Clinical Operations, Associate
Innova Solutions
- Nutley, NJ
- $26.00-28.78 per hour
- Contract
- Full-time
Duration : 12+ Months
Location: Remote OpportunityAs a Clinical Operations Associate, your responsibilities::Description:
- The Clinical Operations Associate will perform activities related to the distribution of Safety Alert Reports and Plain Language Summaries globally.
- The Associate must possess strong computer skills for database management and troubleshooting.
- The ideal candidate has problem solving and critical thinking skills, meticulous attention to detail, proofreading/QC, and time management skills, which are essential for success in this role.
- This multi-person, time sensitive, process requires a candidate that is reliable, dependable, and dedicated to ensure deadlines are met.
- Assist with the processing of all ICSR and Aggregate documents including, but not limited to: SUSARs, IND Safety Alerts, Six Monthly Line Listings, DSURs etc. 50%
- Assist with the maintenance of the safety alert reporting system including, but not limited to: data maintenance, troubleshooting, and validation testing. 10%
- Develop and apply an understanding of country specific, Regulatory reporting requirements for 50+ countries worldwide 5%
- Identify issues with the distribution/receipt of safety alert reports in order to provide support to the study teams for all inspection readiness activities. 15%
- Interact/collaborate with interdisciplinary groups such as Safety, Study Teams, CROs, and IT in order to resolve distribution issues and resolve incoming inquiries. 5%
- Assist with inspection readiness activities including but not limited to running reports, reconciling reports received and distributed, and gathering information for storyboard development 10%
- Assist with obtaining and tracking key milestone dates including but not limited to Clinical Trial specific SIV, COV, Country Approval, LPLV, and Country Close Out 5%
- Bachelor's Degree required
- 1-3 years of Pharmaceutical experience
- Must be able to analyze issues in order to discover the root cause
- Strong computer skills, particularly experience with database management, data entry, and troubleshooting
- Strong follow through skills are necessary to ensure submissions reach their final destination in a timely manner
- Knowledge of safety report submission activities is a plus
- Strong desire to learn and the ability to quickly grasp multiple skills simultaneously
- Regulatory experience is a plus
- Strong proofreading, editing, and reviewing skills are required
- Must be detail oriented, highly organized, and quality driven
- Possess a strong work ethic and be able to work both as part of a team and independently
- Prior experience dealing with sensitive, or confidential, documentation
- Experience contributing to guidance documents (SOPs/SWPs/User Manuals, Job Aides etc.)
- Strong written, and verbal, communication skills
Ramesh Tummala - Lead Recruitment
ramesh.tummala@innovasolutions.com
(+1) 678-648-7395PAY RANGE AND BENEFITS:
Pay Range*: Between $26.00 to $28.78 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 MSWebsite: 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.