Job Summary:
The Sr. Clinical Research Associate (CRA) supports moderately complex clinical trial activities in support of the Clinical Trial Manager(s). The CRA works closely with the clinical trial team to ensure site related start-up through close-out activities are conducted according to Good Clinical Practice (GCP) and relevant SOP's. The CRA may assist with vendor oversight and management. They will identify issues in a timely manner and escalate to management as appropriate. The CRA may complete monitoring visit report review and perform co-monitoring. The core duties and responsibilities of the CRA are delineated below.
Duties/Responsibilities:
- Organizes, and supports trial managers, in conduct of all study team via agenda and meeting minute preparation, completion and distribution.
- Manages Site Essential Documents review during study start-up, maintenance and close-out period
- Prepare study documents (i.e. consent forms, site instructions, study specific materials such as the Manual of Operations, Pharmacy binder, etc.)
- Ensures tracking and filing of essential documents in the appropriate tracking systems.
- Ensures tracking of patient status throughout the study at investigative sites
- Responsible for maintaining internal tracking systems of patient and site status in support of trial and management needs.
- May review and approve trip reports, track data query reports, site visit metrics, and overall site performance
- May perform routine monitoring at limited clinical sites
- May perform site initiation, routine monitoring and close-out visits at a limited # of clinical sites, as well as co-monitoring with local CRAs
- Ensures quality of the data generated from clinical sites and assists in resolving subject eligibility and protocol deviation issues
- May assist in the preparation of, and may present at investigator vendor meetings and workshops
- Actively involved in the performance of study feasibility assessments
- Provides rapid action to address both internal and site QA findings from audits
- Coordinate the activities from third party vendors including metrics, accruals, process planning, and implementation
- Routinely participates in department and clinical trial team meetings and participates in collaborative efforts (e.g. protocol development, CRO selection, departmental initiatives, etc.)
Requirements:
- Bachelors degree or higher
- 3 or more years industry experience from Pharmaceutical, Biotechnology or Contract Research Organization (CRO), to include at least 1 years of site or hospital experience
- Previous site monitoring experience preferred
- Working knowledge in Good Clinical Practices (GCP) regulations and Standard Operating Procedures
- Understanding of study phases and general knowledge of how they apply to clinical development
- Advanced knowledge of Word, Excel, and PowerPoint.
- Knowledge of the principles and practices of computer applications in database management
- Strong verbal and written communication skills required.
- 20% - 30% travel may be required
In addition to a great culture, we offer:
• An entrepreneurial, highly collaborative, and innovative environment
• Comprehensive benefits, including:
- Medical, Dental, and Vision
- Group Life Insurance
- Long Term Disability (LTD)
- 401(k) Retirement Plan
- Employee Assistance Program (EAP)
- Flexible Spending Account (FSA)
- Paid Time Off (PTO)
- Company paid holidays, including the year-end holiday week
- Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.
If all this speaks to you, come join us on our journey!
Base Salary: $110,000 - $135,000. Exact compensation may vary based on level, skills and experience.
