Sr. Clinical Research Associate
275 Shoreline Drive, suite 100 Redwood City, CA 94065
Clinical Research Associate
Redwood City, CA
**PRIOR SMALL/START-UP EXPERIENCE IS #1 THING!
**1-2 days per week telecommuting/remote to start**
**Must have strong sponsor (pharma or biopharma) experience. Ideally Oncology and/or Hematology Oncology experience, but this is NOT a must have at the moment.
The CRA works with clinical project team members, vendors, and CRO CRA teams to assure that protocol requirements, regulatory guidelines and study timelines are defined and met. The CRA, in partnership with the CPM or designee, will also ensure that Clinical Operations’ leadership team is aware of all monitoring metrics and related site critical issues. This position will review relevant study documents, trip reports, monitoring trends, track monitoring deliverables, and recommend potential solutions to identified issues.
- Supports the set-up and on-time execution of clinical tasks, while ensuring the trial is conducted in compliance with the protocol, SOPs/Work Instructions, ICH-GCP, and applicable regulatory requirements
- Effectively tracks, files and archives study communications, contracts, essential documents, to provide a complete TMF and Sponsor records
- Collates and maintains study metrics for reporting purposes through established clinical study dashboards and trackers; with archiving of reports
- Assists with supporting oversight of vendors/CROs, including invoice processing
- Reviews monitoring trip reports and follow-up of action items to resolution
- May participate in site visits as needed or accompany Sponsor/CRO members for training and support purposes
- Supports preparation and may develop materials related to the training and presentations for CRA training, Site Initiation Visits and Investigator Meetings;
- Develops Clinical Monitoring Plans
- Supports review of or develops monitoring tools;
- In conjunction with Clinical Development/Operations leadership and vendor, develops and tests EDC, IXRS, data analytics and TMF functionality;
- Facilitates CRO CRA project meetings as necessary;
- Provides a key role in problem solving and issue escalation, regarding monitoring issues, with proposed solutions to the CPM or designee, CRO Lead CRA and Director of Clinical Operations.
Education and Qualifications
- Bachelor’ s Degree with minimum 4-5+ years of CRA experience (must be from sponsor or CRO – NO Academia)
- Must have a valid driver’ s license.
- Willingness and ability to travel 25%-35% of the time with some overnight and weekend travel required.
- Demonstrated experience in core and technical aspects of supporting phase 1-3 clinical trials
- Demonstrated willingness to be hands-on and perform tasks within tight turnaround time
- Excellent interpersonal and communication skills
- Success working in a fast-pace matrix environment
- In depth knowledge of PC operating systems; Microsoft Office, including MS Word, MS Excel, MS PowerPoint, MS Project, MS Publisher, MS Outlook, and MS Windows NT,
- Strives to create a dynamic environment, opens to suggestions and experimentation for improvement
- Embraces the ideas of others, nurtures innovation and manages goals to reality
- Sit in front of the computer for an extended amount of time