Clinical Research Associaterajeshlohakare
The in-house Clinical Research Associate serves as a key resource for the Clinical Research Department managing AVITA’s clinical trials.
- Contribute to monitoring plans and provide monitoring and study support resources to all studies.
- Review study protocols and study plans from an operational/monitoring perspective and provide meaningful and logical insights into its feasibility and appropriateness.
- Use study monitoring metrics to monitor recruitment, site visits, data quality, patient safety, timely submission of trip visit reports, timely escalation of any monitoring quality issues, etc.
- Contribute to development of patient recruitment strategies and identify barriers to recruitment and proposes solutions.
- Oversee and foster relationships with CRO study management and monitor counterparts during all stages of study (start up, conduct, closeout, and query resolution/data cleanup).
- Oversee monitoring and study support team for quality and compliance. Identify issues and escalate any areas of concern, including study conduct or personnel issues. Work with the CRO Clinical Lead/Lead CRA in managing communications and training for CRO CRAs.
- Ensure consistency in processes across all programs and strict adherence to WIs/SOPs, regulations and guidelines.
- Serve as the face of company at monitoring oversight visits. Cultivate site relationships through discussions with PI and site staff. Address all study related questions.
- Manage vendor activities for clinical studies ensuring that vendors are adhering to timelines, budget and are delivering quality.
- Maintain and/or accelerate timelines for achieving clinical research milestones.
- Perform other duties as requested.
- At least three years of experience working in clinical research
- 2+ years vendor/CRO management experience
- Commitment to excellence and high standards
- Flexibility and a proactive orientation
- Excellent organizational skills along with strong attention to detail
- Excellent verbal and written communication, strong organizational and interpersonal skills
- Knowledge and proficiency with Word, Excel, Power Point
- Ability to work independently and collaboratively in a dynamic, fast-paced, timeline-based environment
Bachelor’s Degree or equivalent clinical, healthcare or laboratory-related work experience is strongly preferred.
Ability to travel and support clinical research off-site meetings and events is required (approximately 10%).