2 Director of Quality - Atlas Clinical Research (Remote) Jobs in Rochester, NY
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Director of Quality - Atlas Clinical Research (Remote)
$168k-204k (estimate)
Full Time | Scientific Services
3 Weeks Ago
Rochester Clinical Research is Hiring a Remote Director of Quality - Atlas Clinical Research (Remote)
- Applicants must reside in one of the following states in order to be considered: NY, PA, NC, GA, AZ or FL****
Job SummaryUnder the direction of the Sr. VP of Portfolio Delivery, the Director of Quality is responsible for monitoring the quality and consistency of data and clinical operations across the Atlas network. This role will ensure that quality is built into all site and central processes and will partner with operations teams to verify quality outcomes. The Director will assist sites with preparing for and completing audits and inspections. This role will help the company succeed by reinforcing adherence to best-in-class processes, Good Clinical Practice, and federal and local regulations related to clinical research.
Key Responsibilities
- Create and maintain new Standard Operating Procedures (SOPs), Work Instructions, and other guidance at the network and site levels in compliance with ICH-GCP and federal, state, and local regulations as applicable.
- Create and oversee the annual Clinical Site Oversight Plan and actions.
- Review and edit existing SOPs, work instructions, and other guidance at the network and site levels for compliance with applicable regulations and conformity to network SOPs.
- Support the development and delivery of network and site-level training events, as requested, in various formats.
- In collaboration with site quality lead, conduct consistent internal risk-based study review activities to ensure compliance with ICH-GCP and applicable regulations.
- Work with the aligned operations team to remediate any issues or noncompliance identified at the site and implement preventive action as appropriate.
- Participate in other requested quality investigations and internal quality improvement initiatives, as assigned.
- Assist site and central operations teams to identify risks and mitigations; categorize, assess for trends and patterns, and identify the root cause of issues; implement, and track Corrective and Preventive Action plans (CAPAs).
- Routinely assess and report to operations on the risks impacting each site.
- Conduct and report on the quality reviews of external sites as part of the Mergers & Acquisitions (M&A) due diligence process.
- Participate in the integration of newly acquired sites into the network according to the integration playbook.
- Oversee audit and inspection readiness activities and share best practices to maintain a constant state of site inspection readiness.
- Attend site inspections and audits, as required; provide updates to internal leadership.
- Track and assist in the required training of site and central employees.
- Support the development and delivery of training materials for site employees (GCP, local and federal regulations, network SOPs, etc.)
- Help site directors assess employee performance to quality standards, particularly in the 90-day probationary period after hire.
- Participate in continuing education opportunities to stay up to date on relevant quality initiatives, regulatory guidance, and industry best practices.
- Bachelor's degree in sciences or related field. (Will consider Associate's degree with 5 years of equivalent experience).
- 3 years of experience in the clinical research industry required.
- 3 years of experience in a clinical quality role (GCP) required.
- Experience developing SOPs required.
- Excellent knowledge of current federal and local regulations on clinical research and GCP.
- Extreme attention to detail.
- Ability to communicate and work effectively with a diverse team of professionals.
- Strong communication and organizational skills.
- Comfortable taking direction from supervisor or working with autonomy.
- Proficient computer skills and use of MS Office.
- Ability to build rapport with employees and external clients.
- Ability to travel up to 20% of the time.
- $85-95K/year
Job Summary
JOB TYPE
Full Time
INDUSTRY
Scientific Services
SALARY
$168k-204k (estimate)
POST DATE
06/09/2024
EXPIRATION DATE
07/07/2024
WEBSITE
rcrclinical.com
HEADQUARTERS
ROCHESTER, NY
SIZE
<25
FOUNDED
1994
CEO
PATRICIA LARRABEE
REVENUE
$5M - $10M
INDUSTRY
Scientific Services
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About Rochester Clinical Research
Rochester Clinical Research is dedicated to advancing medicine and changing lives. Founded in 1994, RCR is a full-service clinical trials facility, providing phase I-IV out-patient research capabilities. "Your site worked as a cohesive team unlike any site I have ever been associated with. You met or exceeded every timeline without complaint. Your data was thorough and accurate; screen failures were minimal due to your excellent pre-screening. There is no one at your site who is not outstanding. I hope to work with your site on many future projects." -Monitor L.K., CCRA, CCRC , Pharmaceutical ...Sponsor www.rcrclinical.com
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