Research Coordinator

SUMMARY: Under the direction and guidance of the Manager, Board Services, this position provides administrative support to the Manager, IRB members, clients, investigators, and study personnel. ESSENTIAL DUTIES AND RESPONSIBILITIESOther duties may be assigned as needed.Ensures compliance with Federal Regulations, ICH Guidelines, Standard Operating Procedures (SOPs), and company policiesProvides procedural guidance to board members, team members and clientsCoordinates activities associated with the planning, facilitating, and follow-up of convened IRB meetings, IRB action items and expedited review items such as:Processing of:initial protocol, new investigators, continuing review, protocol amendments, consent form document revisions, recruiting materials, protocol deviations, investigator non-compliance, etc., within the established turnaround timeAttends and facilities multiple weekly IRB meetingsActively participates in the Board meeting to ensure Board review and discussion of all agenda items and ensures the meeting minutes are accurately recorded, as specified by Salus IRB policy and procedures Reviews study documents submitted for IRB review and completes appropriate checklists May assist with day-to-day expedited review requests from clients such as minor ICD revisions and recruiting/study materials Communicates effectively with clients, staff members, board members, investigators, and study personnel to identify and resolve issues, responding to inquiries in a professional and timely mannerPrepares and finalizes IRB meeting agendas and minutes, and ensures action items are processed and communicated to the client accordinglyEnsures all agenda items requiring follow-up are appropriately documented on the meeting minutes and are followed through to resolution within the established timelineTracks and maintains IRB submissions in the databaseEnsures all study documents are filed in a timely manner and study files are maintained in accordance with company policyMay coordinate study document translations working directly with the vendorPerforms data entry, photocopying, scanning or posting documents to GlobeSync, the web-based document distribution systemMay assist in training of new employeesMay attend educational conferencesQualificationsTo perform in this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Education and/or ExperienceBA/BS degree preferredAt least two years experience supporting IRB activities or clinical trials experience preferred. Will consider other industry or related experienceWorking knowledge and interpretation of all IRB-related regulations preferredIndustry certification or willing/able to obtain certification within one year of hire is preferredKnowledge, skills and abilities:Excellent organizational and oral/written communication skillsDetail oriented; ability to provide accurate client deliverables in a fast-paced, deadline driven environmentMust be self-motivated with proven ability to prioritize and handle multiple tasks effectively and accuratelyAbility to establish priorities and respond promptly to a large variety of requests and needs, in a fast-paced and deadline driven environmentSuccessfully works independently and within a teamSuccessfully applies problem solving and critical thinking skillsKnowledge and application of MS Office Suite and other web-based programs To perform the job successfully, an individual should demonstrate the following competencies:Customer/Client service - Manages difficult or stressful client situations; responds promptly to client needs, solicits client feedback to improve service; responds to requests for service and assistance.Organization - Prioritizes and plans work activities and uses time efficiently; assists in setting goals and objectives.Language ability - Ability to read, analyze, and interpret general business documents, SOPs, regulatory documents, technical procedures, and IRB-related; writes business correspondence independently; speaks effectively and presents information and ideas clearly; responds concisely and efficiently to questions.

Created: 2025-02-03