Clinical Research Coordinator

Site: The General Hospital Corporation

At Mass General Brigham we know it takes a surprising range of talented professionals to advance our missionfrom doctors nurses business people and tech experts to dedicated researchers and systems analysts. As a notforprofit organization Mass General Brigham is committed to supporting patient care research teaching and service to the community. We place great value on being a diverse equitable and inclusive organization as we aim to reflect the diversity of the patients we serve.

At Mass General Brigham we believe a diverse set of backgrounds and lived experiences makes us stronger by challenging our assumptions with new perspectives that can drive revolutionary discoveries in medical innovations in research and patient care. Therefore we invite and welcome applicants from traditionally underrepresented groups in healthcare people of color people with disabilities LGBTQ community and/or gender expansive first and secondgeneration immigrants veterans and people from different socioeconomic backgrounds to apply.

Job Summary

Under general direction of the Chief of Neurosurgery and the Administrative Director for Research in Neurosurgery this individual is responsible and accountable for assisting in the implementation of research protocols for the MGH Cerebrovascular & Endovascular Neurosurgery team. This includes working with physicians clinical nurses and patients on active clinical trials to identify and recruit eligible patients obtain all necessary approvals and informed consent forms screen and enroll patients into the study assess patient participation on a continuous basis in light of ethical considerations and act as a liaison between the patient and other members of the team regarding the research protocol. Responsible for database development and data entry of patient data for the study. Works closely with the physicians involved in the study to contact the patients and families. Organizes visits and patient family interviews for participating physicians. Logs in all applicable data elements as requested and coordinates information and supply transfer as necessary to complete study elements at multiple sites. Summarizes data and information for review and analysis by the investigators and project team.
The Cerebrovascular and Endovascular Neurosurgery team at Massachusetts General Hospital is seeking a highly motivated Clinical Research Coordinator with a strong interest in neuroscience and clinical medicine to join our team. This role offers an opportunity to contribute to cuttingedge trials focused on advancing the treatment of cerebrovascular conditions including stroke aneurysms subarachnoid hemorrhage and arteriovenous malformations.
Our team is primarily engaged in multicenter clinical trials to evaluate the safety and efficacy of surgical devices and interventions. In addition we are involved in a variety of datasharing initiatives aimed at further advancing cerebrovascular research. The CRC is responsible for supporting all aspects of clinical research coordination for these investigations.
Key Responsibilities:
Patient Interaction & Study Coordination
oScreen potential participants obtain informed consent and track patients throughout the study duration to ensure adherence to protocols and longterm data collection.
oServe as a liaison between patients healthcare providers and study sponsors addressing inquiries and ensuring patient safety.
oConduct study visits administer questionnaires collect biological samples and perform standardized neurological assessments (motor and cognitive function).
Regulatory & Compliance Management
oOversee Institutional Review Board (IRB) submissions amendments and renewals to maintain regulatory compliance.
oMaintain accurate and uptodate study documentation ensuring adherence to Good Clinical Practice (GCP) and FDA guidelines.
oCoordinate with study sponsors regulatory offices and internal hospital departments to facilitate study progress.
Operating Room & Data Collection
oAttend neurosurgical procedures to collect intraoperative research data and observe the implementation of investigational devices and treatments.
oPerform realtime data entry and quality control to ensure accurate documentation for ongoing trials.
oSupport datasharing initiatives and retrospective analyses in collaboration with investigators and external research partners.

Perform administrative duties such as protocol design data analysis quality assurance grant preparation documentation for Human Studies approval study progress reports and manuscript preparation.

Coordinates and implements research study according to the study protocol. Assists with preliminary planning for the study including performing literature searches and developing data forms. Assists in the formulation of research aims and protocols. Demonstrates understanding and knowledge of designated study protocols and methods of implementation.

Organizes establishes and maintains research databases on active clinical trials and uses the databases to extract information for reports papers and feedback to the study team.

Collects compiles tabulates and analyzes research data. Ensures that data is entered into the database accurately and in a timely fashion. Reviews and analyzes significant data and statistics in the computer file. Works to ensure that appropriate control systems are in place to monitor the progress of data acquisition and to define new approaches to data management. Periodically assess quality and completeness of database and patients files. Maintains all required records. Serves as a resource in providing statistical information from the database.

Assists in writing research publications. Performs independent literature searches and selects references for final publication. Prepares data and graphics. Assists in presenting study findings to interested groups both inside and outside of the hospital. Works with physicians clinical nurses and patients to identify and screen appropriate candidates for protocols and evaluates criteria for inclusion/exclusion per study protocol. Obtains all necessary approvals patient written informed consent and demographic information required for patient enrollment.

Contacts patients and/or families via written and telephone communications for the purpose of explaining the nature of the study and setting up visits and interviews including the coordination of international patients. Arranges and coordinates scheduling of initial assessment and subsequent assessments if necessary as outlined in study protocol.

Schedules imaging appointments (DSA CTA MRA etc. and other study procedures for human studies. Collects tissue samples as required by active clinical trials. Arranges transport of samples for processing. Collects analyzes and assures the quality of pertinent patient documentation according to established guidelines. Maintains confidential patient files including all correspondence information raw data and followup status of all study patients. Documents and maintains specific protocol information and communications according to the established guidelines of the unit.

Monitors study by gathering information and reviewing materials visiting patients in the study discussing problems and exchanging information with clinical nurses.

Assesses learning needs and educates patients and family as appropriate regarding protocol management and participation in research project.

Organizes project team meetings and prepares the agenda under direction of the principal investigator(s).

Assesses patient participation on a continuous basis in light of ethical considerations. Acts as liaison between patient and other members of the team regarding the research protocol.

Responsible for developing and maintaining a web page for study information in conjunction with the Principal Investigator Administrative Director Marketing and the Research Management Office.

Designing/implementing advertisements for research study recruitment.

Establishes effective working relationships with the project team.

Works closely with Administrative Director for Research to review expenditures on industry or federal clinical trials and ensures clinical trial billings and expected revenue match.
Reconcile and analyze monthly financial statements. Maintain communication channels with hospital grant department and address any administrative or compliance issue in a timely manner.

• Bachelors degree required in a science or healthcare related field Masters preferred
• Exceptional computer skills (including operating systems word processing database electronic mail internet and spreadsheets) required.
• Good command of English language including medical and scientific terminology.
• Exceptional organizational skills and the flexibility to handle multiple tasks and deadline pressures.
• Effective analytical skills.
• Excellent interpersonal/ communication skills.

Hybrid

55 Fruit Street

40

Regular

Day (United States of America)

The General Hospital Corporation is an Affirmative Action 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.

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