Clinical Research Coordinator

The Clinical Research Coordinator participates in or leads day-to-day operations of clinical research studies conducted by a principal investigator. The Research Coordinator performs a variety of duties involved in the collection, compilation, documentation and analysis of clinical research data. The Research Coordinator will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations. This position may direct the work of junior staff, train personnel and direct the work of a Clinical Research Assistant as assigned.

The Clinical Research Coordinator will be supporting the Prenatal Pediatrics Institute Research Team.

Minimum Education
Bachelor's Degree B.A./B.S. degree in a science, technical, health-related field or other applicable discipline (Required)

Minimum Work Experience

1 year of applicable work, research or internship experience (e.g. research assistant, data manager, clinician or other interaction with a research population). (Required)

Functional Accountabilities
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

Performance Improvement/Problem-solving

• Contribute to a positive work environment

• Demonstrate flexibility and willingness to change

• Identify opportunities to improve clinical and administrative processes

• Make appropriate decisions, using sound judgment

Cost Management/Financial Responsibility

• Use resources efficiently

• Search for less costly ways of doing things

Safety

• Speak up when team members appear to exhibit unsafe behavior or performance

• Continuously validate and verify information needed for decision making or documentation

• Stop in the face of uncertainty and takes time to resolve the situation

• Demonstrate accurate, clear and timely verbal and written communication

• Actively promote safety for patients, families, visitors and co-workers

• Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance