Senior Clinical Research Associate Sponsor-dedicated
il y a 7 jours
Job Overview:
The Senior CRA I is responsible for site monitoring and site management. Responsibility for clinical studies according to Fortrea, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. The Senior CRA I assure the implementation of project plans, as assigned. Function as leader for projects of limited scope, as assigned. Assume line management responsibilities, as assigned. Act in the project role of a Local Project Coordinator or Lead CRA as assigned.
Summary of Responsibilities:
- The statements below are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties.
- Responsible for all aspects of study site monitoring including routine monitoring and closeout 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.
Qualifications (Minimum Required):
- University or college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.
- In lieu of the above education requirement, candidates with a minimum of 3 years relevant clinical research experience in pharmaceutical or CRO industries will be considered.
- Thorough knowledge of regulatory requirements including a basic understanding of regulatory requirements in other countries.
- Thorough understanding of the drug development process.
- Fluent in local office language and in English, both written and verbal.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience (Minimum Required):
- Three (3) years of Clinical Monitoring experience.
- Have a full understanding of Serious Adverse Event (SAE) reporting, process production on reports, narratives and follow up of SAEs.
- Advanced site monitoring skills.
- Advanced study site management skills.
- Advanced registry administration skills.
- Ability to work with minimal supervision.
- Good planning and organization skills.
- Good computer skills with good working knowledge of a range of computer packages.
- 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.
- Ability to work within a project team.
- Works efficiently and effectively in a matrix environment.
- Valid Driver's License.
Preferred Qualifications Include:
- One (1) or more year's additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
- Local project coordination and/or project management experience.
Physical Demands/Work Environment:
- Travel requirements: 60-80% overnight.
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.
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.
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