Senior Clinical Research Associate - Boston, MA
A highly successful pharmaceutical corporation is seeking to hire a Senior Clinical Research Associate for its biopharmaceutical hub. This Institute prides themselves on being proactive and hands-on at the site level.
Senior CRA Responsibilities:
- Review investigational site and CRO performance deliverables, study data, and metrics to determine potential study risks, demonstrate appropriate KRI study oversight, and confirm adherence to applicable regulations.
- Review study and investigational site eTMF files for completeness and appropriate document completion.
- Communicate identified general study or investigational site risks internally and to the CRO.
- Provide guidance to CROs for issue resolution, protocol interpretation, and study execution.
- Communicate and interact with sites and CRO CRAs to identify and address subject enrolment issues.
- Assist in the selection and recruitment of investigational sites
- Collect and review essential documents for study start-up
- Prepare and/or contribute to Clinical Monitoring and Co-monitoring plans
- Perform on-site monitoring (pre-study, initiation, routine, and close-out visits) at clinical study sites to assure adherence to GCPs, SOPs, and study protocols
- Provide Oversight CRO CRAs in the field, evaluating their performance according to the Project Work Order, Monitoring Plan, and source document verification (SDV)
- Assist with and support data validation and data collection procedures
- Assure regulatory compliance of investigational sites with FDA and ICH guidelines
- Ensure documents remain current during the course of the trial
- Contribute to the internal trial master file and assist with inventory to ensure inspection readiness
- Communicate with study site personnel and CRO CRA to resolve data queries
- Experience with Clinical Monitoring Report review.
- Previous experience addressing escalated investigational site issues to resolution.
- Demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations.
- Demonstrated ability to work independently and on a team.
- Proficiency with MS Office (Word, Excel, PowerPoint, and Outlook) and clinical trial software.
- Excellent oral and written communication skills and strong organizational abilities.
- Travel will be required by team/study need (up to 20%).
- Requires a BSN, RN, or BS/BA degree in the life sciences or a health-related field and two or more years of routine monitoring experience in multiple therapeutic areas Bottom of Form
If you or a Clinical Research Associate you know feel this could be an opportunity you would like to explore please send your most up to date resume to myself at Sara.Shields (at sign) Realstaffing.com to discuss this role.
Sthree US is acting as an Employment Business in relation to this vacancy.