Scientific Review & Monitoring Coordinator

Job title: Scientific Review & Monitoring Coordinator

Company: Lifespan Health System

Job description: Job Description:Summary:This role is part of the Lifespan Office of Cancer Research department. The Scientific Review & Monitoring Coordinator provides administrative support to the Scientific Review and Monitoring Committee (SRMC) and the department regulatory department. Under the direction of department Regulatory & Quality leadership, the coordinator will facilitate scientific review and National Cancer Institute-mandated reporting utilizing knowledge of clinical research principles and regulations. Responsibilities include providing administrative support and coordination to the SRMC, including facilitating twice monthly initial review committee meetings and continuing review committee meetings; identifying protocol trends and communicating with collaborators to resolve or modify research activity; providing education to research staff regarding protocol submission, committee decisions and protocol management responsibilities; developing, implementing, and maintaining relevant Standard Operating Procedures and policies; collaborating with departmental regulatory staff to ensure that initial submissions are accurate and data associated with SRMC continuing reviews are accurate and entered into the CTMS. The coordinator will use OnCore, RedCap and PowerBI, which are all specialized databases, to build, evaluate and track submissions and monitor research protocols.The successful candidate must demonstrate strong communication skills, the ability to manage multiple projects independently and collaboratively, and excellent attention to detail, time management, and organizational skills.Responsibilities:Serves as a liaison among the Principal Investigator/research team, SRMC committee members, regulatory staff, and other collaborators to administer protocols, ensuring goals and objectives are met according to SRMC Charter. Involved with the management of external sites participating in trials being reviewed by SRMC.Collaborates with investigators, departmental and committee leadership, regulatory staff, and other collaborators to rapidly move clinical trial research protocols through the SRMC activation process. May assist the activation team with the coordination of and communication related to new clinical trial opportunities.Interfaces with investigators, research staff, and collaborators to maintain clinical trials, including annual reviews, evaluating accrual, ensuring timelines and milestones are met; assists with, or is responsible for proper study close-out procedures and communication to ensure proper trial management. Request and following up for Corrective and Preventative Actions associated with low target accrual to studies where anticipated accrual is not met.Serves as point of contact for external institutions participating in clinical research studies being reviewed by the SRMC. Ensures data is entered accurately by study team(s), which may include monitoring study records for completeness and accuracy.Perform timely screening/review of submission to ensure completeness. Timely communication with investigators/study team regarding SRMC submissions. Provide pre-review for incoming submissions requiring administrative non-committee review, determine adequacy of applications and level of review required, select reviewers for protocol reviews, follow-up with SRMC reviewers to assure appropriate level of review provided, and prepare outcome letters and finalized documents.Coordinate all SRMC meetings by creating agendas, prepares for in-person and virtual meetings, record meetings, and ensure quorum is achieved and is maintained throughout meetings. Create voting polls for each meeting and capture voting assignments. Create and maintain meeting minutes. Record data in various databases.Create and maintain all membership appointment letters. Maintain the membership list and SRMC charter. Assist with updating SRMC charter, as necessary, and ensure that changes are made in tracked form for change record. May assist with the communication of SRMC Charter and membership updates to the committee.Monitor the SRMC general email inbox and respond to requests for information, complaints, and concerns.Provide education and training on use of SRMC electronic management system with the research community, as needed and necessary.Assists with training staffAssists on special projects as needed. Must work independently, possess ability to educate and act as a resource to research staff.Other information:BASIC KNOWLEDGE:Bachelor’s degree in health-related or scientific field, is preferred. In lieu of Bachelor’s Degree, two or three years of experience in coordinating a committee, research administration, compliance or regulation, is appropriate.Must be an independent person, who is capable of making sound judgment pertaining to SRMC concerns and have the ability to work independently within the scope of the job requirements.Strong-self-starter, interpersonal skills, and influence are necessaryTeam-oriented with excellent oral and written communication skillsStrong problem-solving skillsExcellent self- management and organizational skillsDetail-orientedComputer skills in Microsoft officeMust be proficient in various database applications, such as OnCore, RedCap, and PowerBI.Ability to foster smooth communications and teamwork among clinical research faculty, fellows and staff as well as external organizations necessaryEXPERIENCE:One (1) year related experience with coordinating a scientific committee, such as SRMC or PRMC, is preferred. One (1) year related experience in research administration, clinical research or human subject protection, regulatory compliance or research related job.This experience may include working with research investigators, IRB submissions, processing, approvals, IRB, SRMC, or PRMC meeting minutes, demonstrating knowledge of and ability to interact related requirements of the sponsor and federal regulations.Basic knowledge of federal regulations pertaining to research, HIPAA, ICH GCP at a level sufficient to function independently as a consultant to clinical investigators such preferred.WORK ENVIRONMENT AND PHYSICAL REQUIREMENTS:This position is a sedentary position. One must be able to transport paperwork to another building (sometimes up to 10 lbs.) at one time. Bending and stooping may also be requirements for filing of paperwork. Standing to copy may also be required.INDEPENDENT ACTION:This position requires a quick-thinker, who can independently make basic and sometimes complex decisions pertaining to the completion and transmission of required documentation for SRMC, as well as internal and external departments, including, but not limited to study sponsors. The candidate should be able to answer SRMC review inquiries from researchers and physicians, as well as from committee members. This person should also be able to work independently. They should be able answer inquiries related to SRMC review issues, and if not known, communicate with the correct person to determine the answer.SUPERVISORY RESPONSIBILITY:NoneLifespan is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, ethnicity, sexual orientation, ancestry, genetics, gender identity or expression, disability, protected veteran or marital status. Lifespan is a VEVRAA Federal Contractor.Location: Rhode Island Hospital, USA:RI:ProvidenceWork Type: Full TimeShift: Shift 1Union: Non-Union

Expected salary:

Location: Providence, RI

Job date: Sat, 05 Oct 2024 06:26:00 GMT