GENERAL SUMMARY/ OVERVIEW STATEMENT:

The Center for Rare Neurological Diseases at Massachusetts General Hospital seeks an exceptional candidate for this Clinical Research Coordinator position to implement and coordinate a variety of human research studies, ranging from natural history studies to translational/interventional trials. We focus on single gene disorders where a single gene defect is sufficient to cause disability and suffering. The Center for Rare Neurological Diseases seeks to implement strategies, create partnerships that advance treatments for rare diseases and thereby serve the many unmet needs in the community. The clinical research coordinator will receive training and support from current study staff, as well as guidance and supervision of the Principal Investigator. We seek an enthusiastic candidate who is eager to work collaboratively with other study staff, physician mentors, industry partners, nonprofit advocacy groups, and especially our patients with rare diseases. The position offers significant learning opportunities, the chance to work directly with research subjects during study visits, and exposure to the implementation of a research protocol from start to finish. Our research coordinators are involved in every step of this process, from initial study design to coordination of study visits, data collection, correspondence with the IRB and study sponsors, and eventually data analysis. The ideal candidate is eager to learn, detail-oriented, passionate, and a great team player.

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

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:

* 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 II may assist with the training and orientation of new staff members.