Responsible for coordinating and reviewing caseload of applications related to human subjects research projects submitted for Institutional Review Board (IRB) review, maintaining data archiving system and supporting researcher community.
Duties and Responsibilities:
Understands and applies the Federal Regulations for human research to all project applications submitted for category determination and each level of IRB review (pre-review, re-review, clarifying issues, post meeting, Non-committee review) to ensure adherence to regulatory and ethical standards
Conceptualizes and can formulate the complexity of a project and provide guidance on next steps while integrating the PPHS Program’s values and objectives with the overall objective of making the process easier for processing
Consults on project development and design, consent processes, and data storage solutions to facilitate quality science in the construct of the Federal Regulations and Institutional policies
Independently decides on project determinations and acts as the non-committee reviewer for the majority of projects reviewed while also utilizing the office non-committee reviewer process as well
Conceptualizes the steps necessary for final resolution of work/projects and follows through with appropriate steps to deliver final project approval/determination within office metric requirements
Serves as a resource on general regulatory information and provides guidance about forms and submission procedures and prioritizing work
Serves as a resource in making project regulatory determinations and may make final determinations
Maintains documentation and records in accordance with departmental policies and procedures and ensures that all records are secured and properly archived
Maintains computerized database for tracking purposes. Enter or update database for complete submissions to PPHS
Composes and distributes correspondence to investigators on behalf of the Board, Directors, or Chairs
Serves as an IRB member, may attend Board meetings
Independently reviews an average of 700 project submissions annually
Performs other related duties
Some remote work and or compressed work weeks allowed based on office policy.
Bachelor’s degree; Masters preferred
Certified IRB Professional (CIP) or successfully earn the CIP certification as soon as possible (limited to two exam sessions)
1-3 years of direct IRB analyst (or equivalent) experience
Strong written and oral communications skills
Strong interpersonal skills
Excellent organization skills
Intermediate Adobe Acrobat Standard/Professional
Internal Number: Req# 2515700
About Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai is proud to stand as a leader in medical and scientific training, biomedical research and patient care. Our unwavering dedication to intellectual exchange, multidisciplinary teamwork and innovation propels us ever forward in discoveries and advances to improve the human condition.
Icahn School of Medicine attracts outstanding scientists, clinicians and students, all of whom share a deep commitment to expanding biomedical knowledge, providing expert clinical care and serving the community. Working in close partnership with The Mount Sinai Hospital, the Icahn School of Medicine serves one of the most diverse and complex patient populations in the world. Our passion for patient-focused research and education has inspired generations of physicians and researchers to learn, teach and practice breakthrough translational medicine on our campus. Fast paced and forward thinking, we continue to build upon this legacy.