Job posting has expired

Executive Physician-WCG (Remote)

WIRB - Copernicus Group
paid time off, sick time, tuition reimbursement, 401(k)
United States, Princeton
212 Carnegie Center Drive (Show on map)
May 02, 2023
JOB SUMMARY: The Executive Physician is an integral part of WCG's Review Solutions subject matter expert team, including providing direct support to Institutional Review Board services in balancing the needs of human clinical trial participants, sponsors, and institutions while providing insights and guidance to research operations. The Executive Physician contributes to the provision of high-quality, timely reviews that operate in accordance with all applicable regulatory standards that enable a study moving into the clinic and delivering new therapeutics and diagnostics to patients faster. The Executive Physician operates at the intersection of medicine, research and regulations, and as such is highly trained and highly knowledgeable in all aspects of protocol review. The Executive Physician contributes deep subject matter expertise and operational guidance on full Board and expedited reviews, working alongside the IRB to provide the necessary support to ensure high-quality, timely reviews, in which ethical issues are thoroughly considered, and that research will be conducted to the highest standards. EDUCATION REQUIREMENTS: MD or DO degree, including post-graduate training BENEFICIAL BUT NOT REQUIRED: CIP certification Experience and regular interaction with industry organizations and working groups including PRIM&R, MRCT, AEREO, SACHRP Formal training (certificate, graduate degree) in bioethics QUALIFICATIONS/EXPERIENCE: At least 10 years of clinical research experience, including significant experience in a leadership role Experience, preferably at the leadership level, in an Institutional Review Board/ Human Research Protection Program Excellent verbal and written communications skills (e.g., presentations) High level of fluency with CFR 312, 812, ICH/ FDA GCP and other relevant regulations and guidance governing human subjects research ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required. Contribute as a member of the IRB Executive Committee to the development of policies, practices and training content applicable to and utilized by WCG IRB Boards and Board members Lead the planning and conduct of Board member training on current research issues and research-related regulations, including ongoing training as well as spring and fall training events Work with QA/compliance to develop/update/enhance SOPs and policies as appropriate Respond to questions from and/provide guidance and/or interpretation to IRB Chairs, researchers, sponsors and other parties engaged in IRB review and the application of regulations Provide consultation to researchers, institutions and sponsors related to research determinations, ethical policies or research practices Participate in meetings with IRB Operations to contribute subject matter expertise as appropriate and/or applicable Provide internal and external thought-leadership on matters pertaining to protocol review operations and IRBs Participate in thought-leadership efforts including webinars, the development of white papers and blog posts, interviews with journalists as requested by Marketing Participate in industry conferences including presentation and panels, industry working groups (AEREO, MRCT), and other industry efforts related to clinical research conduct Provide guidance and mentoring to IRB Chairs and other IRB Affairs staff in developing thought-leadership skills Support Business Development by responding to current and potential client questions, explain applicable regulations and provide subject matter expertise to develop client solutions Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here. TRAVEL REQUIREMENTS: 5% - 10% PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to perform sedentary work which includes sitting for long periods of time and occasionally required to lift 25lbs (11.3 kg). Further guidance on physical activities, requirements, visual acuity, and working conditions is available in HCM. COMPENSATION: Expected annual base salary range: $147,000 to $295,000 Comprehensive Benefits package - Health, Dental, Vision, Life, Disability, 401K with match, and flexible spending accounts Employee Assistance Programs and additional work/life resources Referral Bonuses and Tuition Reimbursement Paid time off including holidays, vacation, volunteer and sick time Opportunities for career development with on-the-job training, certification assistance and continuing education reimbursement Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Position Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. #LI-TF1 #LI-remote