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.
Senior Clinical Research Associate - Oncology focused
Our Functional Service Provider (FSP) Team is currently seeking a remote based Oncology Experience Sr. Clinical Research Associate to support one of our top sponsors.
Minimum Qualifications
- 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.
- Previous and recent oncology experience, as an onsite traveling CRA, is required.
- In lieu of the above education requirement, candidates with a minimum of 6 years recent clinical monitoring experience will be considered.
- Thorough knowledge of regulatory requirements. Thorough understanding of the drug development process. Fluent in local office language and in English, both written and verbal.
- Three-Four (3-4) years of Clinical Monitoring experience
- Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
- Advanced site monitoring skills.
- Advanced study site management skills.
- Good computer skills with good working knowledge of a range of computer package.
- Advanced verbal and written communication skills.
- Ability to train and supervise junior staff.
- Ability to resolve project-related problems and prioritizes workload for self and team.
- Works efficiently and effectively in a matrix environment.
Responsibilities
- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.
- Responsible for all aspects of site management as prescribed in the project plans.
- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
- Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
- Monitor data for missing or implausible data. 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.
- Ensure audit readiness at the site level.
- Travel, including air travel, may be required and is an essential function of the job.
- Prepare accurate and timely trip reports.
- Manage small projects under the direction of a Project Manager/Director as assigned.
- Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans and trip report review as assigned.
- Review progress of projects and initiate appropriate actions to achieve target objectives.
- Organize and make presentations at Investigator Meetings.
- Participate in the development of protocols and Case Report Forms as assigned.
- Participate in writing clinical trial reports as assigned.
- Interact with internal work groups to evaluate needs, resources and timelines.
- Act as contact for clinical trial supplies and other suppliers (vendors) as assigned.
- Responsible for all aspects of registry management as prescribed in the project plans.
- Undertake feasibility work when requested.
- Conduct, report, and follow-up on Quality Control (QC) visits when requested.
- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned.
- Negotiate study budgets with potential investigators and assist the Fortrea legal department with statements of agreements as assigned.
- Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
- Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management.
- Assist with training, mentoring and development of new employees, e.g., co-monitoring.
- Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned.
- Perform other duties as needed or assigned.
Compensation and Benefits
Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:
- Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)
- 401(K)
- Paid time off - flex package
- Employee recognition awards
- Multiple ERG's (employee resource groups)
- Tuition Reimbursement
Target Pay Range: $120,000 to $135,000
Position fully remote
#LI - Remote
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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