Clinical Studies Manager, Medical Device (Irvine, CA)

SNAPSHOT!

Looking for a chance to join a world-class ophthalmic medical device company in Orange County experiencing explosive growth? In this fast-track, permanent role, you’ll be Under the direction of the Sr. Manager and Clinical Operations. The Clinical Study Manager is accountable for the day to day operational activities related to planning, executing and reporting of assigned clinical study. The Clinical Study Manager supports the clinical department by carrying out assigned tasks and projects leading to the achievement of department goals and objectives. Our client offers an excellent comprehensive benefits package that includes health insurance, paid holidays, paid vacation and sick leave, and a 401(k) plan!

Immediate Opening for a Clinical Studies Manager in Irvine, CA who possesses:

• Minimum Bachelor's degree or two years equivalent experience required in biological science, nursing, or other related discipline.
• Strong team orientation and experience working in a team environment. 

KEY RESPONSIBILITIES INCLUDE:

Clinical Research Monitoring

• Travel to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits.

• Verify informed consent procedures are properly followed.

• Evaluate investigator compliance with the study protocol and applicable regulations.

• