Clinical Trial Lead (remote)
Health Decisions, Inc.
Health Decisions is a specialty CRO that utilizes a broad expertise across Women’s Health research with adaptive design and adaptive operational capabilities to deliver medicines and diagnostics of value to women worldwide. We are seeking a Clinical Trial Lead in our Durham Headquarters to lead the clinical monitoring team (Clinical Research Associates [CRAs] and In-house Clinical Research Assoicate [IHCRAs]), to ensure that projects are completed in accordance with the Task Order, client, and Health Decisions expectations.
- Provides oversight the feasibility and investigator selection, monitoring projections, including resource and visit projections, as well as, monitoring report review
- Manages study training for clinical monitoring team, overall site and CRA metrics
- site assignments and subject closeout
- Assist project management with resource and utilization assessments, timeline adherence, quality assurance, and financial adherence as it pertains to clinical monitoring team activities
- Act as secondary sponsor contact
- Is a resource and point of escalation for protocol and process questions from clinical monitoring team members
- Ensure site and in-house monitoring is occurring according to the monitoring plan and study timelines
- Create and modify study documents when needed
- Present at Investigator Meetings
- Review and approve expense reports
- Plan and facilitate site and CRA meetings
- Provide study status updates to the PM and escalate study issues
- Provide feedback on clinical team member performance to Line Managers.
We are looking for a BA/BS degree (preferably in a life science) with a minimum of 5 years of experience as a CRA or clinical trial lead. Progressive experience in the conduct of clinical research including ICH-GCP requirements, drug/device development process, and regulatory compliance is required; Strong leadership skills and demonstrated ability to manage others; Strong mentorship skills and advanced monitoring skills to ensure quality of monitoring for the clinical team is a must; Excellent written, oral communication, organization and presentation skills; Proficient computer skills, especially in Microsoft Office, and the ability to learn other applications.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.