Participates in or leads day-to-day operations of clinical research studies conducted by a principal investigator. Performs a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. May direct the work of junior staff. Attains progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations, when applicable. Follows procedures for documentation of study payments and participation incentives. Employs strategies to recruit and retain research participants. Assists participants with individual needs. Maintains regulatory documents as per sponsor and institutional policies. Independently coordinates conducts and documents study assessments according to study protocol, operational plans of clinical departments and Standard Operating Procedures (SOPs) for all types of studies. May provide training to personnel. Ensures compliance with protocol guidelines and requirements of regulatory agencies. 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. Prepares for study monitoring or study audit visits. Performs query resolution and assists with addressing and correcting audit findings. Collects data from patient medical records, interviews, questionnaires, diagnostic tests and other sources. Works with sponsor representatives. Reviews current literature to obtain information relevant to clinical research program, as directed.
Specific Requirements and Preferences
BA/BS degree in a science, technical, health-related field or another applicable discipline .
Minimum Work Experience
Specific Requirements and Preferences
1 Year of applicable work, research or internship experience (e.g. research assistant, data manager, clinician or other interaction with a research population) .
Responsible Conduct of Research
- Demonstrates consistent adherence to the standards for responsible conduct of research.
- Stays informed of and adheres to institutional policies, and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidances (International Counsel on Harmonization) regarding human subjects' research and use of protected health information.
- Maintains knowledge and comprehension of assigned research protocols; including study procedures, timelines and eligibility.
- Creates, accurately completes, maintains and organizes study documents. Accounts for study materials. This may include, but is not limited to participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s), and participation incentives.
- Cooperates with sponsor, institutional and federal monitoring/ auditing activities. Then, collaborates with study team in formulating responses to findings.
- Uses and accounts for research funds and resources at his/her performance level. This includes reconciling research subject billing.
- Reviews and develops a familiarity with the clinical trial agreement, contract or grant award terms to ensure compliance with all terms and conditions.
- Complies with and maintains current documentation of all job-related training and conflict of interest reporting.
- Reports good faith suspicions of research noncompliance and/or research misconduct to the appropriate institutional compliance office(s).
- Adheres to the IRB approved recruitment and enrollment 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.
- Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose, participation details and to assess participation interest.
- Engages participants/LARs in the informed consent process according to institutional policies
- 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.
- 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 to meet organizational objectives and deadlines in a timely manner.
- Works well with other members of the research team. This includes appreciating multiple workplace diversities and seeking and providing input, when appropriate.
- Coordinates, prepares for and responds to oversight body routine visits and audits.
- Attends study meetings (which could include overnight travel) as requested
- Assures that data is collected as required by the 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 (if assigned) research specimen collection, labeling, and storage/shipping. Maintains accurate sample accountability/chain of custody documentation.
- Ensures secure storage of study documents.
- Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies, and the Clinical Research Center.
- Directs the work of a Clinical Research Assistant, as assigned.
Organizational Accountabilities (Staff)
- Anticipate and responds to customer needs; follows up until needs are met
- Demonstrate collaborative and respectful behavior
- Partner with all team members to achieve goals
- Receptive to others' ideas and opinions
- 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
- 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