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Senior Clinical Operations Associate

2 months ago

South San Francisco, California, United States Meet Full time

Position Overview

The Senior Clinical Operations Associate will play a pivotal role in supporting the management and execution of clinical trials. Reporting directly to the Head of Clinical Operations, this position is essential for ensuring the effective oversight of contract research organizations (CROs) and key study collaborators, maintaining high standards in trial conduct and data integrity while collaborating closely with study sites and investigators.

Key Responsibilities

  • Oversee all facets of clinical trials to guarantee timely completion, adherence to budgetary constraints, and compliance with standard operating procedures (SOPs), FDA regulations, and ICH/GCP guidelines.
  • Manage critical study parameters, including start-up activities, patient enrollment, site management, and data collection, while proactively addressing challenges within the clinical team.
  • Develop and assess essential clinical trial documents such as informed consent forms, case report forms, and study manuals.
  • Assist in the selection and management of clinical study sites, ensuring optimal performance and compliance.
  • Evaluate and oversee CROs and other vendors, including contract negotiations and budget management.
  • Contribute to project objectives to meet established timelines and deliverables.
  • Provide regular updates to the cross-functional operations team regarding study progress.
  • Analyze issues related to investigational sites and CROs, formulating actionable plans for resolution.
  • Support the creation of study-specific tools and manuals to enhance data quality and standardization.
  • Facilitate training for new team members on study processes as necessary.
  • Track and maintain study metrics and progress, ensuring timely updates to the team.
  • Act as the primary contact for study sites on behalf of the sponsor.
  • Engage in the analysis and reporting of safety concerns, patient care issues, and study design or conduct challenges.
  • Review and negotiate study contracts and budgets with clinical sites.
  • Coordinate and present at Investigator Meetings and CRO Training sessions as required.
  • Participate in site qualification, initiation, monitoring, and close-out visits, providing oversight for CRO site monitors.
  • Support internal and regulatory audits of clinical trial sites and vendors, assisting in the resolution of audit findings.

Qualifications and Experience

  • Bachelor's degree in a scientific or health-related field.
  • A minimum of 2 years of experience as a Clinical Research Associate (CRA) within a biopharmaceutical company or CRO.
  • Experience with oncology clinical trials is highly preferred.
  • Prior involvement in early development trials is advantageous.
  • Expertise in radiopharmaceuticals is a significant plus.

Skills and Competencies

  • In-depth knowledge of FDA regulatory requirements and ICH/GCP guidelines.
  • Proven ability to implement, monitor, and manage clinical trials from initiation to closure.
  • Strong organizational skills with the capacity to prioritize and manage multiple tasks effectively.
  • Exceptional verbal and written communication abilities.
  • Demonstrated problem-solving and negotiation skills.
  • Ability to work collaboratively as part of a team while also being proactive.
  • Willingness to travel as required by project needs.
  • Proficient in Microsoft Office Suite and clinical trial databases.