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Medical Director

Company: Paradigm Clinical Research Center
Location: La Mesa
Posted on: September 16, 2022

Job Description:

Full-time $220,000 - $250,000 a year 1 day ago Health insurance Employee assistance program Paid time off Qualifications Clinical trials BC/BE Medical License Full Job Description PARADIGM CLINICAL RESEARCH JOB DESCRIPTION MEDICAL DIRECTOR REPORTS TO CHIEF EXECUTIVE OFFICER KEY FUNCTIONS AND RESPONSIBILITIES The Medical Director is a critical member of the senior leadership team as a physician responsible for providing medical and scientific guidance, management and strategic direction related to the Company's current and future participation in clinical trials. The Medical Director provides direct leadership, management, training, and oversight to other professional medical staff including the Company's external contract Investigators, and the Company's employee Investigators including other physicians and midlevel practitioners. The Medical Director may also act as Principal Investigator and/or Sub-Investigator depending on circumstances. The Medical Director provides medical and scientific expertise and guidance over the lifecycle of studies through close collaboration and cooperation with the Company's Clinical Operations leadership and staff. The Medical Director takes an active role in the Company's growth objectives. The Medical Director supports the development of new client relationships and the strengthening of existing account relationships with a view to expanding the Company's portfolio of investigators, studies, clients and therapeutic area experience and expertise. The Medical Director also assists in building and managing positive relationships in the clinical research community to increase the Company's visibility, reputation, and stature consistent with being a recognized employer and partner of choice. Medical Director's Responsibilities as Principal Investigator (PI) Provide overall medical and scientific review of new clinical study opportunities including protocols in various stages of completeness to assess feasibility, identify potential enrollment and study execution challenges, develop enrollment and study execution strategies, and develop contingency plans all with a view to ensuring conformance with International Conference on Harmonization, Good Clinical Practice (ICH GCP). Provide medical and scientific subject matter expertise during the continuum of the business development activities including from lead generation to study award and the generation of repeat study opportunities. Ensure the safety and well-being of all study participants at PI's site(s). Ensure the rights, integrity, and confidentiality of participants at PI's site(s) are protected. Ensure study data is credible, accurate, complete, legible. Adhere to study protocol to avoid protocol deviations. Assist and train research staff as needed to avoid protocol deviations. Develop and assist in maintaining relevant SOPs, ensure staff are properly trained on relevant SOPs, and ensure training is properly documented. Ensure timeliness of data collection and reporting consistent with source documents. Comprehensive understanding of the informed consent process and protocol so that proper written informed consent from each subject is received prior to participation in the study. Assist, provide guidance and train research and other staff as needed on ICH GCPs. Provide study specific training to research staff including protocol amendments. Participate in investigator meetings and trainings as needed. Provide active, ongoing study oversight sufficient to meet ICH GCP requirements and the expectations of Company clients including sponsors and CROs. Provide active, ongoing engagement in study to ensure enrollment commitments, goals and expectations are met or exceeded. Perform physical assessments and other study procedures required by the PI as outlined in the schedule of events. Report Serious Adverse Events (SAEs) (and similar events as required), including events affecting participants' safety to sponsors and appropriate regulatory body(ies) per reporting guidelines. Actively participate in monitoring visits, audits and other meetings as needed. Ensure monitors, auditors and inspectors receive prompt and complete responses to requests for documentation, data, etc. and provide access to study-related records as requested. Ensure study documentation, including but not limited to, informed consent forms, recruitment materials and promotional copy are IRB approved and comply with GCP and other applicable regulatory requirements. Be thoroughly familiar with the appropriate use of the investigational product (study drug) as described in the protocol and Investigator's brochure/product monograph and other documents provided by the sponsor. Stay current and comply with ICH GCPs and all other applicable regulatory requirements. Ensure participants are appropriately informed and receive appropriate therapy and follow-up should a study terminate prematurely or be suspended. Provide detailed written explanation to sponsor and IRB should the PI terminate participation in the study without prior agreement from the sponsor. Identify and assist in building relationships with medical practices, pharmacies, and other health care professionals/organizations to aid in patient recruitment. Support business development activities as appropriate. Share best practices across the Company's employee base as well as with other PIs and Sub-Is. All other PI duties as assigned or required by study protocol, regulatory agencies, sponsor or CRO. Medical Director's Responsibilities as Sub-Investigator Ensure PI provides sufficient oversight to meet ICH GCP requirements and the expectations of Company's clients including sponsors and CROs. Ensure PI conducts study related activities and procedures as required of the PI according to ICH GCPs and sponsor requirements. Ensure enrollment expectations and commitments are met or exceeded. Participate in clinical studies according to ICH GCPs for sub-Investigators, ensuring adequate time and resources are available, as described in study protocols. Clinically evaluate study participants, answer their medical questions, and resolve medical issues, related to the clinical trial during study visits. Maintain records of each subject's participation, which includes a review of participants' past and current medical records, to be compared with visit medical history, concomitant medication and protocol inclusion and exclusion criteria. Determine participant's eligibility for the study. Assess subjects' response to therapy and subject compliance with use of the study drug at follow-up visits Evaluate treatment of subjects for adverse events and reporting of all such events to the PI. Monitor use of concomitant therapy as authorized by the study protocol. Ensure that study drugs and devices are used for protocol purposes only. Provide leadership in identifying new clinical trials and assist in initiation of new trials. Play an active role in the recruitment of patients to designated studies, while ensuring that subject recruitment is conducted ethically and efficiently. Participate in pre-screening recruitment initiatives and activities for clinical trials participants, including presentations to healthcare professionals, public screening clinics, etc., as required. Comprehensive understanding of the informed consent process and protocol so that proper written informed consent from each subject is received prior to participation in the study. Actively participate in audits and monitoring visits. Completion of all administrative tasks for patient files according to ICH GCP guidelines and best clinical practice. All other Sub-I duties as assigned or required by study protocol, regulatory agencies, sponsor or CRO. Job Type: Full-time Pay: $220,000.00 - $250,000.00 per year 401(k) Employee assistance program Health insurance Paid time off Vision insurance Schedule: 8 hour shift Supplemental pay types: Ability to commute/relocate: La Mesa, CA 91942: Reliably commute or planning to relocate before starting work (Required)

Keywords: Paradigm Clinical Research Center, La Mesa , Medical Director, Executive , La Mesa, California

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