Clinical Research Coordinator I

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

Summary
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.; and maintaining and updating data generated by the study. Candidates who are in the process of completing their bachelor's degree have a six-month grace period from their hire date (up to one year if starting on a per diem basis) to provide degree equivalency verification.

Does this position require Patient Care?
No

Essential Functions
-Reviews proposals for compliance with sponsor and organizational guidelines; verifies that all sponsor requirements are met.

-Recruiting patients for clinical trials and conducting phone interviews.

-Verifies the accuracy of study forms and updates them per protocol.

-Prepares data for analysis and data entry.

-Documents patient visits and procedures.

-Assists with regulatory binders and QA/QC Procedures.

-Assists with interviewing study subjects.

-Assists with study regulator submissions.

 

Qualifications

Education
Bachelor's Degree Related Field of Study required

Licenses and Credentials

Experience
Some relevant research project work 0-1 year preferred

Knowledge, Skills and Abilities
- Careful attention to detail and good organizational skills.
- Ability to follow directions.
- Good interpersonal and communication skills.
- Computer literacy.
- Working knowledge of clinical research protocols.
- Ability to demonstrate respect and professionalism for subjects' rights and individual needs.

 

Additional Job Details (if applicable)

The Tobacco Research and Treatment Center in the Department of Medicine at Massachusetts General Hospital (MGH) seeks to hire a full-time Clinical Research Coordinator I to help conduct a clinical trial testing a possible future pharmacotherapy to assist people who vape nicotine to quit. This study plans to enroll subjects who vape nicotine or use e-cigarettes. The study population will include subjects who currently vape or use e-cigarettes daily and who are motivated to quit.

This position provides an excellent opportunity for those interested in gaining experience in conducting clinical trials and working with patients.  The candidate will work under the supervision of the Center Director and Principal Investigator, Dr. Nancy Rigotti, and project manager Caitlin McCann.  

 Job responsibilities include the following tasks: 
•    Serve as a study coordinator for the research study
•    Collaborate with the principal investigator, study staff, subjects, clinical research organization (CRO), Study sponsor, and Internal Review Board (IRB)
•    Screen potential subjects for study eligibility 
•    Introduce and describe the study to potential study participants 
•    Complete the enrollment process: assist in obtaining informed consent and collect baseline data 
•    Conduct monthly study visits with participants; this includes completing surveys and data forms, measuring vital signs, collecting blood and urine samples, and providing 10 minutes of behavioral support for quitting smoking or quitting vaping.
•    Assist with preparing the forms for submission and obtaining approval from the Internal Review Board (IRB) for the study protocols.
•    Adverse Event reporting
•    Biological sample acquisition (blood, saliva, and urine)
•    ECG administration and measuring and recording of vital signs (BP, pulse, weight)
•    Managing day-to-day clinical trial operations, data collection and management, behavioral counseling, documentation, investigational product dispensing, scheduling, electronic data entry, inventory, and IATA compliance shipping and tracking of biological samples. 
•    Ensure regulatory compliance and good clinical practice across all trial duties
•    Collaborate closely with fellow study coordinators and the assigned study monitor to address and resolve data queries.
•    Serve as a liaison between the clinical trial site, CRO, L