Senior Clinical Studies Associate

Responsibilities

• Support the planning, execution, and day-to-day management of clinical studies and projects.
  • Develop study timelines, milestones, and project tracking tools.
  • Cook up study meetings, prepare agendas, document meeting minutes, and track action items to completion.
  • Facilitate communication among cross-functional teams, investigators, CROs and internal and external stakeholders.
  • Support study startup, maintenance and closeout activities.
  • Identify and escalate routine study issues, risks, or delays as appropriate.
• Coordinate clinical documentation and compliance.
  • Draft, update, and maintain clinical study documentation in accordance with regulatory requirements, GCP guidelines and company procedures.
  • Support the development, review, and completeness of study documents, including protocols, study plans, and essential documents for regulatory submissions.
  • Conduct routine clinical data reviews and support data quality activities.
  • Ensure timely filing, quality review, and completeness of Trial Master File (TMF) documentation.
  • Aid in developing and validating case report form (CRF), and data validation activities, including associated training and documentation.
  • Maintain study records and controlled documentation in accordance with quality system requirements and document control procedures.
  • Support audit and inspection readiness activities by ensuring documentation is complete, accurate, and current.
• Support regulatory and IRB activities.
  • Prepare, coordinate, and track IRB submissions and related activities, including initial submissions, continuing reviews, and amendments.
  • Maintain IRB tracking tools, monitor submission timelines, and manage associated documentation and invoices.
  • Support regulatory documentation activities under the guidance of senior team members.
• Contribute to process improvement and operational support.
  • Support updates to SOPs, work instructions, templates, and operational tools as needed.
  • Contribute to continuous improvement initiatives that enhance study execution, compliance, and operational efficiency.

Minimum Qualifications, Education And Experience

• Bachelor’s degree in life sciences or related field (required); advanced degree preferred.
• Minimum 2 years of related clinical research experience; or an advanced degree without experience; or equivalent work experience.
• Working knowledge of Good Clinical Practice (GCP) and applicable regulatory guidelines.
• Attention to detail and ability to manage multiple tasks concurrently.
• Strong organizational and communication/collaboration skills.
• Proficiency with clinical trial management systems and related tools.

Salary

• Dependent upon experience: $71,000 to $96,000