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Clinical Research Clinician

Pfizer


Location:
New Haven, CT
Date:
12/01/2017
2017-12-012018-01-01
Pfizer
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Job Details

**SUMMARY:**



Serves as an Investigator/Research Clinician at the Pfizer New Haven Clinical Research Unit.



Operates independently to provide medical support as a functional expert for all research activities conducted in the Phase I Unit. Responsible for a lead role in the management of study subjects. Serve as Physician extender for medical coverage model.



Confers with clinic physicians as necessary and ensures they are apprised of medical activities and decisions. Reviews clinical laboratory results and medical information and determines follow-up procedures as necessary (sign-off authority).



Assures subject safety and the accurate evaluation of products by assisting in the design, implementation, reporting, and summarization of clinical trials conducted in the Pfizer Research Clinic/Phase I Unit







**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:**



An advanced practioner degree is required (APRN or PA). CT license to practice medicine within the scope of practice defined by the state of CT (or clearly be able to obtain CT license). Must have knowledge of FDA



regulated drug development process. Excellent interpersonal skills, detail oriented, with ability to work in a fast-paced environment. Clinical experience of at least 2 years.







**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.







**Sunshine Act**



Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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