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Remote Sr Clinical Research Spec

Roseville, CA 95678

Posted: 04/14/2025 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 618844 Is job remote?: Yes Country: United States

Job Description


Descriptions:

Responsibilities may include the following:
  • Review and reconcile the study trial master file as planned with the study team
  • Support team with FDA BIMO audit preparations
  • Support study team activities to increase site compliance, data quality, and data analysis and reporting
  • Ensure sites are conducting activities per their protocol, local IRB requirements, and executed contract.
  • Frequent communication with the study lead on site status updates as well as internal leadership.
  • Manage clinical study sites by frequent communication with sites to ensure they have the proper documentation and training to begin enrolling subjects, as well as ensure sites are maintaining compliance by enrolling, submitting data, resolving queries, and resolving action items.
  • Must follow company policies, good clinical practices (GCPs), good documentation practices (GDP), and local laws and regulations.

 

What are the top 3 things you are looking for in a candidates experience:
  1. Experience working on clinical research studies
  2. Experience with IDE studies and a good understanding of 21CFR812 FDA IDE regulations
  3. Experience managing sites that participate in a clinical research study

Education Required: Bachelor’s degree or higher education

Years’ Experience Required: 4 years

 
TECHNICAL SKILLS
Must Have
  • 4+ years of Clinical Research experience in medical device industry.
  • Degree in engineering, life sciences, or related medical/scientific field.
  • Proficient knowledge in medical terminology.
  • Proficient knowledge in MS Office Productivity Tools
  • Knowledge of ICH-GCP guidelines
  • Knowledge of IRB and FDA compliance
  • Knowledge of 21CFR 812 Source Data Verification CCRA certification (Certified Clinical Research Association), ACRP, CCRP, SOCRA, or equivalent preferred.
  • Experience with Good Clinical Practice (GCP), ISO14155 and/or regulatory compliance guidelines for clinical trials/data collection.
  • Ability to appropriately apply different standards related to medical devices/ clinical research (SOPs, GCP, ISO, ICH, FDA, MedDev, etc.), as needed.
Highly desired:
  • experience with audits/compliance within clinical/quality/regulatory and regulatory inspections (e.g., FDA – BIMO, Notified Body (Europe)), and ability to support trial master file remediation and BIMO audit prep, working independently with minimal guidance.
  • Ability to incorporate and adhere to applied standard practices and regulatory standards.
  • Clinical Research experience within the medical device industry or pharmaceutical industry.
  • Experience in sponsor-initiated clinical trial experience managing clinical site personnel Experience working with the clinical study lifecycle (e.g., planning, execution, and closeout)

Nice To Have
  • 3rd Party Audit Support
  • accurate data analysis

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Roseville, CA

Ready to take your career to the next level? Explore job opportunities in the vibrant Roseville, California area! Nestled in the heart of Placer County, Roseville offers a perfect blend of urban amenities and natural beauty. With its proximity to Lake Tahoe and the Sierra Nevada Mountains, as well as easy access to cultural attractions like the Roseville Theatre Arts Academy and Blue Line Arts, this region provides a dynamic landscape for professionals seeking growth and inspiration. Indulge in the delicious cuisine at the family-owned restaurants on Vernon Street or catch a game at the beloved All American Speedway. Discover the charm of this bustling city and unlock endless career possibilities. Explore our job listings today and start your journey towards a fulfilling career in the captivating Roseville area!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.