Clinical Research Coordinator/Multi-site Clinical Protocol Manager
PROGRAM DESCRIPTION
The Division of Intramural Research conducts over 180 clinical trials spanning clinical areas such as hematology, cardiology, and cardiac imaging, pulmonary, sickle cell disease, and vascular medicine. We are seeking an exceptionally talented, knowledgeable, and motivated individual for a Clinical Research Coordinator position to support the our Applied Precision Omics program with a focus on organ rejection in patients undergoing lung transplantation. In this position, you will play a critical role in the various protocol development, implementation, data management, and evaluation activities. You will also serve as a crucial part of a dynamic team for several simultaneous research projects and studies.
ROLES & RESPONSIBILITIES
• Assists with design, planning and development of new clinical trials and multi-site projects.
• Responsible for critical aspects of study management from startup to closeout. Responsible for ensuring appropriate conduct of protocols to NHLBI and FDA guidelines, coordinates activities associated with execution of approved clinical trial protocols, ensuring regulatory compliance and adherence of procedures and associated documentation.
• Point-of-contact for all outside sites, centers, and internal study team to field questions, troubleshoot issues, and support study activities. Resource for all study staff to help solve logistical or technical problems impeding study completion. Proactively identifies potential issues and addresses them appropriately.
• Work with principle investigator to serve as a liaison between multiple sites to coordinate the day-to-day clinical research operations and data abstraction. Assess research progress through patient enrollment, sample collection and other research procedures.
• Interact with Institutional Review Board (IRB) staff and principal investigators to ensure regulatory and protocol compliance. Point of contact for routine monitoring visits.
• Coordinate and facilitate the timely completion of protocol-required events. Assures careful acquisition and distribution of specimens. Assures that all protocol required testing has been scheduled and patient visits are scheduled in accordance with protocol guidelines.
• Obtain documents from outside providers or laboratories that are needed as part of the research data. Assesses documentation for discrepancies and ensures that inaccurate or discrepant documentation is addressed in the medical record or other source documents. Participates in process improvement activities to improve documentation.
• Coordinates data acquisition, data repository and quality control and storage. Track data acquisition progress and metrics. Understand different data sources, acquisitions procedures, and data status for different projects. Work closely with data managers and site staff to ensure data accuracy, synthesis, and reporting e.g. team briefs.
• Collaborate with the Principal Investigators, and other clinical research staff in the preparation and submission of regulatory reports. Assist in the maintenance of regulatory documents and obtain signatures (i.e., delegation of tasks logs).
• Review medical records for pertinent information. Verify case report forms.
• Abstract basic data from medical records, process/ship specimens, contact of patients for survival information.
• Order medical records for clinical trial reporting. Ensure patient x-rays, CT scans, MRIs, or other appropriate films are obtained. Ensure required outside slides or pathology samples are received and processed.
• In collaboration with Data Management, resolve queries from sponsors.
BASIC QUALIFICATIONS
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
• Possession of bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree.
• In addition to educational requirements, a minimum of one year previous experience in a clinical research setting.
• Strong communication skills – both written and verbal.
• Ability to work effectively in a hybrid in-person and telework environment.
• Ability to multi-task and respond to shifting priorities. Detail-oriented, strong interpersonal skills, and excellent organization and time management skills.
• Experienced and adept with Microsoft Office products (Excel, Word, PowerPoint), with OneNote, Outlook. Comfortable working with databases.
PREFERRED QUALIFICATIONS
Candidates with these desired skills will be given preferential consideration:
• A Bachelor’s Degree in a related discipline such as chemistry, biology, public health, psychology, etc. preferred.
• Prior project management experience in a clinical setting. PMP and/or SOCRA, ACRP or other clinical research certification preferred.
DETAILS
The role is located on the main NIH campus in Bethesda, Maryland and is bus/bicycle/metro accessible. Some additional details are:
• Employment type: contract, full-time (can be renewed indefinitely)
• Salary: commensurate with education and experience
• Benefits: competitive benefits available!
• Mandatory training needed to be successful in this position is offered and supported!
We strongly encourage applications from Black, Indigenous, and People of Color (BIPOC), people who identify as LGBTQIA+ and non-binary, people living with disabilities, and people from marginalized communities. We are happy to talk further about steps we’ve taken to integrate Equity, Diversity, and Inclusion values into our workplace.