Clinical Research Associate
333 W. San Carlos Street, Suite 800 San Jose, CA 95110
Bayside Solutions is seeking a Clinical Research Associate to be part of our Client’ s team in the South Bay. This is an opportunity to work with a local organization focused on the movement of new drugs or devices from conception to FDA approval. Our Client’ s culture is founded on core values that keep them committed to being a collaborative, innovative, honest, and adaptable place to work. They have built a family within the workplace, promote employees from within, provide opportunities for professional development, and encourage their employees to be active in their efforts to impact their surrounding communities.
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.
- An opportunity to join an organization focused on the movement of new drugs or devices from conception to FDA approval.
- Work for a company that is local to the beautiful south bay area.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, vacation/PTO, and 401K
Clinical Research Associate
Summary of Responsibilities:
- Monitoring clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit. This may include the following site visits: qualification, initiation, interim and close out.
- Managing and training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion.
- Managing, preparing, sending, tracking, and returning investigational supplies at individual sites.
- Monitoring and documenting investigational product dispensing, inventory, and reconciliation.
- Monitoring and documenting laboratory sample storage and shipment.
- Monitoring trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities.
- Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues.
- Reviewing data queries and listings, and working with the study centers to resolve data discrepancies.
- Reviewing regulatory documentation for accuracy and completeness, and supporting study centers with regulatory issues.
- Maintaining complete and accurate study files and reviewing files to ensure all appropriate documentation is present.
- Maintaining consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials
- Following Good Documentation Practices, complete Visit Reports and site correspondence in accordance with SOPS
- Other tasks or responsibilities as assigned
Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training and 2 years of prior experience as a Clinical Research Associate preferred.
- Excellent attention to details
- Flexibility with changing priorities
- Excellent organizational skills
- Ability to efficiently perform and prioritize multiple tasks.
- Ability to use independent, professional judgment to identify and take initiative to solve logistical problems
- Effective verbal and written communication skills
- Ability to work effectively on a diverse team
- Ability to work efficiently on the computer, including document retrieval, review, and tracking
- Familiarity with medical and pharmaceutical industry, and related terminology and practices
- Appropriate knowledge of FDA regulations and their practical implementation
- Intermediate proficiency in Microsoft Office applications, including Word, Excel and Power Point
- Ability to maintain travel schedules efficiently and effectively.
- Ability to travel, including air travel, on notice as short as 24 hours, maintaining efficient and effective travel schedules
- Must have availability of a car in good condition, a valid driver' s license, a good driving record, and up-to-date car insurance