Job Description

Serves as Investigator at the CRU

RESPONSIBILITIES:

* 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

LI-PFE

Sunshine Act

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EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Medical

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