The Physician Investigator at TRGI’s Clinical Research Unit (CRU) will be responsible for winning new business, subject recruitment and the overall conduct of the clinical trials conducted at the CRU. He or she will be fully supported by operational an
Translational Research Group, Inc. has operated a successful community-based clinical research center in Burbank/North Hollywood for over 17 years. We conduct outpatient and early phase in-indication studies and additionally provide niche contract research services to biopharmaceutical and medical industry clients.
Due to continued growth and exciting new collaborations, we are expanding to additional locations and seek a Clinical Research Physician to direct our established North Hollywood location and serve as principal investigator on established and new clinical research studies.
TRGI is privately owned by physicians who foster a corporate culture with a high degree of professionalism, a relaxed atmosphere and great team spirit. We are family friendly, low on bureaucracy and do not deal with third party payers. Our quality of life is exceptionally high. The tradeoff for this quality of life is that you need to be a self-starter, entrepreneurial, a great manager, and detail oriented with great interpersonal skills.
The Physician Investigator at TRGI’s Clinical Research Unit (CRU) will be responsible for winning new business, subject recruitment and the overall conduct of the clinical trials conducted at the CRU. He or she will be fully supported by operational and support staff on the Unit. In addition, the Physician Investigator may provide critical feedback on informed consents, protocol designs, clinical data summaries, data and safety monitoring plans and other study-specific documents. The Physician Investigator will assign team members to each project and will work closely with the director of clinical operations, nurse practitioner, physician assistant, registered nurses and sub-specialist sub-investigators. In this unique position you will also interact with various sponsor, CRO and IRB personnel to ensure the health and welfare of study participants and the compliance with study protocols.
Essential Duties and Responsibilities:
· Responsible for protecting the rights, safety and welfare of study participants.
· Responsible for ensuring that the clinical trial is conducted according to the investigational plan, ICH GCP guidelines and all applicable regulations, including efficient recruitment of subjects.
· Provide medical and scientific feasibility of all new sponsor inquiries.
· Provide, in collaboration with operational/clinical team, feasibility assessments of all new, applicable sponsor projects
· Review and evaluate protocols and provide clinical and scientific support.
· Liaise with sponsor regarding study design and site capabilities.
· Interact with regulatory bodies as relevant to clinical operations.
· Attend study initiation meetings.
· Complete all sponsor-provided general and protocol trainings.
· Submit protocols and site applications to IRBs, adequate to obtain approval
· Train staff on medical aspects of study protocols.
· Assist clinical operations, quality assurance and business development efforts with sponsor visits.
· Assist during site audits (sponsor, CRO, FDA or other) for relevant studies
· Perform pre-study physical examinations, review lab data, ECGs and other medical information to ensure volunteers are appropriate for studies.
· Perform all protocol-required physical examinations and other medical assessments to evaluate the physical and mental wellbeing of participants and act in the best interest of study participants.
· Inform IRB and Sponsor in a timely manner of all reportable events.
· Review and sign CRFs/eCRFs to attest to the accuracy of content at the conclusion of the study.
· Delegate the above as appropriate to individuals qualified by education, experience and training to perform the tasks assigned.
· Work evening, weekend and off-hours work as necessary.
· Take evening, weekend and off-hours call as necessary.
· Maintain medical licensure and certification throughout employment.
· Maintain good standing with the Medical Board of California, FDA and all bodies that govern the practice of medicine and conduct of clinical research.
• M.D. or D.O. with active license to practice medicine in the state of California
• Active U.S. Board Certification/DEA license and ideally ACRP certification
• Prior experience as a principal investigator with excellent performance is mandatory
• Exceptional clinical and communication skills
• No prior sanctions by a state licensing agency; not disqualified from or restricted in the participation of clinical research by FDA
• Strong interpersonal and leadership skills, self-motivation, and high personal integrity and ethics required
The Statements made in the job description are intended to describe the general nature and level of work being performed by people assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job.
TRGI management has the discretion to hire personnel with a combination of experience and education which may vary from the above listed skills and qualifications.