The Sr. Study Specialist (SS) significantly contributes to or leads tasks related to the oversight of site monitoring, vendor management, and other activities as delegated by the Study Manager or Program Lead (PL). This may include contributing to and/or supporting study related matters that impact study participant safety, data integrity, study timelines, quality, and budget. The Sr. SS will demonstrate a greater level of independence in executing assigned tasks and manage more challenging or complex vendors, sites, regions, including issue escalations from CROs and effective relationship management with Key Principal Investigator(s).
This is a hybrid role, 2 days a week onsite in San Rafael, CA
location: San Rafael, California
job type: Contract
salary: $51.34 - 59.89 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Develop study specific documentation, as delegated by the Study Manager
- Contribute to the oversight of country and site feasibility assessment and site selection.
- Oversight of CRO for IRB/EC related submission/approval activities
- Oversight of essential documents for study life-cycle management
- Develop/Oversee site and investigator training materials
- Present at investigator meetings as assigned
- Ensure accurate and timely study entry and updates to ClinicalTrials.gov
- Facilitate Screening Authorization Forms sign off and oversee tracking, where applicable
- Process documents for signature in DocuSign
- Oversight of Clinical Trial Insurance
- Attend Global Study Operations team, vendor, 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
qualifications:
- BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered.
- Experience in a biotechnology or pharmaceutical company, oversight of external vendors including SOW, budgets, POs, and invoice management (e.g., CROs, central labs, imaging etc.)
- Agility and Proactivity
- Leadership
- Communication and Collaboration
- Study Management and Execution
- Compliance and Quality
- Drug Development and Study Design
- Product and Therapeutic Area Knowledge
skills: Study Planning
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
