GENERAL SUMMARY/ OVERVIEW STATEMENT:
We are seeking a bright and motivated individual for a Clinical Research Coordinator position in the MGH Food Allergy Center (FAC)'s infant food allergy division, led by Dr. Michael Pistiner. The infant program's primary goal is prevention of food allergy. The incidence of food allergy and food-mediated disorders continues to rise in the US. For example, more than 1% of the US population now suffers from peanut allergy, where exposure to peanut allergen may trigger a severe reaction. Currently, the clinical treatment of IgE-mediated food allergies is limited to allergen avoidance and emergency epinephrine treatment. In the FAC's infant division, we are committed to investigating the epidemiology of infant food allergy, underlying pathways for food allergy development, characterization of anaphylaxis, and implementation of clinical prevention strategies in primary and specialty care settings.
The primary focus of this position is to coordinate the research and health care provider education aspects/elements of a clinical prevention program. The research coordinator would be expected to provide all aspects of protocol management, including screening for patient and provider eligibility, data collection, data entry, ensuring protocol compliance, adverse drug reaction reports, monitoring subject treatment, scheduling patient visits, laboratory and specimen submission, and maintenance of accurate and complete clinical research files. The research coordination will also participate in the creation and dissemination of healthcare provider and family education material.
Candidates for this position should have a strong interest in clinical research, patient care, quality improvement, and working with infants and their families. Prior clinical experience as an EMT, volunteer work in a clinical setting, medical or nursing assistant, and/or as a medical scribe is preferred. This position would be ideal but not limited to candidates interested in gaining significant experience in medical research and considering future medical or graduate studies. To that end, though not formerly within the expected scope of the position, the successful candidate will be supported in seeking educational opportunities and encouraged to contribute to academic productivity. A two-year commitment to the position is preferred with flexibility.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Ensures protocol implementation and adherence
Recruits, screens, and enrolls subjects for clinical trials
Performs study procedures
Obtains patient study data from medical records, physicians, etc.
Documents and enters data from patient visits in real time
Schedules study visits and assists with scheduling consults
Verifies subject inclusion/exclusion criteria
Collects and organizes patient data
Reports adverse events
Maintains records and databases
Uses software programs to generate graphs and reports
Verifies accuracy of study forms and updates study forms per protocol
Maintains regulatory binders
Writes consent forms and protocol summaries for IRB submission and approval
Submits study documents for regulatory review
Assists with monitoring and evaluating protocol compliance
Participates in monitoring visits and makes corrections as required by monitor.
Acts as a study resource for patient and family
Performs administrative support duties as required
Careful attention to details
Good organizational skills
Ability to follow directions
Good communication skills
Ability to work independently and as a team player
Working knowledge of clinical research protocols and good clinical practice (GCP)
Ability to demonstrate respect and professionalism for subjects' rights and individual needs
Ability to effectively use REDCap is advantageous
Prior experience with EPIC (electronic medical record system) is advantageous