Clinical Research Coordinator

Site: The General Hospital Corporation

 

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.

 

 

Job Summary

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

 

Qualifications

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

 

Additional Job Details (if applicable)

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.

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