Clinical Research Clinician, Associate Director

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

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