Senior Clinical Research Coordinator

Company: Massachusetts General Physicians' Organization
Location: Boston
Posted on: February 25, 2021

Job Description:

Job Description - Senior Clinical Research Coordinator (3139830) Senior Clinical Research Coordinator - ( 3139830 ) The REU is a National Center for Translational Research in Reproduction and Infertility, funded by the National Institute of Child Health and Development (NIH). The Unit is also a new recipient of a Gates Foundation Grand Challenge Award. Dr. Seminara, Unit Chief, is PI on an NIH Merit Award (R37) which provides 10 years of funding for her translational studies. Thus, the Unit is securely funded for the next 10 years and is eager to welcome a staff who are committed to making the Unit their professional home. As someone who has passed through the ranks of CRC1 and CRCII, a SCRC candidate will able to work fairly independently to advance the mission of the research team. The lists below encompass most of the specific tasks that a SCRC will be expected to perform. They include Program Communication and Protocol Design and Execution. However, in any one of these tasks, there will be day to day challenges that are unexpected. When a hurdle emerges, a SCRC is expected to take the next step and trouble shoot the problem. A SCRC must not just "do their job" but recognize problems, identify solutions and begin to work toward those solutions. S/he must show flexibility to help others when help is needed, even if it means re-prioritizing his/her own work for the day. S/he helps serves as an important link between project/program managers and the CRC's. The ideal candidate will possess strong communication skills, have some experience with strategic planning and be knowledgeable of the operations of a research unit which includes both PIs and the Chief. Therefore, even though a SCRC may report directly to a project or program manager, s/he should expect to engage with the PIs and the Unit Chief regarding tasks, productivity, and workflow. In other words, the SCRC should expect that communication is not siloed within a hierarchical framework but is open and transparent amongst all members of the Unit. Interested candidates should submit a cover letter and three references with his/her application. PRINCIPAL DUTIES AND RESPONSIBILITIES: The SCRC coordinates and oversees the implementation and activities of multiple concurrent clinical research studies/trials, with responsibilities including: Program Communication: -- Collaborate with all staff and Chief regarding technical and research developments. -- Strategize with staff when problems arise and offer solutions. -- Read communication from regulatory agencies (be they internal or external) and determine which issues require immediate attention. -- Ensure uniform application of regulatory requirements across PI/Chief's program as well as other REU programs. -- Stay abreast of the changing regulatory landscape at MGB by attending appropriate meetings/councils/etc. -- Communicate with internal regulatory agencies such as the IRB and the DSMB. -- Help to coordinate new protocol submissions, response to review, and continuing review with the IRB. -- Help to draft new protocol submissions, response to review and continuing reviews. -- Ensure compliance with MGH, IRB, NIH, FDA regulatory requirements and research goals when drafting regulatory materials. -- Communicate with hospital staff. -- Communicate with non-Reproductive Endocrine Unit investigators. -- Follow through on communications. Protocol Execution and Design: -- Recruit study subjects; -- Assist in screening; -- Review screening data to determine eligibility; -- Report concerning screening data to the PI; -- Coordinate with clinical staff; -- Aid with study procedures; -- Perform project related tasks. These include (but are not limited to) cross checking of samples and consents, data entry, label making, blood sample processing, sample packaging and sample mailing. -- Maintain study documents and enrollment tables; -- Perform data analysis; -- Ensure that all study staff follow GCP procedures and adhere to safe practices in the conduct of clinical research. 