GENERAL SUMMARY/ OVERVIEW STATEMENT:
We are seeking amotivated individual for a Clinical Research Coordinator position in the MGHFood Allergy Center (FAC), led by Dr. Wayne Shreffler. The FAC is amultidisciplinary research center whose primary goal is to investigate newtherapeutic modalities for the treatment of food allergies along withcomplementary investigations on the mechanisms and molecular pathways ofallergic disease.
The incidence offood allergy and food-mediated disorders continues to rise in the US. For example, more than 1% of the USpopulation now suffers from peanut allergy, where exposure to peanut allergen maytrigger a severe reaction. Currently, the clinical treatment of IgE-mediatedfood allergies is limited to allergen avoidance and emergency epinephrinetreatment. In the FAC, we are committed to investigating the underlyingpathways and potential therapies for food allergy. There are multiple clinicaltrials on food allergy in the FAC, investigating cutaneous immunotherapy,defining threshold minimum doses, and defining biomarkers of allergic disease.
The primary focus ofthis position is to coordinate clinical trials. The research coordinator wouldbe expected to provide all aspects of protocol management, including screeningfor patient eligibility, data collection, ensuring protocol compliance, adversedrug reaction reports, monitoring subject treatment, laboratory and specimensubmission, and maintenance of accurate and complete clinical research files.
Candidates for thisposition should have a strong interest in clinical research and patient care.This position would be ideal for those candidates interested in gainingsignificant experience in medical research and considering future medical orgraduate studies. To that end, though not formerly within the expected scope ofthe position, the successful candidate will be encouraged to and supportedseeking educational opportunities and academic productivity
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Please note, the functions below are representative of major duties that are typically associated with these positions. Specific responsibilities may vary based upon departmental needs. Similarly, not all duties that have been outlined will be assigned to each position.
- Collects & organizes patient data
- Maintains records and databases
- Uses software programs to generate graphs and reports
- Assists with recruiting patients for clinical trials
- Obtains patient study data from medical records, physicians, etc.
- Conducts library searches
- Verifies accuracy of study forms
- Updates study forms per protocol
- Documents patient visits and procedures
- Assists with regulatory binders and QA/QC procedures
- Assists with interviewing study subjects
- Administers and scores questionnaires
- Provides basic explanation of study and in some cases obtains informed consent from subjects
- Performs study procedures, which may include phlebotomy.
- Assists with study regulatory submissions
- Writes consent forms
- Verifies subject inclusion/exclusion criteria
- Performs administrative support duties as required
A Clinical Research Coordinator II performs the duties of a Clinical Research Coordinator I (above) and may also:
- Maintain research data, patient fields, regulatory binders and study databases
- Perform data analysis and QA/QC data checks
- Organize and interpret data
- Develop and implement recruitment strategies
- Act as a study resource for patient and family
- Monitor and evaluation lab and procedure data
- Evaluate study questionnaires
- Contribute to protocol recommendations
- Assist with preparation of annual review
- May assist PI to prepare complete study reports
- Careful attention to details
- Good organizational skills
- Ability to follow directions
- Good communication skills
- Computer literacy
- Working knowledge of clinical research protocols
- Ability to demonstrate respect and professionalism for subjects' rights and individual needs
The Clinical Research Coordinator II should also possess:
- Ability to work independently and as a team player
- Analytical skills and ability to resolve technical problems
- Ability to interpret acceptability of data results
- Working knowledge of data management program
- Bachelor's degree required, preferably in a health-relatedfield.
- New graduates with some relevant course/project work or those without any prior research experience will be considered for the Clinical Research Coordinator I position outlined above.
- Those with a minimum of 1-2 years of directly related work experience will be considered for a Clinical Research Coordinator II position.
- A Clinical Research Coordinator I does not have any supervisory responsibility.
- A Clinical Research Coordinator II may assist with the training and orientation of new staff members.
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.