Biotrial, a leading provider of high-quality pharmacology services , is currently recruiting a Clinical Research Associate for its U.S. headquarters in Newark, New Jersey. With over 30 years of experience in providing scientific and medical services in Early Clinical Development, Biotrial possesses one of the largest clinical capacities in Europe. The company’s 60,000 sq. ft., 110-bed, state-of-the art Clinical Pharmacology Unit is in the heart of University Heights Science Park, attached to Rutgers/NJMS and the University Hospital.
The Clinical Research Associate participates in the preparation and execution of Phase I-IV clinical trials. This position will be responsible for monitoring clinical trials in accordance with Good Clinical Practices and procedures set forth by Biotrial and sponsors, and will oversee the progress of clinical investigations.
Under the supervision of Clinical Operations, duties and responsibilities relative to the Clinical Research Associate will include, but will not be limited to:
- Organize and perform monitoring and logistics of clinical trials (Phase I to IV).
- Participate in the selection of investigative centers and in contract negotiation, including costs.
- Assist project managers in the coordination of clinical trials and with regulatory filing submissions.
- Participate in writing important documents related to clinical trials, including source documents and other trial documentation and follow-up reports.
- Ensure that the trials run smoothly in the different investigative centers; that study protocols are respected and Good Clinical Practice procedures (ICH-GCP), and procedures of Biotrial and Sponsors are followed.
- Work in close collaboration with the different project team members (Project Manager, Data Manager, Biostatistician and Pharmacovigilance Manager) to ensure all monitoring activities are conducted according to study requirements.
- Requires a Bachelor's degree (Masters a plus) in life sciences or related field.
- Minimum 3-5 years of experience in Phase 1 clinical research and knowledge of GCP and FDA regulatory requirements are required.
- Good understanding of the drug development process.
- Must have previous experience in monitoring clinical studies.
- Excellent written and verbal communication skills, as well as interpersonal skills.
- Exceptional time management and conflict resolution skills required.
- Ability to interact with all levels of management, sponsor and study site personnel.
- Detail-oriented and possess good trouble-shooting skills with the ability to prioritize and execute tasks in a high-pressure environment.
- Proficient computer skills in Microsoft Office Suite.
Biotrial is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, genetics, disability, age, veteran status, or any other characteristic protected by law.
Job Type: Full-time
- 401(k) Matching
- Dental Insurance
- Disability Insurance
- Employee Assistance Program
- Health Insurance
- Life Insurance
- Paid Time Off
- Vision Insurance
- Clinical Research: 3 years (Required)
- monitoring clinical trials: 2 years (Required)
- Clinical Research Associate: 2 years (Required)