Study Specialist II
American Cybersystems, Inc.

Job Info

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Innova Solutions is immediately hiring for an Study Specialist II,

Position type: Full time Contract
Duration: 7 months
Location: San Rafael, CA

As an Study Specialist II, you will:

Summary:
Hybrid role - will need to be local to come onsite as needed.

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

Skills:

• 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:

• 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.)

Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.
Thank you!
SWEEKRITI KESHARI
Associate - Recruitment
(+1) 213-929-5182
Sweekriti.Keshari@innovasolutions.com

PAY RANGE AND BENEFITS:
Pay Range*: $50 - $60 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:

• One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
• ClearlyRated® Client Diamond Award Winner (2020)
• One of the Largest Certified MBE Companies in the NMSDC Network (2022)
• Advanced Tier Services partner with AWS and Gold with MS

Website: https://www.innovasolutions.com/

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.

This job has expired.