Clinical Research Coordinator I

SummaryFollowing 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?NoEssential 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.

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.

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, Lab, and Sponsor.
* Provide support to the Tobacco Research and Treatment Center as necessary, with duties including taking meeting minutes, performing literature research, and coordinating and scheduling meetings.

Training and Experience:
* B.A./B.S. required
* Prior work experience as a research assistant or coordinator in a clinical and/or academic environment is preferred, especially experience with public health or health behavioral interventions
* Experience in providing tobacco cessation behavioral support and counseling.
* Interest in medicine, health behavior, psychology, or public/community health
* Excellent organizational, communication (oral and written), and problem-solving skills
* Enjoyment and skill in quickly building rapport with a range of prospective participants
* Strong computer skills, experience working with databases, spreadsheets, and word processing programs, and ability to use Microsoft Office (Access, Excel, Word, PowerPoint, and EDC)
* Excellent English language skills (grammar and spelling) are a must. Good telephone and in-person communication skills are also required
* The ideal candidate is a self-starter who works well as a member of a team yet has the ambition and drive to take on tasks independently. He/she must be able to handle and prioritize multiple tasks, have strong organizational skills, and pay close attention to detail
* Willingness to stay within role at least one year given steady funding and performance

Working Conditions:
The position is located at Massachusetts General Hospital, 100 Cambridge Street, Boston, MA. Study visits and procedures will be done at the Richard Simches Building, 185 Cambridge Street, Boston, MA. The position is Monday through Friday (no MGH-observed holidays or weekends required). Occasional flexibility with work hours will be necessary.

The General Hospital Corporation is an Equal Opportunity 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.

Required

Preferred

Job Industries

• Other