Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills perspectives and ideas we choose to lead. Applications fromprotected veterans and individuals with disabilities are strongly encouraged.
GENERAL SUMMARY/ OVERVIEW STATEMENT:
The Coordinator will be part of a cohesive team within Pediatrics and will provide research support to the clinical investigator. Responsibilities include working independently on IRB submission; site initiation visits; recruitment and retention of study participants; completion of data forms and record maintenance through study close out.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Develop and implement recruitment strategies and enroll qualified patients into clinical trials.
- Independently operate and collect data from subjects medical records
- Perform study procedures which may include phlebotomy collection of vitals structured interviews and other patient assessments
- Obtain patient study data from medical records physicians etc. using HIPAA guidelines
- Process and ship blood and buccal samples according to study and safety protocols. Educate subjects and family as appropriate regarding protocol management and participation in research project.
- Maintain confidential subject files including all correspondence information raw data and followup status of all study subjects.
- Document and maintain specific protocol information and communications according to the established guidelines.
- Review data forms for accuracy legibility completeness and ambiguity.
- Understand and follow IRB guidelines.
- Write review and revise as needed the applications to IRB and the patient informed consent form.
- Prepare and submit IRB documents (i.e. Informed Consent forms modifications adverse events protocol amendments safety reports etc).
- Prepare regulatory documents for sponsor.
- File adverse events with IRB.
SKILLS/ABILITIES/COMPETENCIES REQUIRED:
Exceptional attention to detail; excellent organizational skills and ability to follow directions. Excellent communication skills; ability to work independently and as a team member. High degree of computer literacy; knowledgeable in Microsoft Office Suite and data management programs. Working knowledge of clinical research methodologies and procedures
BA/BS required preferably in neuroscience psychology biomedical engineering or healthrelated field. Masters Degree preferred.
Minimum of 12 years of related experience required.
Office; Outpatient clinic
EDUCATION:
BA/BS required preferably in neuroscience psychology biomedical engineering or healthrelated field. Masters Degree preferred.
EXPERIENCE:
Minimum of 12 years of related experience required.
Required Experience:
Chief