Clinical Operations & Specimen Program Lead

Jobtailor; California (MO); On-site; USD 80,000 - 110,000; Full time

Job summary

Jobtailor is seeking a proactive Project Coordinator for clinical and regulatory affairs support. You will coordinate with product core teams, study managers, and cross-functional groups to organize work packages and schedules.

You will document processes, track issues, lead small teams, and keep stakeholders informed while helping improve processes in FDA/GCP compliant environments. Occasional travel and flexible hours may be required.

Qualifications

• Bachelor’s degree in a related field or equivalent.
• 2+ years in a project-focused environment.
• Proficient with Microsoft Office Suite.
• Ability to perform essential duties with or without accommodation.
• Authorized to work in the United States without sponsorship.
• CAPM certification preferred.
• Experience with Visio or related workflow tools preferred.
• Knowledge of FDA regulations and ICH GCP preferred.
• Willingness to travel up to 10% and work nights/weekends if needed.
• Ability to lift up to 10 pounds occasionally.

Responsibilities

• Coordinate with product core teams, working groups, and stakeholders.
• Manage operational and sample management processes supporting clinical work.
• Divide and organize work into manageable packages and schedules.
• Visualize and document processes.
• Assign tasks, confirm completion, and ensure on-time delivery of goals.
• Lead defined small and medium-sized teams and components of larger projects.
• Schedule meetings and prepare agendas and minutes.
• Liaise between internal and external stakeholders and Exact Sciences team members.
• Organize and share relevant information with stakeholders and team members.
• Manage issues and action items and collaborate to ensure completion.
• Provide communications and updates to stakeholders, management, and team members.
• Support process improvement initiatives within clinical and regulatory affairs.
• Analyze system user needs, identify efficiencies and gaps, and streamline process flow.
• Communicate efficiencies and gaps cross-functionally.
• Manage multiple priorities in a cross-functional matrix environment.
• Support company quality management system policies and procedures and uphold company mission and values.

Skills

Project Management

Operational Management

FDA Regulations

Process Improvement

Cross-Functional Collaboration

Education

Bachelor’s degree in Business Administration, Engineering, Biology, or related field

Tools

Microsoft Office Suite

Visio

Job description

Jobtailor is seeking a proactive Project Coordinator for clinical and regulatory affairs support. You will coordinate with product core teams, study managers, and cross-functional groups to organize work packages and schedules.

You will document processes, track issues, lead small teams, and keep stakeholders informed while helping improve processes in FDA/GCP compliant environments. Occasional travel and flexible hours may be required.