Clinical Research Coordinator

We are currently searching for a Clinical Research Coordinator to provide support services to satisfy the overall operational objectives of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The primary objective is to provide services and deliverables through performance of support services.  This opportunity is full-time, and it is on site in Bethesda, MD.

• Coordinate clinical admissions for research protocols This will include contact with families’ patients, initial discussions of the clinical protocol with patient family guardian, arranging travel, scheduling, and coordinating subspecialty appointments, coordinating admissions data collection clinical and research samples, coordinating with patient parent for release of pertinent medical records to the protocol team at NICHD
• 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
• Monitor electronic medical record system to ensure necessary components are present and complete such as data collection forms, progress notes, participant information forms and diagnostic test completion forms
• Liaison between the study subjects and the investigators concerning any problems or adverse events including out of range vitals, etc.
• Interact with patients, parents, families, nursing staff, physician staff, social worker staff, clerical staff, laboratory staff, and other clinical center professionals
• Serve as an associate investigator on protocols and obtain informed consent from patient parent legal guardian
• Coordinate and maintain research records in accordance with NIH guidelines
• Review patient care orders in CRIS for accuracy and contact the appropriate clinical fellow for any problems identified
• Review laboratory and clinical test results and report results to the attending physicians
• Participate in relevant clinical rounds
• Provide continuity of care to patients enrolled on assigned protocols
• Serve as a resource to patients and families enrolled in research protocols; facilitate communication with referring physician health care provider
• Communicate with the IRB annual reviews of the protocol; assist principal investigators on all matters that relate to communications with the IRB and the Office of the Clinical Director
• Assist clinical and research staff to ensure that Case Report Forms (CRFs) are completed and document changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and other required fields
• Assist researchers with study testing, observations data entry and other duties associated with study sessions
• Assist staff to develop, assemble related documentation, and maintain regulatory binders for all protocols
• Assist researchers to develop, maintain and complete study data collection forms and source documents
• 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
• Schedule and coordinate outpatient and inpatient visits, diagnostic studies, and medical tests
• Update and maintain logs and records of patient and family contacts
• 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

#SOAR

#LI-JR1

Qualifications:

• Ph.D. in Life Sciences, Biology, General Medical and Health Services or a related discipline is preferred, but not required
• Bachelor’s degree in Biology or General Medical & Health Services, minimum requirement
• At least 3 years of related experience

Skills:

• Strong communication skills, both oral and written
• MS Office Suite

Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.

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