Sr. Study Specialist, Global Study Operations

job summary: 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, dataintegrity, 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). Within the role, the candidate is expected to demonstrate and have proficient knowledge and experience in the following competencies:

Core Competencies:

Agility and ProactivityLeadershipCommunication and Collaboration Technical Competencies:

Study Management and ExecutionCompliance and QualityDrug Development and Study DesignProduct and Therapeutic Area Knowledge location: San Rafael, California job type: Contract salary: $45.00 - 58.62 per hour work hours: 9 to 5 education: Bachelors responsibilities: Develop study specific documentation, as delegated by the Study ManagerContribute to the oversight of country and site feasibility assessment and site selection.

Oversight of CRO for IRB/EC related submission/approval activitiesOversight of essential documents for study life-cycle managementDevelop/Oversee site and investigator training materialsPresent at investigator meetings as assignedEnsure accurate and timelyOversight of Clinical Trial InsuranceAttend Global Study Operations team, vendor, and/or Cross-Function Study Execution Meeting(s) asOversee and man study entry and updates to ClinicalTrials.govFacilitate Screening Authorization Forms sign off and oversee tracking, where applicableProcess documents for signature in DocuSignContribute to Global Study Operations risks identification and mitigations.

Provide support and administrative assistance with internal and external meetingsEnd?to?end study operational understanding to support across start?up, maintenance, and close?out activities. (in a fast paced- complex clinical trial environment)Proficient understanding of clinical trial lifecycle milestones, critical path dependencies, and inspection?readiness expectations.

Ability to independently work in complex operational workstreams with minimal oversight Systems & Platforms Proficient use of core clinical systems, including: TMF/eTMF systems (quality, completeness, and inspection readiness)EDC experience (operational interfaces, timelines, and dependencies)IRT/IXRS and eCOA/ePRO operational support as applicableTracking vendor milestones, site activities, and KPIsFamiliar with TEAMS and SharePoint PlatformStrong discipline in system accuracy, reconciliation, and data integrity.

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 includingSOW, budgets, POs, and invoice management (e.g., CROs, central labs, imaging etc. #LI-RA1 skills: EDC (Electronic Data Capture), Electronic Data Capture (EDC), Trial Master File (TMF), Electronic Trial Master File (eTMF)

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. job detailssummary$45 - $58.62 per hourcontractbachelor degreecategorylife, physical, and social science occupationsreference53432job details job summary: 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, dataintegrity, 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). Within the role, the candidate is expected to demonstrate and have proficient knowledge and experience in the following competencies:

Core Competencies:

Agility and ProactivityLeadershipCommunication and Collaboration Technical Competencies:

Study Management and ExecutionCompliance and QualityDrug Development and Study DesignProduct and Therapeutic Area Knowledge location: San Rafael, California job type: Contract salary: $45.00 - 58.62 per hour work hours: 9 to 5 education: Bachelors responsibilities: Develop study specific documentation, as delegated by the Study ManagerContribute to the oversight of country and site feasibility assessment and site selection.

Oversight of CRO for IRB/EC related submission/approval activitiesOversight of essential documents for study life-cycle managementDevelop/Oversee site and investigator training materialsPresent at investigator meetings as assignedEnsure accurate and timelyOversight of Clinical Trial InsuranceAttend Global Study Operations team, vendor, and/or Cross-Function Study Execution Meeting(s) asOversee and man study entry and updates to ClinicalTrials.govFacilitate Screening Authorization Forms sign off and oversee tracking, where applicableProcess documents for signature in DocuSignContribute to Global Study Operations risks identification and mitigations.

Provide support and administrative assistance with internal and external meetingsEnd?to?end study operational understanding to support across start?up, maintenance, and close?out activities. (in a fast paced- complex clinical trial environment)Proficient understanding of clinical trial lifecycle milestones, critical path dependencies, and inspection?readiness expectations.

Ability to independently work in complex operational workstreams with minimal oversight Systems & Platforms Proficient use of core clinical systems, including: TMF/eTMF systems (quality, completeness, and inspection readiness)EDC experience (operational interfaces, timelines, and dependencies)IRT/IXRS and eCOA/ePRO operational support as applicableTracking vendor milestones, site activities, and KPIsFamiliar with TEAMS and SharePoint PlatformStrong discipline in system accuracy, reconciliation, and data integrity.

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 includingSOW, budgets, POs, and invoice management (e.g., CROs, central labs, imaging etc. #LI-RA1 skills: EDC (Electronic Data Capture), Electronic Data Capture (EDC), Trial Master File (TMF), Electronic Trial Master File (eTMF)

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.