Today, the biggest bottleneck in bringing new treatments to patients is the clinical trial. On average, getting a drug through the trial process takes nearly a decade & frequently costs $100M+. And the problem is only getting worse.
At TrialSpark, we dont believe it has to be this way. Through technology & a new operational model, were reimagining how clinical trials are run, with the mission of bringing new treatments to patients faster.
We do this by partnering with physicians to enable them to run clinical trials within their existing practices. By providing the technology platform, equipment, & staffing, TrialSpark alleviates the operational burden of clinical research, enabling physicians to focus on what they do best -- patient care. And by bringing clinical research to physician practices, TrialSpark is enabling access for the 98% of patients who are never exposed to clinical trial opportunities.
The contract Clinical Research Associate (CRA) is responsible for monitoring clinical trials across clinical sites. Monitoring of clinical trials is accomplished by ensuring compliance with the clinical protocol, the Clinical Monitoring Plan, ICH GCP, & TrialSparks Clinical Operations SOPs. The CRA performs Pre-Study Qualification visits, Site Initiation visits, Interim Monitoring visits, Remote Monitoring visits, Close Out visits, centralized data review, & site management. The CRA is expected to operate in accordance with Good Clinical Practice (GCP) guidelines & applicable federal & state regulations, including those stipulated by the U.S. Food & Drug Administration (FDA) & the Health Insurance Portability & Accountability Act (HIPAA).
Duties & Responsibilities
Duties include, but are not limited to:
- Attend CRA calls & internal team calls
- Complete study specific training & submit documentation for each training
- Schedule & track monitoring visits in TrialSpark system in accordance to the Clinical Monitoring Plan
- Schedule monitoring visit travel (airfare, hotel, transportation) according to TrialSpark guidelines
- Maintain TrialSpark systems with critical site information, ie, site status, contacts, training, milestone dates, patient status
- Serve as sites primary point of contact
- Conduct site training virtually & in person
- Review & collect essential documents & ensure they are filed in the electronic Investigator Site File
- Meet quality standards for trial monitoring activities, with respect to documentation, punctuality of reporting & escalations, & co-operation with other project team members.
- Generate & resolve queries
- Source data review & source data verification
- Investigational Product Accountability
- May participate in the study development & start-up process reviewing CRFs, developing study documents, working with management on monitoring strategy, and/or developing study-specific site training
- Quality, & on-time trip report completion
- Timely site correspondence for visit confirmation & follow-up letters
- Identify, document, & track site action items
- Participate in feasibility and/or site identification activities
- Mentor in-house CRAs
- Participate in the development of study communication as required
- Assist with the development of project-specific forms & templates
- Submit expense reports in timely manner (within 14 calendar days of the visit end date)
Required Education & Experience
- B.A./B.S. with strong emphasis in science and/or biology preferred
- A minimum of five years of clinical research monitoring experience as a CRA for industry-sponsored clinical trials.
- Travel is required for the position
- Ability to communicate in English (both written & verbal)
- Ability to present technical & scientific information.
- Good understanding & working knowledge of clinical research, phases of clinical trials, current GCP/ICH.
- Hands on knowledge of Good Documentation Practices.
- Developed monitoring skills & independent professional judgment.
- Good IT skills (use of some clinical IT applications on computer, tablet & mobile devices) & ability to adapt to new IT applications on various devices.
- Wifi set-up in home office
You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.