Clinical Research Coordinator I

GENERAL SUMMARY/ OVERVIEW STATEMENT:

A full-time clinical research coordinator reporting directly to Dr. H. Diana Rosas is needed in MIND clinical translational research program/Center for Neuroimaging of Aging and Neurodegenerative diseases, to work in a multidisciplinary group conducting clinical studies of aging, cognition, and neuroimaging in adults with Down syndrome at risk for Alzheimer disease and/or in Huntington's disease. The incumbent is expected to work both independently and as a team member with other members of the team including investigators, staff, post-doctoral fellows, and students.

The primary responsibilities of the Clinical Research Coordinator will be to manage clinical, basic science, and technology research studies within the laboratory. Working independently under the PI, he or she will be responsible for pre-screening of healthy volunteers and patients, scheduling and recruitment, evaluating study participants, as well as administrative duties related to the careful operation of the study protocol. He or she will assist in spreadsheet management, including maintaining appropriate protocols for data security, access and quality assurance.

He or she will also assist with the coordination of the study, including recruiting and scheduling participants, and the basic setup and acquisition of the experimental sessions in the MRI scanner, including helping setup physiological recording devices, and will help situate and/or accompany and/or conduct scanning (as needed) of the volunteers.

He or she will work independently under general direction of the PI to coordinate research studies as well as to fill a limited supervisory role in the laboratory. He or she will coordinate regulatory and compliance activities and monitor laboratory safety. He or she will work with research staff to coordinate all laboratory activities including administrative tasks, study visits, and data analysis to assure that the laboratory is meeting the general goals and commitments of the PI. This effort will be in the form of weekly meetings with the PI, organizing and setting the agenda for weekly group laboratory meetings.

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.

• Follows procedures laid out by the lab standard operating procedures. Has active and thorough knowledge of all SOPs and executes then as standardized.
• Assists with recruiting and retaining participants/patients for both observational and for clinical trials
• Works closely with study subjects, including patient/caregiver interviews, neuropsychological testing, assistance with obtaining vital signs, EGKs, brain imaging (which may include accompanying participants into the MRI/PET scanner for the duration of the study), and phlebotomy -may involve occasional home visits
• Processes biological samples, ensures appropriate processing, labeling and storage, maintains accurate sample database
• Documents and compiles clinical research data, schedules appointments and procedures, and maintains study databases
• Meets regularly with Principal Investigator(s) to discuss assignments, projects and administrative matters; keeps them informed relative to status of same
• Attends training courses as identified/needed; maintains certifications
• Organizes, analyzes, and summarizes acquired data, using scientific and statistical techniques
• Prepares and presents reports for meetings, grants, manuscripts
• Organizes and/or drafts material for the preparation of research papers, manuscripts, or other documents for publication and/or presentation as appropriate
• Collects & organizes patient/participant data
• Maintains accurate and timely records and databases
• Uses software programs to generate graphs and reports
• Obtains participant/patient study data from medical records, etc.
• Conducts library searches
• Verifies accuracy of study forms
• Updates study forms per protocol; maintains accurate log of up to date forms
• Documents participant/patient visits and procedures
• Assists with the preparation and maintenance of regulatory binders and QA/QC procedures
• Assists with interviewing study subjects/patients
• Administers and scores questionnaires/cognitive assessments
• Provides basic explanation of study and in some cases obtains informed consent from subjects
• Assists with study regulatory submissions, including new and continuing studies
• Writes consent forms
• Verifies subject inclusion/exclusion criteria
• Performs administrative support duties as required
• Prepares for monitoring visits/responding to queries from monitoring visit
• Performs administrative support duties as required.
• Collects & organizes participant/patient data, both clinical and study
• Maintains records and databases
• Uses software programs to generate graphs and reports
• Obtains patient study data from medical records, physicians, etc.
• Conducts library searches
• Verifies accuracy of study forms and assists in monitoring other lab studies
• Updates study forms per protocol
• Documents participant patient visits and procedures accurately and thoroughly
• Assists with interviewing study subjects/patients
• Administers and scores questionnaires
• Administers and scores cognitive tests
• Provides basic explanation of study and in some cases obtains informed consent from subjects
• Performs study procedures, which may include phlebotomy/EKG/Blood processing.
• Assists with study regulatory submissions
• Verifies subject inclusion/exclusion criteria
• Helps train new staff

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
• Works independently to conduct study visits; has supervisory role over new CRC's

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

• Careful attention to details
• Strong Interpersonal skills
• Excellent organizational skills
• Solid Mac or PC computer skills
• Ability to follow directions and ability to work both independently and as part of a team
• Excellent communication skills
• Computer literacy
• Working knowledge of clinical research protocols; understanding of Good Clinical Practice
• Ability to demonstrate respect and professionalism for subjects' rights and individual needs
• Ability to effectively multitask, prioritize multiple projects and handle fluctuating priorities and deadlines
• Flexibility
• Ability to ask for help when needed

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.
• Field of study/additional specialized training: neuroscience, psychology, or premedical science desirable.

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.

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.