As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
The eCOA UAT Tester serves as a member of the project team with primary responsibility for all documentation requirements in support of Global EDC, eCOA, and IRT Solutions tasks to include creating, reviewing and executing of validation documentation. Assist project teams with validation tasks as requested, i.e., with the creation, production, printing and tracking of study documentation and controlled documents.
Summary of Responsibilities:
• Supports validation activities as assigned and serves as a validation team member.
• Writes and assembles validation documentation packages such as but not limited to, validation plan, test scripts, testing results, traceability matrix, validation reports.
• Support virtual global validation team as needed to complete validation projects.
• Maintains and utilizes knowledge of SOPs and validation procedures/standards in relation to system development cycle.
• Executes test cases against requirement, enters errors in error tracking logs and performs retest documenting resolutions.
• Assist project teams with validation tasks as requested.
• Execute validation test scripts as requested.
• Ensure quality of work.
• Prioritize workload to meet specified completion dates ¨ Assist with the maintenance of validation metrics.
• Supports in maintaining testing documentation and files.
• Carry out all activities according to Fortrea Standard Operation Procedures (SOPs) and project specific conventions within the framework of Quality Management and Good Clinical Practice (GCP)/ICH guidelines.
• Maintain accurate records of all work performed.
• Perform other duties as assigned by management.
• Assist with special projects as designated.
• All other duties as needed or assigned.
Qualifications (Minimum Required):
• University / college degree (life sciences, health sciences, information technology or related subjects) or a certification in allied health professions from an appropriate accredited institution.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Fluent in English, both written and verbal.
Experience (Minimum Required):
• 3 -5 years of relevant work experience to include Validation support and execution.
• Good problem-solving skills and a proactive approach.
• Good oral and written communication skills.
• Good time management skills and maintain the highest standards of quality work. ¨ A neat, methodical and thorough approach to the work with an emphasis on attention to detail.
• Good concentration skills are required to meet the consistently high standards expected.
• Self-motivation with the ability to work under pressure to meet demanding deadlines.
• Ability to work under minimal supervision.
• Ability to prioritize work.
• Effective communication skills and the ability to work as part of a team.
• Flexibility – being able to move from one computer system to another with ease and adapt to new technology and a constantly changing work environment.
Preferred Qualifications Include:
• University / college degree (life sciences, health sciences, information technology or related subjects) or a certification in allied health professions from an appropriate accredited institution.
• 3 -5 years of relevant work experience to include Validation support and execution.
• Good problem-solving skills and a proactive approach.
• Good oral and written communication skills.
• Good time management skills and maintain the highest standards of quality work. ¨ A neat, methodical and thorough approach to the work with an emphasis on attention to detail.
• Good concentration skills are required to meet the consistently high standards expected.
• Self-motivation with the ability to work under pressure to meet demanding deadlines.
• Ability to work under minimal supervision. T
• Ability to prioritize work.
• Effective communication skills and the ability to work as part of a team.
• Flexibility – being able to move from one computer system to another with ease and adapt to new technology and a constantly changing work environment.
Pay Range: $18.00-$25.00 per hour (The range does not include benefits, and if applicable, bonus, commission, or equity)
Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), and Company bonus where applicable. For more detailed information, please click here.
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Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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