Position Summary:
The Clinical Research Associate is responsible for tracking and maintaining study specific non-CRF databases and administrating clinical research projects. This is accomplished by collecting documentation, site management, clinical contact, and reviewing CRF’s. The CRA is also responsible for maintaining relationships with investigators. The ideal candidate must be willing to traveling to various worksites.
Key Responsibilities:
- Maintain a strong relationship with each Investigator and clinical site staff.
- Initiate, monitor, and close-out investigative sites in accordance with FDA/ICH regulations.
- Track and maintain study specific non-Case Report Form database
- Administer Clinical research projects; collect investigator documentation, site management, clinical contact, and prepare monthly status reports.
- Review Case Report Forms to identify erroneous, missing, or incomplete data.
- Generate data queries to resolve problematic data to appropriate personnel, and review responses to assure the database is updated accordingly.
- Report, write narratives, and follow-up on reported serious adverse events.
- Verify study drug accountability; generate and track drug shipments and storage.
- Travel as necessary, based on project needs.
- Participate in the development of protocols and Case Report Forms.
- Perform data collection, retrieval, entry and clean up as necessary.
- Negotiate study budgets with potential investigators.
- Independently manage sites confirming clinical study site operations are completed under site procedures
- Perform other duties as assigned by management.
Qualifications:
- BS/BA in appropriate field (e.g. Life Sciences, Pharmacy, or Nursing) or applicable education with relevant experience.
- Experienced with numerous EDC system
- Experience in the pharmaceutical industry or hospital setting is preferable.
- Ability to work and travel independently with minimal supervision.
- Self-motivated attitude.
- Computer competency (Microsoft Word and Excel)
- Good communication skills. Good command of written English.
- Meticulous attention to details.
About Us:
Cognitive Research Corporation (‘CRC’) is a privately held, full-service contract research organization that specializes in Central Nervous System (CNS) product development for pharmaceutical, nutraceutical, biotechnology, and medical device companies. With offices in Florida and an integrated network of experienced research facilities, CRC is well-positioned to conduct clinical studies at any stage, Phase I-IV. To find out more, visit us at https://cogres.com/
If you're ready to make a meaningful impact in the field of clinical research, apply now to our Contract Coordinator opening. Enjoy a dynamic work environment, opportunities for growth, and the chance to contribute to life-changing medical advancements.
Job Type: Full-time
Pay: $67,800.00 - $106,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
Education:
Experience:
Ability to Relocate:
- New York, NY: Relocate before starting work (Required)
Willingness to travel:
Work Location: Multiple locations
