Lead Clinical Research Protocol Coordinator

Minimum Education
B.S. Bachelor of Science (Required)
M.S. Master of Science (Preferred)

Minimum Work Experience
7 years of related work experience in a clinical research setting with protocols and clinical trials, including experience implementing and/or overseeing Phase I through Phase III trials (Required)

Required Licenses and Certifications
CCRP
Upon Hire (Required)

Functional Accountabilities
Duties & Responsibilities

• Consistently demonstrates 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

• Coordinate and assist with all regulatory activities for initial IND Applications, Annual Reports, Amendments & Continual Reviews including protocol review, document compiling, electronic regulatory submission, and timeline tracking.

• Lead and participate in projects to optimize regulatory processes and facilitate best practice approaches to ensure compliance in accordance with GCP, ICH, FDA and other Health Authority regulations and governing bodies.

• Provide oversight for regulatory activities, database management, and ensure that records are complete, accurate, and current for Trial Master Files (TMF).

• Analyze medical research data, ICF's and CRF's to ensure regulatory and protocol compliance.

• Partner with essential project management contacts to uncover and resolve potential issues and deviations from target timelines.

• Identify areas of improvement for work process tools including regulatory templates, SOPs, work instructions, checklists, trackers, etc. and lead the reconfiguration of identified improvement areas.

• Engage with internal executive leadership, high level external stakeholders and project teams to ensure effective communication is delivered with all project members.

• Perform literature research, attend meeting and calls to gain regulatory intelligence, strategy development in order to support regulatory document preparation, submissions and identification of regulatory policy changes.

• Serve as a subject matter expert for federal regulations and state laws governing and impacting human subjects' research.

• 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.

• Prepare plans and recommendations for any identified necessary changes.

• Prepare 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.

• 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