Clinical Research Coordinator II NEUROLOGY HL

Site: The Brigham and Women's Hospital, Inc.

 

Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

 

New budgeted research role

 

Job Summary

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.

 

Qualifications

Education
- Bachelor's Degree Science required