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Study Specialist II

San Rafael, CA 94903

Posted: 03/28/2024 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 600927 Is job remote?: No Country: United States

Job Description


Responsibilities include but are not limited to:
  • Develop and/or review study specific documentation, as delegated by the Study Manager
  • Contribute to the management of country and site feasibility assessment
  • Provide support in the management of Regulatory document collection and tracking (in the absence of a CRO) for participating sites
  • Contribute to the collection and oversight of essential documents for study life-cycle management
  • Contribute to the development of site and investigator training materials
  • May present at investigator meetings as assigned
  • Ensure timely study entry and updates to ClinicalTrials.gov
  • Ensure investigator payment: site set-up, pass-through processing, visit payment processing and funding processing (in collaboration with payment vendor)
  • Provide administrative assistance with internal and external meetings including investigator meeting(s) as warranted
  • Facilitate Screening Authorization Forms tracking/sign off where applicable
  • Manage various Global Study Operations document translations as applicable
  • Process documents for signature in DocuSign
  • Site management for delegated site(s)
  • Manage and resolve site related issues and risks escalated to our company that can’t be resolved by CRO.?
  • Contribute to identifying risks identification and mitigations
  • Oversee the Clinical Trial Insurance process
  • Support Study Manager to ensure timely delivery and handling of IP to the sites
  • Support Vendor Management
  • Attend internal Global Study Operations team meetings, vendor meetings, and/or Cross-Function Study Execution Meeting(s) as GSO representative and take meeting minutes as requested.
  • Oversee and manage essential documents in the Trial Master File (TMF)
  • Contribute to Global Study Operations risks identification and mitigations.
  • Provide support and administrative assistance with internal and external meetings
  • Assist with filing GSO internal study documents in internal systems

The Study Specialist II (SS-II) contributes to or leads tasks related to the oversight of site monitoring, site management and/or vendor management, and other activities as delegated by the Study Manager. This may include contributing to and/or supporting study related matters that impact study timelines, quality, and budget. Within the role the candidate is expected to show and have proficient knowledge and experience in the following competencies:

Core Competencies:
  • Agility and Proactivity
  • Communication and Collaboration

Technical competencies:
  • Study Management and Execution
  • Compliance and Quality
  • Drug Development and Study Design
  • Product and Therapeutic Area Knowledge

Education & Experience
  • BS or higher in nursing, life or health sciences is preferred 
    • Industry or relevant experience in lieu of education may be considered
  • Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)

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 and The Planet Group of Companies are equal opportunity employers. 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 San Rafael, CA

Ready to take the next step in your career? Explore our job opportunities in the vibrant San Rafael, California area! Nestled in Marin County, San Rafael offers a perfect blend of picturesque landscapes, cultural attractions such as the Marin Veterans' Memorial Auditorium and the Marin History Museum, and a thriving culinary scene with diverse eateries like Sol Food and Terrapin Crossroads. This charming city also boasts easy access to outdoor adventures at China Camp State Park and opportunities to appreciate local art at the Falkirk Cultural Center. Join us in San Rafael, where career growth meets undeniable charm – apply now and discover your next career move in this dynamic region!

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.