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Clinical Research physician
4 months ago
Our client, a world-leading Pharmaceutical Company in New Haven, CT is currently looking for a Clinical Trials Physician to join their expanding team.
Job Title: Clinical Trials Physician / Pharma Industry
Duration: 10 months contract, extendable up to 36 months
Location: New Haven, CT
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Clinical Research Physician
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 accountabilities 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.
Responsibilities:
Assumes accountability for all medico-legal, scientific integrity, human safety and medical governance aspects of PCRU studies
Liaises with other Pharmaceutical 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
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 Pharmaceutical 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
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 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.
Represents the PCRU on company-wide initiatives in their area(s) of expertise
Represents Pharmaceutical 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)
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 Pharmaceutical 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:
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 is 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
A minimum of 2+ 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
Location:
This is a fully onsite role in New Haven, CT
