Senior Clinical Operations Associate

6 days ago

San Francisco, California, United States Meet Full time
Job Summary

The Senior Clinical Operations Associate will report to the Head of Clinical Operations and will be responsible for assisting in the oversight and management of clinical trial execution. The Senior Clinical Operations Associate will maintain oversight over Contract Research Organizations (CROs) and key study Contract Service Providers (CSPs) to ensure quality conduct of trials and data collection and work closely with study sites/investigators. The Senior Clinical Operations Associate will also work cross-functionally with other groups such as Clinical Development, Chemistry, Manufacturing and Controls (CMC)/Supply Chain, Regulatory Affairs and Project Management.

Key Responsibilities
  • Assist in managing all aspects of clinical trials to ensure that studies are completed on time, within budget, and in compliance with Standard Operating Procedures (SOPs), FDA regulations and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)/Good Clinical Practice (GCP) guidelines
  • Assist with the management of key study parameters (e.g. start-up activities, enrollment, site management, data collection, data reviews, etc) and proactively identify solutions within the clinical team when issues arise
  • Develop and review informed consent forms, case report forms, study manuals, and other clinical trial materials
  • Assist with evaluating, selecting, and managing clinical study sites
  • Assist in the evaluation and management of CROs and other vendors; negotiate and manage contracts/budgets with CROs and other vendors
  • Provide input to and manage project objectives to meet timelines and deliverables
  • Provide routine study updates to the cross-functional operations team
  • Analyze and develop action plans to address issues with investigational sites and/or CROs
  • Assist with creation of study specific tools and manuals to ensure timeliness, standardization and control of data quality
  • Assist in training new team members on study processes, as required
  • Responsible for tracking/maintaining study metrics/progress and updating Team
  • Serve as sponsor primary contact for sites
  • Participate in the analysis and reporting of safety issues, patient care issues, and study design and/or study conduct issues
  • Review and negotiate clinical site study contracts and budgets
  • Plan, coordinate and present at Investigator Meetings and CRO Training meetings as requested
  • Participate in site qualification, initiation, interim monitoring and close-out visits as needed; perform sponsor oversight visits to oversee and evaluate CRO site monitors
  • Support internal and regulatory audits of clinical trial sites and vendors and assist with resolution of audit findings
Requirements
  • Bachelor's degree in a scientific discipline or health-related field
  • Minimum of 2 years experience as a Clinical Research Associate (CRA) in a biopharmaceutical company or CRO
  • Previous experience with oncology clinical trials strongly preferred
  • Experience working on early development trials a strong plus
  • Radiopharmaceutical expertise a definite plus
Skills and Qualifications
  • Knowledge of FDA regulatory requirements and ICH/GCP guidelines
  • Demonstrated proficiency in implementing, monitoring and management of clinical trials, from start-up to close-out
  • Strong organizational skills, ability to prioritize and multi-task
  • Excellent verbal and written communication skills
  • Demonstrated problem-solving and negotiation abilities
  • Ability to work as part of a team/active team participant
  • Capacity to manage up and also roll-up sleeves when necessary
  • Willingness to travel as necessary, consistent with project needs
  • Excellent computer proficiency (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook)
  • Experience with clinical trial databases (e.g., Medidata Rave, InForm, etc.).

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