SUMMARY OF POSITION: Provide the highest possible support to WCG IRB's ethical review and research safety programs in areas and issues requiring clinical training and judgment.
VACCINATION REQUIREMENT:
To be considered for U.S.-based positions unless currently employed by WCG, where permitted by applicable law (including any applicable reasonable accommodation, medical or religious exemption), candidates must have received or be willing to receive the COVID-19 vaccine by start date.
EDUCATION REQUIREMENTS:
Advanced scientific degree (example: Physician Assistant, Advanced Registered Nurse Practitioner, or Master in Nursing in Clinical Trials Research)
Two or more years of clinical experience
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
QUALIFICATIONS/EXPERIENCE:
Prior experience in clinical research preferred
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 MS Word, MS Excel, MS Outlook and MS Windows.
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.
Provide primary review of safety reports, unanticipated problem reports, subject complaints, site visit and audit reports, and other documents which require review and regulatory determinations, with a clinical context.
Identify problems and issues, collect additional information or request corrections, and draft memoranda or decision justifications as necessary.
When appropriate, present these issues and the clinical context for discussion at board meetings or at staff meetings.
Provide scientific, ethical and regulatory support and advice to Board members and staff.
Research, draft, and present reports to the Board on a wide range of topics, including but not limited to, investigator misconduct, site visits, FDA and sponsor audits of investigators and others, issues involving human subjects, sponsors, and institutions.
Convey the Board's concerns by composing written correspondence to investigators and sponsors. This may include requesting additional information and providing the rationale for required changes.
Identify and assist in the resolution of problematic review items, through interaction with investigators, sponsors and other IRB clients
May assist in performance of expedited review of protocols and other submissions, making appropriate decisions on behalf of the Board.
CLIENT SUPPORT
Advise clients of applicable scientific information and regulations pertaining to human subject research, both orally and in writing.
Provide guidance to clients to help resolve scientific, ethical and regulatory issues and difficulties.
SCIENTIFIC AND REGULATORY RESEARCH
Remain current on medical science and regulations pertaining to human subject safety.
OTHER DUTIES
Consult and advise clients for specific projects per contractual requirements.
Demonstrate thought-leadership in human subject protection through developing written materials (editorials, journal publications) and presentation at conferences, alone or in collaboration with colleagues
Review literature and other materials to keep abreast of developments in the regulatory, legal, and ethical arenas.
Other duties as assigned. These may, on occasion, be unrelated to the position described here.
Attendance and punctuality are essential functions of the job.
