Job details
Job type full-time
Full job description
Remote opportunity
Provides regulatory expertise, guidance and administrative support to the dartmouth-hitchcock (d-h) institutional review board(s) (irb).
Responsible for processing submissions according to the policies and procedures outlined in the d-h human research protection program (hrpp) toolkit and serves as a regulatory resource to support irb reviewsHas the primary responsibility of moving submissions through the office workflow in a timely manner, ensuring that submissions are review ready prior to routing for review, conducting certain non-committee reviews, and generating correspondence after the review process is complete along with coordinating the activities of irb panels.
Responsibilities: 1Complies with the d-h hrpp toolkit which includes applicable local and federal regulations, rules, guidelines and ethical principles and perform duties as specified in the d-h hrpp toolkit.
2Processes submissions to the irb office as assigned, including new studies, modifications, continuing review, and reports of new informationConducts pre-review to ensure that submissions are review ready, routes submissions appropriately for either non-committee or committee review and communicates review results to investigators and others as needed.
3Escalates matters of concern to the hrpp director or irb manager as appropriate.
4Conducts non-committee review for certain submissions as determined by the hrpp director or the irb manager.
5Prepares for, coordinates and facilitates irb committee meetings, which includes, but is not limited to:
APreparing submissions for review by the convened irb
BAssigning reviewers to submissions
CManaging irb meeting agenda volume
DConfirming irb member meeting attendance to ensure quorum
EMonitoring quorum during irb meetings
FDocumenting determinations made by the convened irb
GGenerating irb meeting minutes and correspondence
HProviding regulatory guidance to the irb chair and members
IReviewing submissions in order to anticipate regulatory issues for which irb members may need assistance (e.g., ind/ide questions)
6Serves as a resource to irb members, researchers and key personnel by providing support for the preparation of research applications, including guidance on applicable regulations, and subsequent submission in the electronic irb protocol system.
7Maintains d-h collaborative institutional training initiative (citi) training account and provides guidance to researchers and research staff needing assistance with citi training.
8Assists leaders in researching, developing, and conducting continuing education opportunities for the research community, ensuring continual and up-to-date awareness of the federal regulations which govern human subjects research.
9Monitors, evaluates, and provides feedback to leaders regarding updates/edits needed to the d-h hrpp toolkit and educational needs (deficiencies) of the irb committee, research community, and irb staff.
10Maintains current working knowledge of the regulations for the safety and protection of human subjects in research and stays current of any changes to the regulatory landscape that may affect the research community.
11Performs other duties as required or assigned.
Minimum qualifications: ü bachelor’s degree in a related field or the equivalent in education and experience with a minimum of two (2) years of directly related experienceÜ other combination of education and work experience that provides required knowledge, skills, and abilities deemed necessary for this position allowedÜ certified irb professional (cip) certification preferred ü prior irb experience preferred ü expertise in regulations pertaining to the protection of human subjects, including hhs, fda, and hipaaÜ knowledge of microsoft office programs: word, excel, powerpoint, outlook; internet functionsÜ strong knowledge of protocol processes and approval mechanisms included in ongoing human subject research oversightÜ strong communication (written and oral), interpersonal, and customer service skills needed to work closely and effectively with researchers, committee members and administrative personnelÜ detail-oriented with the ability to multi-task and prioritize workload.
Required licensure/certification skills: ü certified irb professional (cip) expected after one year in the job based on certification requirements.
