Clinical Research Coordinator II NEUROLOGY HL
 Brigham and Women's Hospital | |
 United States, Massachusetts, Boston | |
| 60 Fenwood Road (Show on map) | |
 Jun 25, 2025 | |
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Summary
Works independently and under general supervision from the Administrative Director of the CNCT and the Principal Investigator to support clinical research studies. This role may be responsible for the following activities: making independent judgments of the suitability of potential participants for clinical trials, developing and implementing patient recruitment strategies, recommending protocol changes, and overseeing the work of more entry-level staff. Collecting and organizing patient data; scheduling patients for study visits; maintaining and updating data generated by the study; all IRB submissions such as applications, amendments, annual reviews, and adverse events, and communicating with national and international research collaborators. 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. Additionally, it provides input into determining study subject suitability and input into recruitment strategy. Performs data analysis, interpretation, QA/QC, and assists in completing reports and presentations. Does this position require Patient Care? No Essential Functions - Assists with determining the suitability of study subjects and acts as a resource for patients and families. - Has input into recruitment strategies and may contribute to protocol recommendations. - Administers scores and evaluates study questionnaires. - Maintains research data, patient files, regulatory binders, and study databases. - Performs data analysis and QA/QC checks and organizes and interprets data. - Assists with preparation for annual review and assists PI in completing study reports and presentations. - May assist with training and orientation of new staff members. Principal Duties and Responsibilities - Assists with clinical research studies as per study guidelines and protocols. - Screen for eligibility, recruit and evaluate potential study patients. Per protocol instruction, conducts telephone interviews or schedules patients for in-person study visits and screening. - May be required to perform clinical tests such as questionnaires, cognitive assessments, etc. if certified and as needed. Will work with colleagues in research labs to set up lab testing, shipping, etc. - Responsible for collecting data and maintaining the patient information database for several studies. It may be required to input data. Maintains study subject records as a part of the record-keeping function. Prepares data for analysis and data entry. - Interact with patients/subjects regarding the studies, including patient education, procedural instruction, and follow-up. Prepare materials to advertise studies. Answers any phone calls and inquiries regarding study protocol. Refers participants when appropriate to supervisor or clinical staff. - Will serve as a liaison between patient and physician. First point of contact for study communication. Advocate for patients to ensure a good experience while in your trial and assure compliance. - Communicates with sponsor companies, CRAs, central labs, and testing facilities, both external and internal. - Responsible for scheduling all research meetings with monitors or sponsors. - Creates, distributes, and files all study documents per protocol and updates them as needed. - Responsible for various study information or packets, i.e., schedules, directions, and reimbursements to study participants. - Responsible for staff study training. - Prepares and submits all IRB documents: applications, amendments, annual reviews, and serious adverse events. - Oversees study budgets and patient reimbursements. - Monitors and sets up any needed equipment. - Maintains inventory and orders supplies when necessary. - Maintains all study regulatory documents. - All research administrative tasks. Education - At least one year of work experience in a research setting. Sound independent judgment and competence in research methodologies. - Excellent interpersonal skills are required to work with the study participants, PIs, research collaborators, colleagues and supervisors. - Good oral and written communication skills. - Knowledge of clinical research protocols. - Knowledge of GCP and ICH guidelines. - Knowledge of computer programs, databases, etc. - Able to work independently. - Able to multi-task on several project simultaneously, and shift focus multiple times per day. - Able to work under deadline pressure Ability to problem solve quickly and accurately. - Excellent organizational skills and ability to prioritize and delegate a variety of tasks. - Careful attention to detail. - Ability to demonstrate professionalism and respect for subjects' rights and individual needs. - Ability to work with vulnerable subjects (pregnant women with neurologic illness). - Basic knowledge of human anatomy, physiology, pharmacology Working Conditions Work throughout the hospital areas such as clinic, labs, clinical trials center. Must be able to go independently to the investigational drug services pharmacy on L-2 to pick up investigational product, to clinic on ground and first floor. Daily operations conducted in open office cube space. May be required to lift boxes to ship to central lab or boxes of lab supplies. The Brigham and Women's Hospital, Inc. 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. | |