Clinical Research Associate II
Redwood City, CA | Contract
Bayside Solutions is seeking a Clinical Research Associate II to be a part of our Client’ s team in Redwood City. Our partner is a biopharmaceutical company focused on the discovery, development and commercialization of medicines for patients with conditions that are often overlooked and undertreated.
The Clinical Research Associate II will participate in study start-up process including; review and development of study-related documents and tools (CRFs, Clinical Study Protocol, ICF, manuals, instructions, etc). The team is a highly-collaborative team and someone that is a proactive problem solver would be the best fit.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Clinical Research Associate II
- The opportunity to work with a company that has products in the development pipeline, as well as a successful marketed product.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, dental, vision, sick time, and 401K benefits.
Summary of Responsibilities:
- Track study metrics; in the absence of automated tracking tools, develop tracking tools and processes that increase measured efficiencies of the clinical study.
- Participate in co-monitoring with CRO' s CRAs.
- Perform remote risk-based monitoring of clinical trial data.
- Review of monitoring visit reports prepared by CRO and ensuring that all identified issues are being followed until resolution.
- Ensure appropriate documentation of all site- and protocol-related issues.
- Support and work with CTAs, ensuring TMF is complete and properly maintained.
- Assist in site selection, study implementation and ongoing management of study sites.
- Coordinate and/or participate in Investigator meetings.
- Train study coordinators and investigators on GCP/ICH and internal processes.
- Bachelor or higher degree in science, nursing, or equivalent with 2+ years’ of experience in clinical site monitoring as a CRA.
- A strong working knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
- Knowledge of electronic TMFs.
- Prior experience with FDA/Health Authority GCP audits/inspections is preferred.
- The ability to execute multiple tasks in a fast-paced, changing environment, and adherence to timelines.
- Good organizational, communication, and teamwork skills.
- Proactive, assertive, and creative approach to problem solving.
- Attention to detail and meticulous follow-through.
- Familiarity with pharmaceutical and medical terminology.
- Experience with different EDC platforms.
- Computer proficiency in Microsoft Outlook, Word, Excel, and PowerPoint.