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. The CRC 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 situateand/or accompany and/or conduct scanning (as needed) of the volunteers. The CRC 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.

The General Hospital Corporation is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.