Clinical Research Associate II (CRA II)

at  Fortrea

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. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Are you passionate about clinical research and eager to contribute to innovative healthcare solutions? We’re looking for enthusiastic, dedicated individuals to join our team as Clinical Research Associates (CRAs). If you’re ready to make a difference and grow your career in a dynamic environment, read on!

What You’ll Do:

• Be a Monitoring Maestro: Take charge of all aspects of study site monitoring, including routine visits, close-outs, and file maintenance. You’ll also conduct pre-study and initiation visits, ensuring everything runs smoothly.
• Manage with Mastery: Oversee site management activities as outlined in our project plans, ensuring every detail is handled with precision.
• On-Site Excellence: Ensure study staff are well-prepared, informed, and ready to safely include patients in our studies.
• Protect Participants: Uphold the highest standards of patient protection by ensuring informed consent procedures and protocol adherence.
• Data Integrity Champion: Verify and review data meticulously to maintain the integrity of our research.
• Efficiency Expert: Optimize resources and travel expenses while performing monitoring tasks in line with our SOPs and guidelines.
• Audit-Ready: Keep sites prepared for audits at all times.
• Travel Enthusiast: Travel as needed to monitor sites and prepare thorough trip reports.
• Registry Management: Handle all aspects of registry management as per project plans.
• Feasibility Guru: Conduct feasibility studies and support quality control visits when requested.
• Investigator Recruitment: Assist in recruiting potential investigators, prepare EC submissions, and manage regulatory notifications and study documentation translations.
• Client Interaction: Work in client-facing environments, ensuring smooth communication and cooperation.
• Adverse Event Tracker: Track and follow up on Serious Adverse Event (SAE) reporting and documentation.
• Data Review: Perform independent CRF reviews, query generation, and resolution.
• Mentor and Train: Assist in training new employees and coordinate clinical projects.
• And More: Take on various other tasks as assigned by management.

What You Bring:

• Experience: At least 2 years of clinical monitoring experience or equivalent education/experience combination.
• Independence: Ability to monitor study sites independently according to guidelines and regulations.
• SAE Knowledge: Thorough understanding of SAE reporting and follow-up procedures.
• Organizational Skills: Strong planning, organizational, and problem-solving abilities.
• Communication: Excellent communication and interpersonal skills.
• Analytical Mind: Sharp analytical and negotiation skills.
• Tech Savvy: Competent with computers and data management systems.
• Bilingual: Fluent in the local office language and English, both written and verbal.
• Team Player: Ability to work efficiently in a matrix environment.

Education:

• Degree: A university or college degree, or certification in a related allied health profession (e.g., nursing licensure) from an accredited institution.
• Knowledge: In-depth knowledge of ICH Guidelines, local regulatory requirements, and monitoring procedures.
• Clinical Insight: Basic understanding of the clinical trial process.
• Driver’s License: A valid driver’s license is required.

Why Join Us?

• Innovative Environment: Be part of cutting-edge clinical research that shapes the future of healthcare.
• Career Growth: Opportunities for professional development and career advancement.
• Collaborative Culture: Work with a dynamic team that values collaboration and innovation.
• Impactful Work: Make a real difference in patients’ lives through your contributions to clinical trials.

If you’re ready to embark on an exciting career journey and make a meaningful impact in clinical research, apply today!
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.
For more information about how we collect and store your personal data, please see our
Privacy Statement

• Be a Monitoring Maestro: Take charge of all aspects of study site monitoring, including routine visits, close-outs, and file maintenance. You’ll also conduct pre-study and initiation visits, ensuring everything runs smoothly.
• Manage with Mastery: Oversee site management activities as outlined in our project plans, ensuring every detail is handled with precision.
• On-Site Excellence: Ensure study staff are well-prepared, informed, and ready to safely include patients in our studies.
• Protect Participants: Uphold the highest standards of patient protection by ensuring informed consent procedures and protocol adherence.
• Data Integrity Champion: Verify and review data meticulously to maintain the integrity of our research.
• Efficiency Expert: Optimize resources and travel expenses while performing monitoring tasks in line with our SOPs and guidelines.
• Audit-Ready: Keep sites prepared for audits at all times.
• Travel Enthusiast: Travel as needed to monitor sites and prepare thorough trip reports.
• Registry Management: Handle all aspects of registry management as per project plans.
• Feasibility Guru: Conduct feasibility studies and support quality control visits when requested.
• Investigator Recruitment: Assist in recruiting potential investigators, prepare EC submissions, and manage regulatory notifications and study documentation translations.
• Client Interaction: Work in client-facing environments, ensuring smooth communication and cooperation.
• Adverse Event Tracker: Track and follow up on Serious Adverse Event (SAE) reporting and documentation.
• Data Review: Perform independent CRF reviews, query generation, and resolution.
• Mentor and Train: Assist in training new employees and coordinate clinical projects.
• And More: Take on various other tasks as assigned by management