New

Clinical Research Coordinator I - Liver Center/Gastroenterology

Massachusetts General Hospital
United States, Massachusetts, Boston
80 Blossom Street (Show on map)
May 12, 2025
The Liver Research Group in the Digestive Healthcare Center at the Massachusetts General Hospital seeks a highly motivated, self-directed individual for the position of Clinical Research Coordinator (CRC). This individual will be responsible for all study tasks related to data and sample collection for the Group's tissue repositories including: subject enrollment, follow-up visits and phone calls, capturing clinical data, scheduling and performing blood draws and study visits, processing biologic specimens and maintaining relationships with collaborators. In addition, this position will involve assigned roles on other studies and industry-sponsored clinical treatment trials; there will be a strong focus on regulatory start-up, patient recruitment and retention for these studies. Finally, this individual will have the opportunity to learn and perform some basic genetic and epigenetic assays on samples collected for the tissue repository as a part of ongoing translational studies, and will have the opportunity to learn basic computational and data visualization techniques for the resulting data. The ability to work independently and to organize workflow efficiently is a must. The schedule will require flexibility and may include occasional evenings and Saturdays depending on time-management and patient schedules. An ideal candidate would possess a strong undergraduate lab background in biology, biochemistry, or chemistry. A data analysis background with some experience interacting with patients in a healthcare setting would also be desirable. Experience in customer service and a keen interest in the medical field is strongly preferred. Basic familiarity with programming languages and statistical analysis tools, particularly Python and R, is beneficial but not required. This position offers the opportunity to work directly with patients, nurses, and physicians and learn the basics about clinical, translational, and computational research in a large academic medical center. PRINCIPAL DUTIES AND RESPONSIBILITIES: Liver Repository Responsibilities Assist in management of study operations and ensure integrity of study Enroll patients with liver disease at clinics throughout Massachusetts General Hospital Draw blood samples and coordinate sample management and processing (including urine, stool and tissue samples) Capture and enter clinical information from record review and patient interview into study database Perform bio-specimen processing, aliquoting, tracking and shipping Keep bio-specimen electronic and physical inventories current and available Perform Institutional Review Board (IRB) submission process by preparing protocol applications, amendments, safety reports, adverse event reports and other required documents Act as primary study resource for lab staff, patients and families Nurture relationships with other study coordinators in other divisions Develop, implement and improve recruitment strategy Fulfill sample and data requests and provide reports on data and samples pulled Attend weekly coordinator meetings and prepare reports of work performed and projects in process Clinical Trial Responsibilities Manage study operations and ensure integrity of study Facilitate IRB submission process by preparing protocol applications, protocol amendments, safety reports, adverse event reports and other required documents. Manage and maintain regulatory documents for audit by sponsor or FDA. Assist recruitment and/or randomization of subjects per study protocol Act as primary study resource for lab staff, patients and families Arrange and conduct initial interviews of study subjects and evaluate criteria for inclusion/exclusion per study protocol; coordinate subsequent assessments of subjects as outlined in study protocol Assess subject's health through interviews; take subjects vital signs Perform phlebotomy on subjects; process and ship specimens Evaluate medical records and laboratory results for study relevant clinical data Coordinate subject care by scheduling follow-up assessments and communicating concerns about the subject with the study investigator and the subject's primary care provider Maintain subject charts and other data per the protocol and assess data for quality and completeness Conduct ongoing review of study progress and provide investigators with progress reports Attend regular coordinator meetings and prepare reports of work performed and projects in process SKILLS/ABILITIES/COMPETENCIES REQUIRED: * Excellent analytical skills and the ability to resolve technical or research problems and to interpret the acceptability of data results * Experience and competency in basic lab techniques and lab notebook keeping - undergraduate experience in Biology/Chemistry labs at a minimum. * Ability to independently problem solve and show high degree of resourcefulness * Highly motivated, self-directed and driven to meet study goals * Excellent communication skills and willing to assume study leadership role * Ability to manage time independently, effectively and efficiently * Ability to juggle multiple tasks, people and schedules. * High degree of computer literacy, knowledge of Microsoft Office suite * Excellent organization skills and ability to prioritize a variety of tasks * Ability to demonstrate professionalism and respect for subjects' rights and individual needs EDUCATION: * BA/BS degree required EXPERIENCE: Biology and/or laboratory science background preferred, but not required Biostatistics background preferred, but not required Experience programming bioinformatic and statistical analyses in R or Python preferred, but not required FISCAL RESPONSIBILITY: Study coordinator will be responsible for submitting and tracking sponsor invoices for milestone payments. In coordination with the research grant manager, CRC will review and reconcile study funds against invoices and follow-up on outstanding payments. WORKING CONDITIONS: * Position includes conducting subject visits within a medical office setting and handling biological specimens following universal precautions for blood/stool processing, handling and shipping. Ability to lift up to 25 pounds required. * Day shift with flexibility for evening/weekends depending on time management and patient schedules 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.