The posting
ROLE SUMMARY
The Clinical Research Clinician will act as an Investigator and/or Principal Investigator for clinical trials conducted in the Pfizer Clinical Research Unit (PCRU) and has responsibilities and accountabilities for trial oversight involving all clinical and medical aspects of study conduct. The Clinical Research Clinician operates independently to provide medical support, confers with clinic physicians as necessary and ensures they are apprised of medical activities and decisions providing 24/7 safety coverage of study participants.
ROLE RESPONSIBILITIES
As an Investigator:
- Assumes accountability for all medico-legal scientific integrity, human safety and medical governance aspects of assigned clinical studies.
- Liaises with relevant Pfizer sites regarding the design, conduct and progression of studies conducted in the PCRU.
- Assists with the medical and clinical oversight of all aspects of function and work associated with the PCRU.
- Participates in the planning, execution and data review for allocated studies.
- Works directly with clinical research personnel, reviewing lab data, performing physical assessments, obtaining medical histories, and evaluating inclusion/exclusion criteria for study participants.
- Participates actively in the review/correction/update and approval of study data, especially the review and coding of adverse events and concomitant medications for accuracy and consistency.
- Supports the development of Informed Consent Documents for allocated studies and assists in obtaining consent from study participants.
As a Principal Investigator:
- Assumes accountability and responsibility for the execution of the allocated clinical trials.
- Facilitates and coordinates the conduct of Phase I-IIa-IV studies, including Early Development and Full Development Clinical Pharmacology studies (protocol development, review, regulatory and IEC submissions).
- Provides support for the preparation of clinical protocols, integrated clinical and statistical summary reports, and other documents as requested.
- 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 PCRU clinical team, the PCRU project team, the sponsoring Pfizer site, and regulatory agencies.
- Participates in the review of concomitant medication and individual adverse event reports for accuracy and clinical importance, and characterizes their relationship to the study drug, severity and seriousness.
- 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.
Other
- Develops a good working knowledge of study management and a full understanding of ICH-Good Clinical Practice and Pfizer SOPs, Work instructions and Guidances.
- Develops a good working knowledge of clinical trial activities within the industry and passes this on to less experienced staff.
- Liaises with University Hospitals as necessary in their areas of expertise and joint projects.
- Develops productive working relationships with hospital colleagues and with colleagues at the PCRU and at other Pfizer sites to facilitate the performance of the duties and continued development as a Clinical Research Investigator.
- Develops familiarity with the practice of pharmaceutical medicine through the literature and by attending appropriate trainings, meetings and conferences.
- Liaises effectively with all members of the PCRU and makes a positive contribution towards team spirit in the PCRU.
- Performs regular On-Call/Duty tasks to ensure continuous medical/clinical coverage supporting the conduct of clinical trials in the PCRU.
- Additional responsibilities after acquisition of relevant experience in Phase 1 clinical research activities.
- Represents the PCRU on company-wide initiatives in their area(s) of expertise.
- Represents Pfizer in external environments (e.g., scientific meetings, advisory meetings, etc.) in their area(s) of expertise.
- Develops, maintains and shares subject matter expertise on Clinical Pharmacology and/or Biomarker Methodology topics and studies.
- Act as the expert Clinician in Phase 1 clinical research for Worldwide Research and Development, Global Product Development, Clinical Development and Operations, and participates on/contributes to global clinical research committees (e.g. CPSDC).
Training
- Participates in training courses related to clinical research, pharmaceutical medicine, pharmacology as appropriate.
- Assists or acts as a preceptor in the training of PCRU staff and contractors with less experience and expertise
- Develops knowledge to be responsible for compliance with Pfizer Standards, ethical standards, ICH, regulatory and legal requirements, national /state laws on health and safety at work, fire prevention and other appropriate legislation.
BASIC QUALIFICATIONS
- An advanced practitioner degree is required (APRN). CT license to practice medicine within the scope of practice defined by the state of CT (or clearly be able to obtain CT license).
- BLS Certification required.
- Clinical experience of at least 2 years required.
- Excellent interpersonal skills, detail oriented, with ability to work in a fast-paced environment.
- Knowledge of FDA regulated drug development process is an asset.
- 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.
PHYSICAL/MENTAL REQUIREMENTS
Manual skills: significant portions of daily assignments involve application of manual skills requiring motor coordination with finger dexterity.
Physical effort: duties involve light effort.
Work involves up to 5 pounds of force to lift, carry, push, pull or move objects.
Work Location Assignment: On Premise
Other Job Details:
Serves as a contributor to the on call-schedule to maintain 24/7 unit coverage.
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.
The annual base salary for this position ranges from $139,100.00 to $231,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
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.
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. This position requires permanent work authorization in the United States.
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