRU project team, the sponsoring Pfizer site, and regulatory agencies.
- Participates in the review of individual adverse event reports for accuracy and clinical importance, and characterizes their relationship to the study drug, severity and seriousness.
- Assists as necessary with IRB submissions.
- Authors safety sections of Informed Consent documents, and assists in obtaining the consent from study volunteers.
QUALIFICATIONS / SKILLS
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
- An MD or DO is required. Completed an accredited residency program, preferably in internal or emergency medicine unless CRU medical specialty dictates otherwise.
- Board eligible or certified. Must have (or clearly be able to obtain) an unrestricted license to practice medicine in the state of Connecticut and successfully complete a standard medical credentialing process.
- Must have knowledge of the FDA drug development process.
- Excellent interpersonal skills, detail oriented, with ability to work in a fast-paced environment.
- Fellowship training (beyond residency) in clinical pharmacology, clinical investigation, translational medicine and/or subspecialty (with clinical research emphasis) preferred.
- Knowledge of FDA regulated drug development process is helpful.
- Clinical practice experience of at least two years and board certification in a general medical specialty preferred, or other equivalent experience.
- Clinical Research Unit experience is desirable as is or pharmaceutical research experience.
- Must have ability to review and understand emerging safety and efficacy profile of a drug candidate and recognize potential serious adverse effects.
- Ability to align clinical skill sets with protocol requirements to assure appropriate staffing for studies.
- Must demonstrate understanding of the complexities and recent developments in exploratory research, and understand clinical pharmacology issues.
- Must have working knowledge of computers and laboratory data handling acquisition system and associated issues/risks.
Other Job Details:
- Eligible for Relocation Package: YES
- Eligible for Employee Referral Bonus: YES
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EEO & Employment Eligibility
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