Clinical Research Coordinator II

GENERAL SUMMARY/ OVERVIEW STATEMENT:

We are seeking a highly motivated and organized individual to work on the clinical research projects in the laboratory of Dr. Andrew T. Chan, Chief of the Clinical and Translational Epidemiology Unit at MGH. The CTEU and the Division of Gastroenterology are research units within the Department of Medicine. The Chan Laboratory's mission is to advance epidemiologic investigation for the translation of discoveries into effective clinical interventions. Specifically, we are looking for someone to assist in our ongoing clinical trials in the prevention and interception of gastrointestinal diseases, including cancers, and other translational projects related to nutrition, the gut microbiome, and health and disease. All of our studies aim to advance our understanding of the molecular basis of disease with a goal of identifying biomarkers for use in precision medicine.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

The selected candidate will work independently to coordinate clinical research projects directly supervised by the principal investigator and other investigators within the CTEU.

Candidate's principal duties and responsibilities will include:

• Navigating clinical interactions with physicians and associated medical teams clinical research staff, and study participants.

• Troubleshooting clinical issues independently with collaborative guidance from colleagues.
• Screening, identifying, and enrolling eligible participants, coordinating patient interactions during study visits, and collecting and processing biospecimens (stool, blood, urine, tissue etc.) critical to the outcome of our trials.
• Soliciting and recording information regarding safety events and preparing safety event documentation for review by the Principal investigator/IRB.
• Assisting in preparing study reports and presentations.
• Managing participant visit scheduling and technical troubleshooting, escalating issues to the appropriate individual(s).
• Assisting senior project manager with organizing team meetings, taking and disseminating minutes.
• Assisting with preparing IRB submissions (amendment, continuing reviews, deviations/violations, AEs).
• Assisting with revising and creating protocols, consent forms and other patient-facing materials
• Creating standard operating procedures (SOPs) and checklists for current and new projects and building RedCap databases.

The Clinical Research Coordinator II will be expected to work full time in-person (40 hours/week) including occasional after or before hours work. There is a possibility that limited weekend work will be required should trial needs arise. The work is expected to focus on the execution of an increasing portfolio of clinical trials including, but not limited to:; feasibility studies of intravenous fluorescent probes that help detect gastrointestinal tumors in a background of normal tissue; several biorepository studies that focus on improving early detection of GI diseases and identifying risk factors contributing to the diagnosis of early-onset colorectal cancer; investigating the role of coffee metabolites in improving survival after colorectal cancer; and understanding the role of the gut microbiome in cancer outcomes. The research environment is conducive to those individuals interested in eventually pursing advanced medical, graduate, or public health advanced degrees, and especially those with an interest in cancer prevention, the gut microbiome, and nutrition.

The position will begin in November 2024.

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

* Excellent interpersonal, verbal and written communication skills.

* Ability to manage time effectively.

* Ability to work independently and as a collaborative team member.

* Train and mentor junior research staff and ensure adherence to study protocols maintaining an inclusive and collaborative culture.

* Experience with creating study protocols/documents and managing IRBs.

* Ability to maintain accurate records.

* Ability to organize, analyze, summarize, and present data.

* Experience in a clinical environment or biobanking preferred.

* Experience in cancer and/or nutrition related research are preferred.

* Experience and proficiency in wet laboratory techniques conducive to biobanking procedures (pipetting, nucleic acid extractions, sterile technique) are required.

EDUCATION:

• Bachelor's degree in Nutrition or Biology, Biochemistry, Immunology or related Pre-medicine discipline required with at least 1 year of related experience; OR M.S. or equivalent in one of these disciplines.

EXPERIENCE:

• 1+ year of biomedical laboratory experience or equivalent clinical research training (internships / undergraduate research)required. This additional laboratory or clinical research experience is expected to have occurred beyond traditional course work.