Clinical Project Associate

Clinical Project Associate

Clinical Development / Clinical Operations

Working under supervision, the incumbent assists with pre-study, initiation, interim monitoring, and close-out visits; coordinates clinical site activities to ensure compliance with the protocol and overall clinical objectives; and collaborates across functional groups to ensure efficient management of study activities.

This role works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors, and exercises judgment within generally defined practices and policies when selecting methods and techniques for obtaining solutions. Candidates must meet all requirements of the Clinical Trial Assistant position and have demonstrated proficiency in all relevant areas.

Study Execution & Site Support

• Assists with the conduct of pre-study, initiation, interim monitoring, and close-out visits for clinical studies.

• Coordinates activities of clinical sites to ensure compliance with the protocol and overall clinical objectives.

• Assists with site communication and problem solving, and supports sites with submission of essential documents.

• Provides support to the Clinical Trial Manager/Clinical Trial Lead with study-related tasks to ensure efficient execution of clinical trials.

• May assist in data review and query reconciliation.

• May assist in drafting clinical study protocols, informed consents, project-specific tools, and instructional manuals.

Cross-Functional Coordination & Vendor Management

• Coordinates study-related activities both internally and externally.

• Communicates and collaborates with functional groups to ensure efficient management of study activities.

• Liaises with contract research organizations, vendors, and other suppliers of project support services to ensure study deliverables are met; may manage clinical vendors.

• Provides monthly study updates to the appropriate internal stakeholders as required.

• Assists with the coordination and logistics of team meetings, prepares agendas, and records meeting minutes.

Documentation & Trial Master File

• Collaborates with the Documentation Specialist to set up and maintain the Trial Master File (TMF).

• Ensures collection and review of sites' essential documents and maintains the TMF so that it is complete, accurate, and current throughout the life cycle of the study; assists with TMF archival at study completion.

• Assists with distribution and control of clinical, regulatory, and study-related documents (e.g., protocols, informed consents).

• Maintains internal Clinical Operations databases, document repositories, and all aspects of documentation on department databases/team rooms.

Clinical Supplies & Compliance

• Helps ensure compliance with regulatory and Good Clinical Practice (GCP) requirements prior to shipment of clinical supplies.

• Assists in ordering and maintenance of clinical supplies for sites and the study team.

• Assists with maintenance of the drug inventory system and tracks distribution of clinical supplies to sites or third-party packagers.

General

• Maintains a high level of professional expertise through familiarity with clinical literature and participates in project team meetings.

• Works to project objectives to meet timelines and deliverables.

• Travels as needed (10–20%) to coordinate clinical study activities.

• Performs other related responsibilities as needed to support program objectives.

Qualifications

Education

• Bachelor's degree in a scientific discipline is required.

• RN or BSN degree is highly desired.

• Equivalent experience may also be considered.

Experience

• Minimum of 2 years of experience in the pharmaceutical or medical products industry, pharmaceutical product development, or pharmaceutical formulations development.

• Must meet all requirements for the Clinical Trial Assistant position with demonstrated proficiency in all relevant areas.

Knowledge & Skills

• Knowledge of FDA regulatory, ICH, and GCP requirements is required.

• Demonstrated problem-solving abilities.

• Strong organizational skills.

• Strong written and verbal communication skills.

• Demonstrated interpersonal skills and the ability to work effectively as part of a team.

• Good computer skills, including working knowledge of Microsoft Word, Excel, and PowerPoint.

Success Profile

• Detail-oriented and highly organized, with the discipline to keep documentation inspection-ready at all times.

• Proactive communicator who anticipates site and vendor needs before they become timeline risks.

• Comfortable exercising judgment within defined practices while knowing when to escalate.

• Collaborative team member who thrives in a fast-paced, cross-functional clinical development environment.

ADDITIONAL INFORMATION

Nektar currently anticipates the base salary for the Clinical Project Associate to range from $110,000 to $135,000 for candidates in the Bay Area and will depend, in part, on successful candidate location and qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan, depending in part on company and individual performance and at the Company's discretion. The compensation described above is subject to change and could be higher or lower than the range described based on the market survey data.

Qualifying employees are eligible to participate in benefit programs such as:

• Health Insurance (Medical/Dental/Vision)
• Disability Insurance
• Holiday Pay
• Paid Time Off (PTO)
• 401(k) Match
• Employee Stock Purchase Plan
• Wellness Programs
• Parental Leave Benefits (in accordance with the terms of applicable plans)