Clinical Research Coordinator (Cellular Therapy) Phase I Clinical Trails

Minimum Education
Bachelor's Degree

Specific Requirements and Preferences
BA/BS degree in a science, technical, health-related field or another applicable discipline .

Minimum Work Experience
1 year

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) .

Functional Accountabilities

Responsible Conduct of Research
1. Demonstrates consistent adherence to the standards for responsible conduct of research.
2. 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.
3. Maintains knowledge and comprehension of assigned research protocols; including study procedures, timelines and eligibility.
4. 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.
5. Cooperates with sponsor, institutional and federal monitoring/ auditing activities. Then, collaborates with study team in formulating responses to findings.
6. Uses and accounts for research funds and resources at his/her performance level. This includes reconciling research subject billing.
7. Reviews and develops a familiarity with the clinical trial agreement, contract or grant award terms to ensure compliance with all terms and conditions.
8. Complies with and maintains current documentation of all job-related training and conflict of interest reporting.
9. Reports good faith suspicions of research noncompliance and/or research misconduct to the appropriate institutional compliance office(s).

Participant Enrollment
1. Adheres to the IRB approved recruitment and enrollment plan.
2. Screens subjects for eligibility per the protocol and institutional policies.
3. Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies.
4. Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose, participation details and to assess participation interest.
5. Engages participants/LARs in the informed consent process according to institutional policies

Study Management
1. 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.
2. 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.
3. Authors study documents, including informed consents, protocol specific source documents and IRB contingency responses.
4. Registers and records participant visits in the appropriate tracking system.
5. Anticipates study needs and subject caseload to meet organizational objectives and deadlines in a timely manner.
6. Works well with other members of the research team. This includes appreciating multiple workplace diversities and seeking and providing input, when appropriate.
7. Coordinates, prepares for and responds to oversight body routine visits and audits.
8. Attends study meetings (which could include overnight travel) as requested

Data Collection
1. 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).
2. Ensures that queries are resolved within sponsor and institutional timelines.
3. Plans and performs (if assigned) research specimen collection, labeling, and storage/shipping. Maintains accurate sample accountability/chain of custody documentation.
4. Ensures secure storage of study documents.

Other Responsibilities
1. Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies, and the Clinical Research Center.
2. Directs the work of a Clinical Research Assistant, as assigned.

Organizational Accountabilities
Organizational Accountabilities (Staff)
Organizational Commitment/Identification

1. Anticipate and responds to customer needs; follows up until needs are met

Teamwork/Communication

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

Performance Improvement/Problem-solving

1. Contribute to a positive work environment
2. Demonstrate flexibility and willingness to change
3. Identify opportunities to improve clinical and administrative processes
4. Make appropriate decisions, using sound judgment

Cost Management/Financial Responsibility

1. Use resources efficiently
2. Search for less costly ways of doing things

Safety

1. Speak up when team members appear to exhibit unsafe behavior or performance
2. Continuously validate and verify information needed for decision making or documentation
3. Stop in the face of uncertainty and takes time to resolve the situation
4. Demonstrate accurate, clear and timely verbal and written communication
5. Actively promote safety for patients, families, visitors and co-workers
6. Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance