Clinical Research Associate II
4300 Hacienda Dr Pleasanton, CA 94588
Bayside Solutions is seeking a Clinical Research Associate II to be part of our client’ s team in the East Bay Area. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
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
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Participates in the design, planning, implementation and overall direction of clinical research projects; May co-ordinate the activities of relevant colleagues within the Company and external parties to ensure compliance with the overall scientific study objectives. May work with international investigators and key customers as well.
- Travels to field sites to monitor studies.
- Receives general instructions; plans and prepares studies.
- Reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents
- Works with Data Management and Biostatistics staff on the design of documents and processes for the collection of study data from participating sites.
- Collects and maintains legal and regulatory documentation, as applicable.
- Assumes responsibility for training and coordinating certification of study site personnel.
- Ensures accurate and complete study management/data collection and transfer to data management
- Ensures site compliance with regulations and study protocol.
- Monitors the sites and provides technical assistance, as necessary.
- Assists, prepares and manages study timelines
- Manages material logistics for the studies.
- Conducts reference material testing in-house.
- Organizes investigator meetings, as necessary.
- Participates in Project Team Meetings.
- Keeps informed of trends and developments in clinical research.
- Knows and effectively uses the broad concepts of a particular field or specialization to resolve problems of limited scope and complexity.
- Analyzes alternative approaches to solve problems or develop new perspectives on existing solutions.
Summary of Qualifications:
- Bachelor degree in scientific discipline or related field required, or equivalent combination of education and work experience.
- 2+ years of experience in clinical study coordination, clinical site monitoring or clinical study management is required, 5+ preferred.
- Prior experience with current Good Clinical Practices (cGCP) and Code of Federal Regulations (CFR) is preferred.
- A background in biomedical/healthcare services with laboratory experience preferred.
- Excellent time management skills.
- Ability to give presentations and teach others.
- Ability to work effectively in a team, and also work independently on assigned tasks
- Excellent skills in basic computer applications (Word, Excel, Access, PowerPoint).
- Excellent writing and verbal communication skills.
- Well organized and detail oriented.
- Impeccable record keeping and filing skills.
- Travel Requirement: Approximately 30% of time travel domestic and/or international.