Clinical Research Protocol Coordinator

Minimum Education
Bachelor's Degree In health sciences, clinical research or applicable discipline.
Knowledge of the biological or health sciences gained through advanced education (e.g., M.A., M.S., M.P.H., M.S.N., N.P., P.A., Ph.D.) or equivalent training is preferred.
(Required)
Master's Degree (Preferred)

Minimum Work Experience
4 years Applicable work (e.g., research, clinical, interaction with study population, program coordination);

Work requires at least three years of experience implementing and/or overseeing Phase I through Phase III trials to acquire the skills necessary to audit human subject's research.

Health-related, clinical research or clinical care experience as well as broad knowledge of the procedures and policies related to clinical trials research is required

Experience in a clinical research setting with protocols and clinical trials, such as protocol navigation/clinical research regulatory support or other related field (such as quality assurance monitoring; human research subject protection work).

Previous experience with investigator-initiated or pharma-sponsored clinical trials required
(Required)

Required Skills/Knowledge
Knowledge in clinical research; familiarity with databases, data collection and analysis, able to manage multiple responsibilities and activities with close attention to detail, effective interpersonal skills and ability to communicate with a diverse group of individuals.
Must have demonstrable proficiency in MS Office Suite - particularly Microsoft Excel.
Must also have advanced database management skills, familiarity with electronic health records, quality improvement experience and excellent oral and written communication skills.

Required Licenses and Certifications
Internal candidates should possess one of the following research certifications: Certified Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA). .
Certified Clinical Research Coordinator (CCRC) through the Association of Clinical Research Professionals (ACRP) .
Certified Clinical Research Associate (CCRA) through the Association of Clinical Research Professionals (ACRP) .
Certification in Healthcare Research Compliance (CHRC) through the Health Care Compliance Association (HCCA) .
External candidates will be required to obtain a appropriate research certification (e.g., CCRP, CCRC, CCRA or CHRC) within one year of hire .

Functional Accountabilities
Responsible Conduct of Research

• Demonstrates consistent adherence to the standards for responsible conduct of research.

• Complies with and maintains current documentation of all job-related certifications and training

• Maintains and shares intimate knowledge of institutional SOPs, GCP, ICH, FDA and OHRP regulations and guidance

Protocol and Regulatory Development

• Help with protocol design, study implementation, IND submissions, and IRB submissions with local RB and Federal regulations.

• Ensures that clinical research protocols, consent forms, investigator brochures and other clinical research documents to support IND submissions in compliance with applicable regulatory requirements defined by the Code of Federal Regulations (CFR) and guidelines related to IND Applications for investigational study agents, Informed Consent Documents, and Good Clinical Practice and that data collection plans are consistent with regulatory requirements and the protocol objectives.

Regulatory Filing and Reporting

• Help preparing regulatory submissions

• Supports the preparation of INDs for submission to the FDA

• Ensure regulatory integrity of protocols through preparation and submission of the protocol, consent forms, protocol amendments, and annual progress/continuing reviews to the IRB for approval in accordance with regulatory and/or IRB guidelines and in compliance with the sponsor's specific timeline

• Prepare for sponsor audits.

• Work with the clinical research team on the development and preparation of standard operating procedures (SOPs) pertaining to protocol navigation and regulatory writing for the Cell Therapy Research Program.

• Prepare draft documents for senior staff review.

• Initiate and oversee revisions to documents as indicated in corrective and preventive action plans.

• Collaborate with clinical research scientists, Principal Investigators, Research Coordinators, and safety, regulatory, and monitoring entities.

• Coordinate with other offices (e.g., Office of Human Subjects Research Protections,) to integrate and ensure consistency of new/revised documents with policies

Program Coordination

• Collaborate with clinical research scientists, Principal Investigators, Research Coordinators, and safety, regulatory, and monitoring entities.

• Coordinate with other offices (e.g., Office of Human Subjects Research Protections,) to integrate and ensure consistency of new/revised documents with policies

• Prepares plans and recommendations for any identified necessary changes.

Quality Assurance

• Responsible for preparing protocol documents and required regulatory forms in order to obtain institutional and regulatory agency approval for the conduct of the more complex clinical research projects

Analysis

• Analyze and prepare performance measures and outcome metrics.
• 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