| Job Title | Clinical Research Associate |
| Department | Clinical Operations |
| Role type | Operational |
| Level | Associate |
| Location | Columbus, Ohio – Sollis Headquarters |
| Travel Requirement | 60-80% |
| Reporting | Senior Director of Clinical Operations |
Background and position justification:
Sollis Therapeutics is a clinical stage specialty pharmaceutical company developing innovative non-opioid pain therapies to treat important pain conditions. Sollis’ model is to in-license compounds in mid to late stage and complete development work required for approval.
As such, clinical trials are a key part of the strategy of Sollis and critical to our success. Sollis intends to execute clinical trials in partnership with Contract Research Organizations and other service providers. Sollis believes working relationships with such entities is a core competency that can determine success or failure of clinical trial activities and indeed, the company.
The role, Clinical Research Associate (CRA), is intended to provide day-to-day support for clinical trial activities, at the direction of the Senior Director of Clinical Operations. The CRA will interface with contract service providers and with clinical sites to ensure that the needs of these stakeholders are continuously met.
Summary of Position:
- This position is critical to the successful execution of clinical trials and involved in all Clinical Operational activities and Clinical Research alliances
- The position also ensures a close working relationship with NIT and other NIT companies, as appropriate
- The position works with the Senior Director of Clinical Operations and other stakeholders to ensure proper functioning of clinical trial activities
Job Duties/Responsibilities:
Providing support for outsourced activities:
Is thoroughly familiar with clinical research and the activities of the department. Understands Good Clinical Practices, clinical trial performance, compliance, processes, and procedures.
Supports the Senior Director of Clinical Operations ensuring that Sollis’ needs with respect to clinical trials performance are met
Vendor relationships:
Is familiar with standards and processes related to engaging vendors to support clinical activities.
Supports the Senior Director of Clinical Operations ensuring that all vendor engagements are well designed, effective, compliant
- Gathers information as needed
- Prepares Requests for Proposal (RFP) under the direction of the Senior Director.
- Supports in scheduling of meetings and calls
Supports the Senior Director of Clinical Operations ensuring the performance of clinical trials activities
- Authors processes and procedures
- Performs site, vendor, and other stakeholder training
- Provides day to day support for clinical sites, trial partners, and other stakeholders
- Escalates to the Senior Director any observation that may result in compromise in trial performance
Interactions with other functions:
Maintains an excellent working relationship with all internal Sollis staff/functions
Other responsibilities:
This role will also provide support to other Sollis projects and needs, as appropriate.
Education, Experience, Skills, and Knowledge:
Minimum:
Undergraduate degree, preferably in life sciences
Desired:
Advanced degree such as Ph.D. in life science
Experience, Skills, Knowledge
- 3 + years experience in clinical operations in the pharmaceutical industry
- Thorough understanding of clinical operations, including working knowledge of contemporary clinical trial software
- Familiar with Good Clinical Practices and trial compliance
- Demonstrated ability to follow directions and work autonomously in executing on directives
- Prior experience in working with outside organizations/groups
- Demonstrated ability to think critically, identify and solve problems
- Excellent communication and time management skills
- Continuous quality improvement mindset and attention to details
- Proven ability to interact well in a multifunctional team setting
- Can do attitude, flexibility, and mental agility