Clinical Protocol Specialist

Description:

Independently design and develop clinical research protocols for the evaluation of new investigational vaccines.

Contribute to correspondence with FDA regarding investigational vaccines.

Manage reviews and finalization of a variety of protocol-related documents including Informed Consent Forms, Manual of Procedures, Data Collection Forms.

Assist with oversight of vendor and contracted organizations

Execute the overall management of protocol development, maintenance, and completion in collaboration with clinical and regulatory teams.

Responsible for collecting internal quality data, generating reports, and presenting performance milestones.

Assist with development of department SOPs and guidance's

Participate in site selection/activation, study initiation, monitoring or inspection visits, including facility tours, source document compilation and verification.

Collect and summarize study data per sponsor-required timelines.

Track and communicate status of study-level timelines, in close collaboration with clinical, regulatory, discovery, and operational teams.

Support training and compliance with relevant corporate, quality, regulatory, and safety procedures.

Skills:

Clinical research, Clinical trial, Regulatory, GCP, protocol writing, Protocol Implementation, Project Management, Protocol Design, Data management, Data coordination, Clinical data, Irb, Data entry, Vaccine, Phase I, Phase II, Phase III

Qualifications:

• Demonstrated track record in clinical trial protocol design, development and implementation.

• Solid understanding of clinical regulatory guidelines to ensure appropriate, effective conduct of clinical studies.

• Must be proficient in all functions of clinical research implementation processes and conduct.

• Exceptional organizational and record-keeping skills.

• Extensive experience managing multiple clinical trial protocols, CROs, and study sites.

• Familiarity with FDA regulatory requirements for INDs and guidelines for facilitating clinical human subjects research.

Qualities of a Successful Candidate:

• Leadership: You can drive a high-performance culture

• Communication: You have strong oral and written communication skills

• Organized: You’re comfortable juggling many activities and stakeholders, with strong attention to detail

• Perceptive: You spot small issues and proactively resolve them before they snowball into something bigger

• Collaborative: You want to work in a close-knit team environment, but you're also capable of conducting tasks independently

• Resourceful: You find creative ways to overcome challenges

• Committed: You take ownership of your work

• Travel: You are able to travel as necessary (10-20%)

Experience Level:

Expert Level