Randstad Life Sciences US
Sr. Study Specialist, Global Study Operations (HYBRID)
Randstad Life Sciences US, San Rafael, California, United States, 94911
Overview
Sr. Study Specialist, Global Study Operations (HYBRID) role at Randstad Life Sciences US. The Sr. Study Specialist 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
Good Clinical Practice (GCP), CRO Oversight, Electronic Trial Master File (eTMF), Global Trials, Training Materials
Benefits & Equity
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. We welcome applicants of all abilities. If you require a reasonable accommodation, contact HRsupport@randstadusa.com.
Notes
Pay offered to a successful candidate will be based on factors including education, work experience, location, job duties, and certifications. Randstad offers a comprehensive benefits package where eligible, including medical, prescription, dental, vision, AD&D, life insurance, short-term disability, and a 401K plan.
Additional
This posting is open for thirty (30) days. Qualified applicants in San Francisco and other regions will be considered in accordance with applicable state and local laws, including fair chance ordinances.
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Sr. Study Specialist, Global Study Operations (HYBRID) role at Randstad Life Sciences US. The Sr. Study Specialist 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
Good Clinical Practice (GCP), CRO Oversight, Electronic Trial Master File (eTMF), Global Trials, Training Materials
Benefits & Equity
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. We welcome applicants of all abilities. If you require a reasonable accommodation, contact HRsupport@randstadusa.com.
Notes
Pay offered to a successful candidate will be based on factors including education, work experience, location, job duties, and certifications. Randstad offers a comprehensive benefits package where eligible, including medical, prescription, dental, vision, AD&D, life insurance, short-term disability, and a 401K plan.
Additional
This posting is open for thirty (30) days. Qualified applicants in San Francisco and other regions will be considered in accordance with applicable state and local laws, including fair chance ordinances.
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