CRA II - Sponsor Dedicated

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 ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

We are recruiting for our sponsor-dedicated (FSP) business in Türkiye and are seeking to hire a CRA II on a permanent, full-time contract.

Our positions offer excellent exposure to a range of disease areas, and a real opportunity for career progression and promotion in time.

At Fortrea, you will have autonomy to organize your work and in return, you will be supported and empowered to go beyond the typical CRA role, to really be an expert on your protocols and to own your sites.

Summary of Responsibilities:

• Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.

• Prepares and implements project plans related to Clinical Monitoring responsibilities.

• Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.

• Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.

• Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.

• Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements.

• Ensures adherence to global quality control and CRA performance metrics.

• Ensures audit readiness at site level.

• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study. Ensure the protection of study subjects or patients by performing eligibility review, verifying that screening, informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.

• Ensure the integrity of the source data reported by careful source document review. Monitor data for missing or implausible data.

• Ensure study data completeness, accuracy, consistency, and compliance; identify deficiencies, deviations and discrepancies, and initiate corrective action as required.

• Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.

• Prepare and submit accurate and timely trip reports.

• Independently perform eCRF review, 100% source data verification, query generation and resolution against established data review guideline with or without direct supervision, on Fortrea or client data management systems, as assigned by management.

• Assist with the administration of clinical research projects, recruiting investigators (if applicable), collecting investigator documentation and site management.

• Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems.

• Track IP shipments and supplies, as needed.

• Track and follow-up on serious adverse events as assigned.

• Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met.

• Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned.

• Attend investigators’ meetings (if applicable), project team meetings and teleconferences, and others as needed.

• Present training content for site initiation.

• All other duties as needed or assigned.

Qualifications (Minimum Required):

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.

• Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.

• Thorough knowledge of monitoring procedures.

• Good understanding of the clinical trial process.

• Fluent in local office language and in English, both written and verbal.

Experience (Minimum Required):

• A minimum of 1 year of Clinical On-Site Monitoring experience.

• Monitoring experience in interventional studies.

• Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines.

• Have an understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.

• Good planning, organization, and problem-solving abilities.

• Works efficiently and effectively in a matrix environment.

• Good understanding of medical and clinical research terminology and clinical research processes.

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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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If you require a reasonable accommodation to complete your job application, pre-employment testing, job interview or to otherwise participate in the hiring process, please contact: taaccommodationsrequest@fortrea.com. Please note that this e-mail address is only for job seekers requesting an accommodation.  Please do not use this e-mail to check the status of your application.