1. Regulatory Compliance - Develops and maintains protocol specific systems for Quality Assurance/Quality Control, IRB amendment and reviews, and external regulatory submissions. These tasks include: -- Update and verifies accuracy of study forms per protocol; -- Monitor and report adverse events as required by institutional/federal regulations; -- Maintain regulatory binders for protocols and INDs; -- Assist in maintaining and preparing documents and submissions for INDs; -- Facilitate integration of regulatory issues to ensure safe practice; -- Develop and maintain systems for QA/QC; -- Contribute protocol recommendations; -- Prepare and submit protocols, reports and regulatory submissions as required by FDA, NIH, IRB, MGH subcommittees (Clinical Trials Pharmacy, TCRC) 2. Data Management - Obtains and organizes patient data from medical records, physicians, etc., using HIPAA/GCP guidelines: -- Data entry and analysis; -- Conducts library and internet searches; -- Uses software programs to generate graphs and reports; -- Contributes to development and maintenance of research data, subject files, and study databases; -- Assists with formal audits of protocol/INDs. 3. General Support: -- Assists Program and Administrative Managers with pre-award administrative activities, such as: -- Compiling and modifying budgets, justifications, contracts, subcontracts, and MCA's; -- Obtaining and editing "Biographical Sketches", "Other Support", "Resource & Equipment" forms, checklists, MGH cover sheets, and other forms, as required by the sponsor; -- Identifying and resolving any issues regarding applications prior to submission; -- Training and orienting new study staff; -- Execute all program operations, including: -- Draft or review SOPs, training documents, and workflows. -- Ensure that SOPs are followed. -- Enforce uniform standards for data management across the Unit. -- Orders clinical research laboratory and office supplies and manages inventories; -- Oversees bio-tissue sample processing, per study protocol; -- Maintains sample collection repository; receives, ships and stores specimens, as required by protocol; -- Participate in conference calls and other meetings as directed; -- Perform other duties and responsibilities at the supervisor's request. QUALIFICATIONS: -- Bachelor's degree (required); MA/MS/MPH (preferred);-- 2-4 years of research related experience (required);-- CCRC (preferred)SKILLS/ ABILITIES/ COMPETENCIES REQUIRED: -- Maintain current CITI certification and has proficient understanding and knowledge regarding GCP;-- High level time management skills requiring exceptional organizational skills and the ability to prioritize effectively. This includes the ability to ask for direction when appropriate and the flexibility to handle multiple tasks and deadline pressures.-- Extraordinary attention to detail, ability to work carefully and efficiently with minimal supervision;-- High level of proficiency with Microsoft Excel, Word, PowerPoint and computer data entry skills required;-- Experience with medical chart reviews and electronic medical records;-- Knowledge of database management strongly preferred;-- Clinical knowledge as required for chart reviews;-- Ability to interpret acceptability of data results;-- Good judgment and problem solving skills, ability to simultaneously coordinate multiple tasks, people and schedules;-- Ability to demonstrate professionalism, compassion and respect for study participants' rights and needs-- Excellent oral and written communication skills in English;-- Ability to work both independently and as part of a busy, multidisciplinary team, interacting with diverse individuals at multiple levels within the research and clinical group;-- Ability and willingness to learn new research and administrative skills;-- Work hour flexibility. Some visits start early in the morning (7 am) and there may be intermittent work after normal business hours including weekends.WORKING CONDITIONS: Every effort will be made to keep to traditional work hours of 40 hours per week. However, the SCRC position is different from the CRCII position in that work hours are defined by the nature of the work itself and there is no longer a 40 hour work week limit. Therefore, a SCRC, at times, may be called upon to come in early, stay late or work on weekends. For example, evening hours may be needed to follow-up with study participants by phone and/or meet with staff. If a SCRC works early, late or on a weekend s/he should not request to "make up the time" the following week as that is the not the spirit of the position. (The same expectation holds for project & program managers, fellows, and faculty.)SUPERVISORY RESPONSIBILITY:----Will participate in the supervision of clinical research coordinator I/II, interns, and volunteers.FISCAL RESPONSIBILITY: Responsible for managing research project and program material supplies within budgetary guidelines. Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from--protected veterans and individuals with disabilities are strongly encouraged. -- Primary Location Work Locations MGH Main Campus Job Clinical Organization Massachusetts General Hospital(MGH) Schedule Full-time Standard Hours 40 Shift Day Job Employee Status Regular

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