Clinical Research Coordinator with Strong Soft Skills

Job Title: Clinical Research Coordinator with Strong Soft Skills

Job Number: 90624

Location: Washington, DC, US

Job Description

With compassion and expertise, the Clinical Research Coordinator supports families during an unimaginably difficult time by guiding conversations about donating their child’s brain to science. This position requires extraordinary emotional intelligence, organizational precision, and a commitment to ensuring seamless coordination between families, autopsy teams, pathology, scientists, and funeral services. Your work will directly contribute to groundbreaking discoveries in pediatric brain tumor research and honor the legacy of these young lives.

Responsible Conduct of Research

Consistently demonstrates adherence to the standards for the responsible conduct of research.
Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator.
Stays informed of and adheres to institutional policies and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidance (International Counsel on Harmonization) regarding human subjects research and use of protected health information.
Uses research funds and resources appropriately.
Maintains confidentiality of data as required.
Meets all annual job-related training and compliance requirements.

Research Administration

Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility.
Accurately creates, completes, maintains and organizes study documents.
Accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives.
Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned.
Reviews current literature to obtain information relevant to clinical research program, as directed.
Attends study meetings, which could include overnight travel, as requested by principal investigator.
Works well with other members of the research team and seeks and provides input when appropriate.
Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies and the Clinical Research Center.

Participant Enrollment

Employs strategies to recruit and retain research participants, while adhering to the IRB-approved recruitment plan.
Screens subjects for eligibility per the protocol and institutional policies.
Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies.
Independently coordinates, conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs for minimal risk studies or for other studies under direction.
Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest.
Engages participants/LARs in the informed consent process according to institutional policies.
Follows procedures for documentation of study payments and participation incentives.

Study Management

Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member.
Ensures regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB and other oversight bodies in accordance with federal regulations, sponsor SOPs and institutional policies.
Collects, prepares, processes, ships and maintains accurate inventory of research specimens, and trains others in performing these tasks.
Suggests improvements to specimen handling processes, when needed.
Authors study documents, including informed consents, protocol-specific source documents and IRB contingency responses.
Registers and records participant visits in the appropriate tracking system.
Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner.
Coordinates, prepares for and responds to routine oversight body visits and audits.
Performs query resolution and assists with addressing and correcting audit findings.

Data Collection

Collects data from patient medical records, interviews, questionnaires, diagnostic tests and other sources.
Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC: Attributable, Legible, Contemporaneous, Original, Accurate and Complete).
Ensures that queries are resolved within sponsor and institutional timelines.
Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation.
Ensures secure storage of study documents.
Anticipate and responds to customer needs; follows up until needs are met

Teamwork/Communication

Demonstrate collaborative and respectful behavior
Partner with all team members to achieve goals
Receptive to others’ ideas and opinions

Application Deadline: 2025-06-27