Clinical Research Coordinator - NF1 Project

GENERAL SUMMARY/ OVERVIEW STATEMENT:

**This position is hybrid offering both onsite and remote work. Details to be confirmed upon hire.

The Saxena Laboratory in the Center for Genomic Medicine at Massachusetts General Hospital (MGH) is seeking a motivated, enthusiastic, experienced candidate to join our research group to assist in an ongoing clinical research study. Our research group investigates the mechanistic basis of sleep and circadian disturbances using cohort studies of healthy individuals and people living with specific disorders. The NF1 Sleep Study aims at understanding sleep-wake patterns in patients with neurofibromatosis type 1 (NF1). There will also be opportunities to contribute to other research projects within the lab, which focuses on genetics, sleep, and circadian rhythms. This full-time opportunity is ideal for someone seeking a rigorous clinical research experience and meaningful patient interaction. You are encouraged to attend workshops, seminars, meetings of their interest and to engage with others outside of the lab for personal and intellectual growth.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• 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

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

• 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

EDUCATION:

• Bachelor’s degree required.

EXPERIENCE:

• 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.

SUPERVISORY RESPONSIBILITY (if applicable):

• 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.