Lead / Senior Associate, Clinical Ops (Study Start-Up/IRB) – Direct Hire/Top $$ - RTP, NC
Our client, a Research Triangle Park area contract research organization that offers real world data solutions to support clinical research and other healthcare research initiatives, is actively recruiting for a skilled and knowledgeable candidate to join its Clinical Operations team.
This company, an innovator in its approach to healthcare research, conducts disease-focused observational research studies using real world data gathered from clinical sites and other providers.
This Senior Associate / Lead (client is open on level) will oversee the daily operations of the Clinical Sites and ensuring compliance with regulatory and company guidelines. This is a key role and company will pay excellent wage to attract and retain a high-quality candidate.
Key Things to Note:
- This is a Direct Hire role that can be worked remotely for now. Post-pandemic, this position will be on-site at the company’s RTP offices, with flexibility to work-from-home on occasion.
- This Senior Associate / Lead will work with the clinical sites, to ensure that all study start-up and operational requirements are met. Familiarity with 21 CFR 50 as well as requirements for TMF and Informed Consent documents will be important.
- Position will also involve ensuring compliance with IRB submission standards. Familiarity with 21 CFR 56 is required.
- The selected candidate will oversee the work of 3 Clinical Ops Specialists, who interact with the sites on day-to-day operations. We seek those who have experience leading small teams.
- This company is growing rapidly. The demand for Real World Evidence and Observational Study solutions is increasing steadily. Company policies and practices are changing daily to meet the needs of the future. We seek a builder who will contribute to new and enhanced strategies.
- Act as Subject Matter Expert (SME) on Clinical Operations requirements and provide regulatory, compliance and operational leadership to internal teams.
- Provide oversight and training of the Clinical Operations Shared Services Team.
- Develop Quality Assurance and Clinical Operations Standard Operating Procedures (SOPs), Working Practice Documents (WPDs) and associated tools. Update as needed.
- Ensure Quality Framework, ICH/GCP and applicable Code of Federal Regulations compliance.
- Ensure Trial Master Files are complete, accurate and audit/inspection ready by creating, implementing and managing the quality control activities for all clinical studies.
- Participate in Informed Consent template development.
- Oversee and participate in Informed Consent negotiation with clinical sites.
- Provide feedback to IRB queries.
- Review essential documents in accordance with applicable Code of Federal Regulations, HIPAA, ICH/GCP Guidelines and company requirements.
- Participate in decision-making to create processes to improve operational efficiencies.
Targeted candidate will offer a related degree and 3+ years handling similar role in a Clinical Operations setting. 1+ years of team lead work will be important. CCRP or CCRA is a plus.
Other priorities include:
- Substantial experience with study start-up/essential documents
- Experience working with IRB submissions and related requirements
- Knowledge of Trial Master File requirements and Best Practices
- Expert knowledge of 21 CFR 50, 21 CFR 56, ICH/GCP Guidelines and HIPAA
- Exceptional organizational skills, including the ability to juggle multiple simultaneous demands
- Keen attention to detail and compliance orientation
- Record of impact and growth
Finally and critically, we seek a candidate who will thrive in this empowered and dynamic setting; a team player who can work through ambiguous and evolving issues to get to smart and effective solutions.
This company is doing important work. We seek a go-getter who is ready and able to contribute.
Please forward Word resume for prompt consideration. Local candidates targeted.