Clinical Research Coordinator
Massachusetts General Hospital(MGH)

Job Info

---

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The Tobacco Research and Treatment Center in the Department of Medicine at Massachusetts General Hospital (MGH) seeks to hire a part-time Clinical Research Coordinator to help conduct a clinical trial of cytisinicline, which is a medication being tested as a possible future pharmacotherapy to help people who smoke to stop smoking. The trial, named ORCA-OL, is funded by the manufacturer, Achieve Life Sciences. This open-label study plans to enroll subjects who have participated in previous cytisinicline studies at MGH (ORCA-2 and ORCA-V1) and who were either not successful at quitting or have relapsed back to smoking after the study ended. The study population will include subjects who are current daily cigarette smokers and/ or daily e-cigarette users and who plan to make another quit attempt during the study. Participants will take cytisinicline for up to 1 year and be followed monthly to assess the safety and effectiveness of the drug for smoking cessation.

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.

Job responsibilities include the following tasks:

§ Serve as a study coordinator for the ORCA-OL Cytisinicline 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 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 searches, and coordinating and scheduling meetings.
Training, Qualifications 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 is preferred.

§ 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 database, spreadsheet, 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 make a 1-year commitment

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.

Qualifications
EDUCATION:

• Bachelor's degree required.

.

EEO Statement
Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.

---