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Senior Clinical Research Associate, Oncology
4 weeks ago
The Senior Clinical Research Associate, Oncology will provide trial support for the initiation, execution, and compliance of clinical studies to support both product approvals and market adoption of company products.
Key Responsibilities- Develop and maintain individual investigator relationships, guiding them on protocol data requirements and reviewing their progress on a regular basis
- Ensure adherence to ICH-GCP and Regulations
- Facilitate scientific discussion on product and protocol requirements
- Monitor, evaluate and resolve all vendor issues
- Drive timelines and provide guidance on all protocol, technology, and data questions
- Train and assist site coordinators, investigators, field clinical staff, CRO (as applicable) in collecting data in a timely manner that meets the protocol requirements and timelines/milestones
- Liaise with study site staff to ensure timely and accurate CRF data
- Conduct Site Evaluation, Site Initiation, Interim Monitoring and Close Out visits
- Serve as first point of contact for site staff
- Administer protocol and study related training to sites
- Monitor clinical sites, assessing any potential discrepancies and working with internal management and clinical site teams to identify and implement resolutions
- Manage device/medication accountability and inventory throughout clinical study
- Monitor study to ensure sites are in compliance with protocol, SOPs and regulations
- Complete accurate monitoring reports and follow up letters in a timely manner
- Review clinical study reports for regulatory submissions and follow up on assigned action items and queries
- Ensure rights, safety and well-being of trial subjects are protected and the data is accurate and verifiable
- Perform source data verification and ensure accuracy and completeness
- Ensure quality of the data by performing regular reviews of data according to data review/monitoring guidelines
- Bachelor's degree in a science-based discipline
- ~5+ years of monitoring experience on clinical trials
- ~Applicable experience in biotech, pharmaceutical and/or medical device industries preferred
- ~Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.)
- In depth knowledge and skill in applying applicable clinical research regulatory requirements (i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Must have knowledge of and direct experience with Microsoft Office: Word, Excel, PowerPoint, OneNote, Outlook, and Adobe Acrobat
- Experience with controlled clinical terminology and clinical trial systems such as TMF/eTMF, CTMS, EDC, IVRS/IWRS, ePRO is highly preferred
This position requires up to 50-75% travel.
