Senior 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 mission—from doctors, nurses, business people and tech experts, to dedicated researchers and systems analysts. As a not-for-profit 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 second-generation immigrants, veterans, and people from different socioeconomic backgrounds – to apply.

 

 

Job Summary

Under the general direction of the Principal Investigator and Research Nurse Manager, the Sr. Clinical Research Coordinator serves as a lead team member, subject matter expert and trial coordinator. Designs, implements, and coordinates both industry and physician sponsored research trials. This includes acting as a liaison between the Principal Investigator, clinical collaborators, the study sponsor, clinical trial regulatory groups (IRB, FDA, etc.), and other research staff to ensure adherence to the study protocols. Implements the research protocol through study closeout and ensures data validation, regulatory compliance, and quality control.

Facilitates physician initiated trials including protocol development, electronic data capture (EDC) implementation and management, information reporting, and ongoing monitoring of trials. Will ensure all project timelines are met.

 

Qualifications

Principal Duties and Responsibilities:

• Serves as point person and lead for all assigned clinical trials including supporting other team members in study related activities.  Utilizes advanced knowledge of clinical trials to serve as subject matter expert regarding protocols, regulatory compliance and sponsor relations.

• Collaborates with investigators and management to plan, implement, monitor, and coordinate clinical trials and study related activities

• Manages study data, ensuring proper collection methods, data quality, retention by team members.

• Conducts routine and advanced data analysis to identify trends, study direction and action items and for use in regulatory reporting and research publications by the principal investigator.  Prepares reports for study sponsors and investigators to outline progress and support new opportunities in the trial or research.  Prepares ad hoc reports to keep management abreast of the status of studies and operations.

• Participates in the development, implementation, and revision of study related processes, procedures, tools, and training as necessary to improve trial implementation. In conjunction with investigators and management prepares and monitors study budgets, tracks and reports expenses, submits expenses for payment in a timely manner, ensures expenses meet study targets and resolves variances.

Industry Sponsored Trials:

Coordinates assigned industry trials and ensures study goals are met.  Day-to-day study responsibilities include:

• Reviews research subject medical records, abstracts data, completes the case report forms (CRFs), and records the information in the electronic data capture systems (EDC). 

• Maintains meticulous records of all study patients and administers protocol specified questionnaires and assessments.

• Responds to queries and data entry in adherence to study-specific timelines. 

• Interacts with patients enrolled in the research protocols on a regular basis.  This includes ensuring medication compliance in accordance with study/department protocols.

• Attends the study procedure in the OR and/or cath lab/Interventional radiology.  This includes collecting study related data, as well as the delivery, tracking, and if needed return, of the investigational devices.  Communicates and ensures compliance of the study protocol during the procedure.

• Performs activities to support the operational needs to clinical trials to include collecting and shipping of protocol-related lab samples and devices, ensuring investigational devices are ordered, received and securely tracked and ensur