Clinical Research Coordinator

Position Objective: Provide services as a Clinical Research Coordinator in support of the overall functions of the National Institute of Neurological Disorders and Stroke (NINDS) within the National Institutes of Health (NIH). Coordinate the functions necessary for recruitment, scheduling, travel, outpatient admission, and inpatient admission of patients to the Clinical Center, to include acting as a liaison between the patient/family and the ME/CFS/GWI research team, and interaction with the medical staff, nursing staff and NIH consultants.

Duties and Responsibilities:

• Participate in developing and maintaining research protocol documentation and operations. 5

• Verify study participant information and collect data and results of testing.

• Assist staff develop, assemble related documentation and maintain regulatory binders for all protocols.

• Assist researchers develop, maintain and complete study data collection forms and source documents.

• Work with staff on the design, development and preparation of documents such as spreadsheets, letters, rosters, agendas, presentations and meeting minutes/summaries.

• Assist researchers design patient Case Report Forms (CRFs).

• Retrieve research related information from medical records, hospital information system and laboratory information system and create spreadsheets and other reports for use in study analysis.

• Prepare patient charts for clinic days and provide initial or follow-up assessment forms, patient labels, most recent medication lists and lab and procedure printouts.

• Assist staff screen prospective study subjects and participate in scheduling participants for research visits and procedures. 2

• Schedule and coordinate outpatient and inpatient visits, diagnostic studies and medical tests. 1

• Observe data collection and monitoring of withdrawals and assist reporting deviations and adverse events. Update and maintain logs and records of patient and family contacts. 3

• Provide continuity of care to patients enrolled on assigned protocols.

• Assist protocol staff submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.

• Maintain content on the Clinical Studies websites (resources for staff and extramural investigators).

• Update annual status of recruitment/enrollment in NIH Human Subjects Reporting System.

• Participate in coordination and management of most daily activities of the study and ensure that study activities follow established protocol, Standard Operating Procedures (SOP), and utilizes approved forms, templates and practices.

• Assist staff on all facets of clinical studies including subject enrollment, scheduling outpatient appointments and inpatient admissions, travel arrangements, investigation consent, subject longitudinal monitoring, study data, sample collection and data entry.

• Prepare and submit for review accurate source documents related to all research procedures.

• Organize, prepare and distribute informational materials and provide support to the educational mission of the study. Mentor new clinical research coordinators on all aspects of research support. 4

• Work products and documents related to preparation and follow-up of patient admissions, medical records and test arrangements; prepare patient travel documents and make travel arrangements - Ad-Hoc

• Computer generated work including entering admissions information and authorization for hotel and travel through the Admissions Travel Voucher (ATV) system; schedule patient tests and evaluations through use of the computerized Appointment Scheduling System (CAS). - Ad-Hoc

• Work products and documents related to functioning as an information resource for patients who call, e-mail or write, triaging the inquiries to the appropriate protocol staff; train new support personnel. - Ad-Hoc

• Work products and documents related to compiling and consolidating weekly schedules for patients; ensure appropriate distribution; perform management of travel and reimbursement-related aspects of protocol submission and renewal; perform administration of qualitative interviews to research participants. - Ad-Hoc

• Work products and documents related to the scoring and processing of neurocognitive testing of research participants; assist in the planning, administration and coding of the protocol's focus group studies; develop, maintain, and generate reports for an academic level database for tracking recruitment and recruitment outcomes for the protocols - Ad-Hoc

• Work products and documents related to administrative support for the clinic including phone support, scheduling meetings on Webex, maintaining multiple calendars (schedule meetings, etc.), creating and submitting POTS orders, enter receiving in POTS and track orders; order supplies on NBS Internal Requisitioner. - Ad-Hoc

• Work products and documents related to functioning as the POC for shipments, maintenance, housekeeping, etc.; submit maintenance and IT tickets for staff; assist in oversight of shipping in and out of 3B-19 space. - Ad-Hoc Work products and documents related to the preparation of forms, memoranda, letters, Statements of Work and reports using Excel and Microsoft office; develop and maintain files according to NIH/NINDS policies. - Ad-Hoc

• Work products and documents related to contacting study staff to take required training; maintain training database; contact study staff about licensing/certifications for IRB requirements; maintain licensing/certification databases. - Ad-Hoc

• Work products and documents related to creating credentialing packages (new and renewal) for required staff; arrange travel for guest visits to NIH (non-NIH affiliates) for interviews, seminars, etc.; create vouchers - Ad-Hoc

Qualifications

Basic Qualifications:

• Bachelor's degree in business management and administration.

• Skilled in Microsoft Office.

• Experienced in coordinating project meetings, electronic medical records, patient confidentiality, clinical research, recruitment, scheduling, and screening.

Preferred Qualifications:

• Ability to multi-task and pay close attention to detail.

• Excellent analytical, organizational and time management skills.

• Strong communication skills, both oral and written.

* This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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