Innova Solutions is immediately hiring a Clinical Research Associate

Position type: Full-Time, Contract

Duration: 6 Months

Location: Remote

As a Clinical Research Associate, you will

• Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or solicited from a clinical trial including safety database entry, AE review, write patient narratives with coding, follow-up of missing information, listedness assessment against appropriate label (For Marketed products, if applicable).
• Submission of expedited Serious Adverse Event (SAE) reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Client project personnel, if required & as agreed with client during study set-up, within study specified timelines.
• Prepares timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs), Annual IND reports, European Annual Safety Reports (ASRs), Development Safety Update Report (DSUR), Periodic Reports (PRs) line listings, and aggregate reports.
• Perform peer/independent QC of Safety reports as needed.
• Work with Data Management or client on reconciliation of safety databases, if appropriate.
• Maintain a strong understanding of Client safety database conventions or client-specific database conventions, as appropriate.
• Maintains a comprehensive understanding of Client PSS Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
• Assist in signal detection, trend, and pattern recognition activities, as appropriate.
• Monitor workflow for assigned studies/programs to ensure all the timelines are met.
• Assist in the development of departmental Work Instructions (WI) and Standard Operating Procedures (SOPs), as appropriate.
• Participate in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics/data provided.
• Support/train less experienced safety staff in all aspects of case-handling, adverse event reporting and other work, as needed.
• Responsible for making decisions regarding adverse event reporting within the guidelines of each specific project.
• Actively participates in project team and client meetings and liaise with clients, where appropriate.
• Assist with proactive quality issue resolution and implementation of actions, as needed.

Education and Experience:

• Associate degree of less will need 2-3 years of experience.
• BS or higher will need 2 years of less.
• Need at least 1 year of QC experience.

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.

Thank you!

Charan Chiraboina

Team Lead - Recruitment

charan.chiraboina@innovasolutions.com

P:(+1)314-523-1805

PAY RANGE AND BENEFITS:

Pay Range*: $45.00/hr to $47.00/hr

*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 field

Recent Recognitions:

· One of the 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.comor (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.

Job Type: Contract

Salary: $45.00 - $47.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• Associate (Preferred)

Experience:

• Quality Control: 1 year (Required)
• Serious Adverse Event (SAE) reports: 1 year (Required)
• Individual Case Summary Reports (ICSRs): 1 year (Required)
• pharmacovigilance reports: 1 year (Required)
• safety databases: 1 year (Required)

Work Location: Remote

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