Location
New Haven, CT | United States
Job description
Job Description
:
JOB SUMMARY:
Summarize the primary purpose & key accountabilities of the job. The Clinical Research Physician will act as an Investigator and/or Principal Investigator for clinical trials conducted in the PCRU and has responsibilities and accountablites for trial oversight involving all clinical and medical aspects of study conduct. The Clinical Research Physician is a practicing clinician and member of the PCRU team ensuring 24/7 safety coverage of study participants.
JOB
RESPONSIBILITIES:
Key accountabilities:
As an Investigator
- Assumes accountability for all medico-legal, scientific integrity, human safety and medical governance aspects of PCRU studies.
- Liaises with other *** sites/line functions regarding the design, conduct and progression of studies in the PCRU.
- Assists with the medical and clinical oversight of all aspects of function and work performed within the PCRU.
- Participates in the planning, execution and data review for allocated studies.
- Works directly with clinical research personnel in reviewing data, performing physical assessments, medical histories, and evaluation of 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.
- • Supports the implementation and application of electronic health record system (PIMS) in the PCRU.
- Supports the development of Informed Consent Documents for allocated studies and assists in obtaining the 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 *** 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 company's SOPs, Work instructions and Guidance's.
- 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 *** 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.
- Takes part in On-Site Recall duty 24/7 in case of need or urgency.
- 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 *** 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 Physician in Phase 1 clinical research for Worldwide Research and Development, *** Research & 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 in the training of PCRU staff and contractors with less experience and expertise.
- Develops knowledge to be responsible for compliance with *** Standards, ethical standards, ICH, regulatory and legal requirements, national and International laws on health and safety at work, fire prevention and other appropriate legislation.
QUALIFICATIONS / SKILLS: - Medical Degree (MD or DO) with a valid license to practice medicine. Must have, or clearly be able to obtain, an unrestricted license to practice medicine in the state of Connecticut (as applicable to job location), and be able to successfully complete a standard medical credentialing process as may be necessary.
- A post-graduate qualification in a general medical specialty required (Board eligible or Board certified); equivalent experience may be considered.
- Evidence of continuing education/training relative to drug development/study conduct/pharmaceutical medicine is a plus.
- At least 2 to 3 years of independent (e.g. outside of a formal training program) clinical care experience, preferably with part of it in clinical trials.
- Knowledge of local and international drug development regulations (FDA) and process is an asset.
ORGANIZATIONAL RELATIONSHIPS: - Reports to Sr Director, Global Head of PCRU Clinical Operations/Clinical Operations Director
- Networks and collaborates with other *** CRUs to ensure organizational consistency of standard operating procedures.
- Functional relationship to the Clinical Services Director, Business Operations Director, Pharmacy and Regulatory Directors, Medical and Scientific Advisor, and Safety Laboratory Head in areas of safety, ethical and regulatory oversight for study participants.
- Matrixed relationships to study team and other peers in the PCRU (provides guidance for group study management activities), varied *** scientists and clinicians to design protocol, and multiple other colleagues and departments (Dev. Ops., Assay Laboratory, Pharm. Sciences) to implement and report outcomes.
- Operations point of contact for internal departments, external consultants, technical equipment and supply vendors.
- Act as PCRU Representative towards other *** and non-*** departments and customers.
- Collaborates across *** Development and Discovery departments.
- Position Comments visible to MSP and Supplier: Repost 30648
*****Medical Malpractice Insurance is required!*****
- Local to New Haven Site (1hr driving distance) please provide location on appendix-b.
- Takes part in On-Site Recall duty 24/7 in case of need or urgency.
- Act as the expert Physician in Phase 1 clinical research.
- Medical Degree (MD or DO) with a valid license to practice medicine.
- At least 2 to 3 years of independent (e.g. outside of a formal training program) clinical care experience, preferably with part of it in clinical trials.
- Knowledge of local and international drug development regulations (FDA) and process is an asset.
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