Sr. Clinical Trial Specialist
American Cybersystems, Inc.

Job Info

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Innova Solutions has a client that is immediately hiring for Sr. Clinical Trial Specialist.

Position type: Fulltime - Contract

Duration: 2 Months

Location: Remote

As Sr. Clinical Trial Specialist,you will:

Job Description:
Responsibilities:

• Actively involved in the performance of study feasibility assessments
• Develop and review study documents (e.g., site instructions, diaries, lab manual, Pharmacy Binder, Study Management Plan, etc.) and clinical site documents (e.g., site specific informed consent forms)
• Manage the collection, review and approval of regulatory documents from clinical sites
• Coordinate investigational product release activities across clinical sites
• Initiate, maintain and reconcile the Trial Master File
• Assists in the preparation of Investigator and Study Coordinator Meetings
• Set up and maintain tracking systems (e.g., CTMS), tools and report study metrics to support the clinical trial programs
• Manages and tracks study specific payments
• Coordinate communication of tracking information within the study team and to the clinical sites
• Develop and review Standard Operating Procedures
• Serve as a subject matter expert for the CTS role on initiatives and working groups
• Mentor Clinical Trial Associates and peer CTSs, including the onboarding of new hires

May be responsible for the following activities:

• Manage ancillary vendors, such as a specialty lab or central lab o Assist with training the Clinical Research Associates
• Perform site initiation, routine monitoring and close out visits at a limited number of clinical sites, as well as co monitoring with Clinical Research Associates
• Review site visit reports, under the direction of the Associate Director or designee
• Other duties as assigned

Requirements:

• Bachelor's degree or equivalent is required (scientific or healthcare discipline preferred)
• Fully proficient in clinical trial coordination
• Understanding of study phases and general knowledge of how they apply to clinical development
• Working knowledge of ICH Good Clinical Practice guidelines
• Must be self-motivating and able to work on complex issues where analysis of situations or data requires an in depth evaluation of variable factors, including inter organizational impact
• Experience using computer applications including spreadsheets, email, word processing software and web based systems
• 10-30% travel may be required

Thank you!

Harish Yadav

Phone: 213-797-4030

harish.yadav@innovasolutions.com

PAY RANGE AND BENEFITS:

Pay Range*: ? $54.00-$58.00 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

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.

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