Study Specialist II from Innova
San Rafael, CA
About the Job
Innova Solutions has a client that is immediately hiring for Study Specialist II
Position type: Full-time Contract
Duration: 12 months Contract
Location: San Rafael, CA-Hybrid
As a Study Specialist II, you will:
Key Responsibilities:
Global Study Operations organization is tasked with providing strategic direction on the feasibility, design, and conduct of Phase 1-4 and post approval studies and drives the delivery of high-quality data to support the registration approval and post approval activities of our clinical development assets. The organization achieves this through the development and operationalization of Clinical Development Plans, study planning and delivery, cross-functional leadership of Study Execution Teams, operational trial expertise, and vendor management and oversight.
Role Summary 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 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 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 Education & Experience ? BS or higher in nursing, life or health sciences is preferred
Suhail Ahmed
Email: Suhail.Ahmed@innovasolutions.com
Phone – 678-834-8320
PAY RANGE AND BENEFITS:
Pay Range*: $35 - $40 per hour
*Pay range 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.
Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
Recent Recognitions:
Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.
The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws
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Position type: Full-time Contract
Duration: 12 months Contract
Location: San Rafael, CA-Hybrid
As a Study Specialist II, you will:
Key Responsibilities:
Global Study Operations organization is tasked with providing strategic direction on the feasibility, design, and conduct of Phase 1-4 and post approval studies and drives the delivery of high-quality data to support the registration approval and post approval activities of our clinical development assets. The organization achieves this through the development and operationalization of Clinical Development Plans, study planning and delivery, cross-functional leadership of Study Execution Teams, operational trial expertise, and vendor management and oversight.
Role Summary 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 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 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 Education & Experience ? BS or higher in nursing, life or health sciences is preferred
Suhail Ahmed
Email: Suhail.Ahmed@innovasolutions.com
Phone – 678-834-8320
PAY RANGE AND BENEFITS:
Pay Range*: $35 - $40 per hour
*Pay range 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.
Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
Recent Recognitions:
- Named One of America’s Best Employers for New Grads by Forbes (2024
- Named One of the Best Companies to Work For by U.S. News & World Report (Private Companies List, 2024-2025)
- One of the Largest IT Staffing Firms in the US – Ranked #3 by Staffing Industry Analysts (SIA, 2024)
- One of the Largest Staffing Firms in the US – Ranked #13 by Staffing Industry Analysts (SIA, 2024; includes Innova Solutions, Volt, & HireGenics)
- Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023)
- One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC, 2024)
- AWS Advanced Tier Services Partner with 100+ certifications
Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.
The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws
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Salary
$35 - $45 per hour