Clinical Research Coordinator
 Massachusetts General Hospital | |
 United States, Massachusetts, Boston | |
| 100 Cambridge Street (Show on map) | |
 Jun 13, 2025 | |
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GENERAL SUMMARY/ OVERVIEW STATEMENT:
The candidate will work with an internationally recognized, multidisciplinary team from Massachusetts General Hospital and Harvard Medical School, alongside collaborators from many institutions. Specific studies include large observational database research and research that includes enrollment of patients into cohort and clinical trial studies. Working very independently and under very general supervision from Research Manager and/or Principal Investigator, provides support to clinical research studies. May be responsible for the following activities: making independent judgment of suitability of potential participants for clinical trials and registries, screening and scheduling potential participants for clinical trials, developing and implementing patient recruitment strategies, performing applicable clinical tests such as phlebotomy, vital signs, ECGs, etc. maintaining and updating data generated by the study. JOB DESCRIPTION: 1. Working with other research coordinators supporting clinical research activities for department. 2. In conjunction with Research Manager/Principal Investigator, develops and implements new research protocols including design, data collection systems and institutional review board approval. 3. Recruitment of patients for enrollment in clinical trials and registries. Interacts with patients prior to entering the study and throughout the entire treatment. Discusses and obtains informed consent with patients. 4. Organizing strategies for recruiting study patients. 5. Screening patients for eligibility and enrolling eligible candidates. 6. Conducting study visits. 7. Working closely with the Principal Investigator and other staff on implementing clinical studies and registries. 8. Preparation of protocol applications, maintaining regulatory binders, case report forms, source documents, and other study documents as well as monitoring and reporting the occurrence of clinical adverse events. 9. Maintaining and updating information as required by Hospital and Sponsor/NIH guidelines. 10. IRB applications and submission 11. Manage study finances: maintain positive financial status of studies, prepare invoices and track payments, facilitate subject payment and reimbursement as applicable per study contract Investigator support Organize meetings and meeting schedules Manuscript and presentation preparation: literature reviews, citation management, drafting, basic data manipulation, table and figure creation Clinical operations support as needed Following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc.; maintaining and updating data generated by the study. Candidates who are in the process of completing their bachelor's degree have a grace period of six months from their hire date (up to 1 year if starting per diem) to provide degree equivalency verification. Essential Functions Reviews proposals for compliance with sponsor and organizational guidelines; verify all sponsor requirements are met Recruiting patients for clinical trials; conducts phone interviews Verifies the accuracy of study forms and updates them per protocol Prepares data for analysis and data entry Documents patient visits & procedures Assists with regulatory binders and QA/QC procedures Assists with interviewing study subjects Assists with study regulator submissions Performs other duties as assigned Complies with all policies and standards EDUCATION: Bachelor's degree required. EXPERIENCE: New graduates with some relevant course/project work or those without any prior research experience will be considered for the Clinical Research Coordinator I position outlined above. Those with a minimum of 1-3 years of directly related work experience will be considered for a Clinical Research Coordinator II position. Experience with Good Clinical Practice, CRFs, laboratory processes, safety practices, specimen shipping/handling, and study conduct. SKILLS: Ability to work independently. Excellent interpersonal skills are required for working with the study participants. Good oral and written communication skills. Analytical skills and the ability to resolve technical or research problems and issues and to interpret the acceptability of data results. Knowledge of clinical research protocols. High degree of computer literacy. Excellent organizational skills and ability to prioritize a variety of tasks. Careful attention to detail. Ability to demonstrate professionalism and respect for subject's rights and individual needs. 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. | |