Clinical Research Associate II
Palo Alto, CA
Position: Clinical Research Associates (all levels)
Location: Palo Alto, CA
Length: Contract to Hire
# of Positions: 5
This position requires that you are fully vaccinated for COVID-19 and can provide proof of vaccination, subject to reasonable accommodation.
The Clinical Research Associates have responsibility for managing and monitoring activities, leading to successful execution of In Vitro Diagnostics clinical studies. A CRA proactively identifies and resolves clinical project problems, and participates in process improvement initiatives as needed. The CRA will be engaging with internal and external stakeholders as a member of the Clinical Trial Operations team.
- Responsibility for all elements of study site monitoring such as pre-study, initiation, interim, and close-out monitoring visits of clinical sites.
- Involved in the developing study protocols, reports, and data transfer specs.
- Managing or coordinating all elements of the clinical monitoring process, complying with GCP/ICH guidelines and regulations- such as review of all mandatory essential documents necessary for study initiation to ensure audit ready study files throughout the duration of the study.
- Managing the identifying, selecting and feasibility processes.
- Ensuring the study staff conducting the protocol have received the necessary materials and instructions.
- Preparing accurate and timely trip reports.
- Maintaining and documenting professional communication with the study sponsor, clinical sites, cross-organizational project team and management throughout the duration of the study.
- Helping develop and maintain SOPs.
- Managing material logistics and acting as contact for clinical trial supplies and other suppliers (vendors) as required.
- Ensuring accurate and complete study management/data collecting and transferring to data management
- Assisting, preparing and managing study timelines.
- Familiar with the principles of the assay and/or instrument and "hands-on" experience.
- Actively participating as a member of the cross-organizational project team.
- Maintaining accurate and timely sponsor/site correspondence and communication.
- Preparing and presenting project progress reports, keeping management and team informed.
- Implementing all policies, established procedures, and regulations into daily operations as required. Developing professional expertise via professional and educational opportunities.
- Demonstrating fundamental writing skills- a style that is clear, concise, effective, and well-organized.
- Understands changes in work tasks, situations, and environment as well as the need for change.
- Thriving with little supervision.
- Driving a resolution for project-related issues while prioritizing workload.
- Efficiently and effectively works in a matrix environment, internally and externally.
- An attitude of flexibility, able to adjust to changing needs.
- Strong knowledge of Microsoft Office as well as project management and clinical trials software.
- BS in biological sciences or medical specialty preferred; MS preferred
- Three or more years of experience in clinical research, IVD, CLIA lab
Bonus points if you have:
- Familiarity of regulations (CFR / GCP) and standards (ICH) affecting IVDs
- Site monitoring of IVD device trials or ClinLab assay/instrument background.
- Oncology experience.
- Clinical Laboratory certification (MT, ASCP or equivalent) or certification as a clinical research associate (CCRA).
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Make this your next career move as one of our many long-term contractors or employees!
- Work as our full-time employee with full benefits (Medical, Dental, Vision, Life, STD, LTD, PTO, etc.) - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.
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- 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor
- Voted ‘Best Staffing Firm to Temp For’ three times by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.