Search Jobs
Study Specialist II
781 Lincoln Avenue San Rafael, CA 94903 US
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.)
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The 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, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Share This Job:
Related Jobs:
About San Rafael, CA
Are you sure you want to apply for this job?
Please take a moment to verify your personal information and resume are up-to-date before you apply.