New

Clinical Research Coordinator II

Massachusetts General Hospital
United States, Massachusetts, Boston
100 Cambridge Street (Show on map)
Apr 22, 2025
Summary Works independently under minimal supervision to enroll eligible patients to clinical research protocols and manage all aspects of data collection and submission for multiple cancer studies. Will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. Will have experience with institutional and federal regulations governing clinical research. In addition, +may assist management in the areas of Quality Control and Training & Development, and may provide input into the assessment of departmental procedures. The position involves a combination of data abstraction and entry, regulatory management, and patient coordination. The position involves direct patient contact. Does this position require Patient Care? Yes Essential Functions -Identify changes associated with Standard Operating Procedures and develop procedure to ensure compliance. -Manage studies of a particular specialized program. -Pre-activation activities including pre-site qualification visits, SIVs, and facility tours. -Organize and prepare for internal/external audits. -Assist clinical team in screening potential patients for study participation. -Develop protocol specific flow charts, intake sheets, and other tools to ensure protocol compliance and proper data acquisition. -Obtain protocol clarifications from the study sponsor and communicate information to the research team. -Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required. -Schedule and prepare for monitoring visits with sponsors. General Summary/Overview Statement This is an exciting opportunity for a clinical research coordinator (CRC), who is interested in working on projects focused on patient-centered, innovative and data-driven care. Under the general direction of the Director of Research in the Division of General Internal Medicine (DGIM), the clinical research coordinator will assist with multiple pilot research projects in the Center for Transformation of Internal Medicine (CENTRI). The incumbent will assist with projects focused on implementing and evaluating innovative and educational programs in primary care with a particular focus on projects that address social determinants of health, vulnerable populations, or virtual care and digital health. The CRC will work as part of a dynamic and enthusiastic team of primary care physicians, researchers, educators and other key personnel. The candidate must demonstrate organizational, administrative, time management, and communication skills, as well as intellectual independence and initiative. The ability to work both independently and as part of a team is essential. The clinical research coordinator must maintain professionalism at all times. Other job duties and responsibilities are listed in detail below. Principal Duties and Responsibilities The responsibilities of the clinical research coordinator may include but are not limited to the following activities: Contact eligible patients, prepare study mailings and reminders. Manages subject recruitment, assesses eligibility for studies including pre-screening and follow-up calls. Perform data collection from a variety of sources, including patient medical records, and hospital clinical information systems and surveys. Conduct data entry, quality checks on data entry and preliminary data analysis. Utilize REDCap to enable data collection efforts, including development of case report forms and descriptive data analysis. Manages all Institutional Review Board (IRB) documentation accurately. Drafts and submits applications to the IRB, including initial submissions, amendments, and continuing review Perform literature searches and specialized database searches. Retrieve journal articles from the Internet or library. Maintains a bibliographic library of supporting materials. Assist with the preparation of formal research reports and manuscripts for publication in professional journals. Helps with the preparation of talks and presentation materials including PowerPoint slides, tables and graphs. Coordinate project meetings including preparation and distribution of agenda and follow-up action items. Maintains a good understanding of the study protocols and study start-up/closeout process Will support project management activities to help keep project proceeding efficiently. Photocopying, electronic mailing, receiving and sending mail, scheduling meetings and conference calls, taking minutes at meetings and on conference calls, faxing, scanning, and other administrative duties as required. Education Bachelor's Degree Related Field of Study required MPH, Master's degree or prior coursework in health-related topics and/or research methods is preferred but not required Can this role accept experience in lieu of a degree? No Licenses and Credentials Experience Clinical Research or Compliance experience required Knowledge, Skills and Abilities - High level time management and organization skills. - Excellent written and verbal communication skills. - Knowledge of current and developing clinical research trends. - Sound interpersonal skills and the ability to mentor others. - Ability to work independently and display initiative. - Ability to identify problems and develop solutions. Physical Requirements Standing Frequently (34-66%) Walking Frequently (34-66%) Sitting Occasionally (3-33%) Lifting Frequently (34-66%) 35lbs+ (w/assisted device) Carrying Frequently (34-66%) 20lbs - 35lbs Pushing Occasionally (3-33%) Pulling Occasionally (3-33%) Climbing Rarely (Less than 2%) Balancing Frequently (34-66%) Stooping Occasionally (3-33%) Kneeling Occasionally (3-33%) Crouching Occasionally (3-33%) Crawling Rarely (Less than 2%) Reaching Frequently (34-66%) Gross Manipulation (Handling) Frequently (34-66%) Fine Manipulation (Fingering) Frequently (34-66%) Feeling Constantly (67-100%) Foot Use Rarely (Less than 2%) Vision - Far Constantly (67-100%) Vision - Near Constantly (67-100%) Talking Constantly (67-100%) Hearing Constantly (67-100%) The General Hospital Corporation is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.