Clinical Research Associate - Onsite
Collabera Inc.
Alameda, CA, USA
USD 40-50 / hour
Posted on Jun 12, 2025
Clinical Research Associate - Onsite
Contract: Alameda, California, US
Salary Range: 40.00 - 50.00 | Per Hour
Job Code: 362827
End Date: 2025-07-11
Days Left: 28 days, 9 hours left
Position Details:
Industry: Medical Devices/Pharmaceutical
Job Title: Clinical Research Associate - Onsite
Location: Alameda, CA 94502
Duration: 06 months [+ Possibilities of extension]
Pay Range: $40-$50/hr
Description:
- This position will include monitoring and oversight of clinical sites to ensure timely and successful execution of clinical studies, resolving study-related discrepancies.
- This position will ensure compliance with protocol and all regulatory policies, procedures, and/or guidelines during clinical studies by training/guidance of investigators/study coordinators, and follow-up of corrective actions.
- Also, will ensure validity of study by identifying/resolving discrepancies and obtaining missing data and may track more routine aspects of a study. of clinical documents, which may include protocols, case report forms (CRFs), memos, correspondence, reports, and other required documents. Also, conduct new CRA orientation, onboarding, and training activities.
Essential Duties and Responsibilities:
- Candidate will proactively identify, and address issues related to study monitoring and clinical site management.
- Track and communicate monitoring and site management updates and issues; escalate monitoring-related study timeline and quality risks to the Clinical leadership.
- Maintain clinical operations processes, new employee onboarding, internal protocol training, monitoring tracking tools and study tools/templates for CRAs and site personnel.
- Manage CROs/vendors for outsourced activities as applicable, including sponsor oversight of relevant functional activities (e.g., study management, monitoring, site management, project master files, and data management).
- Ensure adherence to Good Clinical Practices, Industry standards, standard operating procedures and to all other regulatory and quality standards in conducting Lingo Clinical research and development.
- Operate under minimal supervision and demonstrate a high degree of proficiency.
- Undertake additional projects and tasks as determined by department and organizational needs.
- The successful candidate will demonstrate the ability to work collaboratively across cross-functional teams, including Quality, Compliance, Product Development, and Engineering, etc.
Qualifications:
- Bachelor’s degree-Major/Field of Study- Biology, Health Sciences, Mathematics, Computer Science, or equivalent
- Prior experience in Clinical Research or Clinical Trials and a solid understanding of related processes.
- Quick thinker, adaptable to evolving workflows, and proactive in seeking clarification when needed.
- Think critically, adapt to evolving workflows, and proactively seek clarification when needed. The ideal candidate will also demonstrate creativity in problem-solving and be open to exploring innovative ideas and process improvements.
- Must be able to quickly learn internal processes and demonstrate the ability to work independently with minimal supervision.
- While support is always available, this role requires someone who can take initiative and adapt quickly in a fast-paced environment.
Skills:
- Demonstrated excellence in teamwork, shared mindset for success, stellar interpersonal and communication skills including building rapport with team members, peers, and management.
- Solid understanding and demonstrated experience of the clinical trial process including study design and conduct; clinical data management systems; clinical trial management systems; data analysis; and data reporting and interpretation.
- Must have a demonstrated ability to solve problems with innovative solutions along with strong project management and organizational skills to deliver projects on time and on budget.
- Able to manage numerous projects/conflicting priorities, and to be flexible when priorities change.
- Working knowledge of GCP, Clinical and Regulatory Affairs.
- Flexibility in daily activities.
- Proficient with MS Office Suite.
Job Requirement
- Clinical Research
- Clinical Trials
- Clinical Study
- Site Monitoring
- Site Visit
- Site initiation
- CRF
- Case report forms
- Phase I-IV
- GCP
Reach Out to a Recruiter
- Recruiter
- Phone
- Niharika Shrivastava
- niharika.shrivastava@collabera.com