Location: Remote
Organization: WCG IRB
Job Type: Full Time - Regular
Description and Requirements
ABOUT WCG:
WCG’s clinical solutions are built on a foundation of best-in-class clinical services companies. We deliver transformational solutions that stimulate growth, foster compliance, and maximize efficiency for those performing clinical trials. WCG is proud to serve individuals on the frontlines of science and medicine, and the organizations striving to develop new products and therapies to improve the quality of human health. It is our role to empower them to accelerate advancement, while ensuring the risks of progress never outweigh the value of human life.
WHY WE LOVE WCG:
At WCG, our employees are our most valuable asset and as with all our assets, we invest in them with an eye toward future success. We provide each eligible employee with a comprehensive set of benefits designed to protect their personal and financial health and to help them make the most of their future.
* 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, and sick time
* Opportunities for career development with on-the-job training, certification assistance and continuing education reimbursement
The expected base salary range for this position is $138,870 to $275,000. This salary range may vary based on the candidate's qualifications, experience, skills, education, and geographic location.
JOB SUMMARY:
Provide the highest possible support as a subject matter expert (SME) to WCG’s ethical review and research safety programs in areas and issues requiring medical training and judgment. This most commonly involves the Institutional Review Board, WCG clients and may also include providing ethical advice to other WCG divisions
ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The accountabilities listed below are representative of the knowledge, skills, and/or ability required.
- Chair Board meetings to ensure compliance with federal and state laws and WCG policies and procedures and facilitate discussion from Board Members. Provide medical, scientific, ethical and legal support and advice to Board members as appropriate based on educational background and experience.
- Analyze research submissions, identify problems and issues, collect additional information or request corrections, and draft memoranda with assistance.
- Review research submissions and make recommendations regarding the best medical, ethical and regulatory decisions to the IRB, WCG Staff, and Clients
- Prepare and deliver training as needed to Board members, outside clients, institutions, and other parties involved in human subject research.
- Analyze and perform the scientific review of protocols and other agenda items at Board meetings to facilitate informed decision making, and to set standards and role model effective presentation and discussion for all Board members.
- Contribute to internal thought-leadership in human subject protection through written materials (blog posts, white papers) and presentation at internal meetings and training events, alone or in collaboration with colleagues.
- Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
- Attendance and punctuality are essential functions of the position.
EDUCATION REQUIREMENTS:
- Bachelor’s degree and Medical degree (M.D. D.O) and 6 years’ experience in a relevant role
- Relevant experience or education may substitute for requirements. Prior experience in clinical research with a focus on ethics, preferred
CERTIFICATIONS/LICENSE/REGISTRATION REQUIREMENTS:
- Must commit to passing the CIP exam within 2 years of reaching the minimum qualification of 2 years with an IRB. Maintain CIP certification once obtained
QUALIFICATIONS/EXPERIENCE:
- Ability to read, analyze, and interpret common scientific and technical journals, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the community. Ability to write presentations and articles for publication that conform to prescribed style and format. Ability to effectively present information
- Familiarity with mathematical concepts such as probability and statistical inference. Familiarity with concepts such as common statistical tests, correlation, confidence intervals, and survival curves in discussing the design and interpretation of human subject research
- Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with a variety of abstract and concrete variables
- Ability to utilize computers effectively for performance of common office functions. Knowledge of MSWord, MS Excel, MS Outlook and MS Windows
SUPERVISORY RESPONSIBILITIES: NA
TRAVEL REQUIREMENTS:
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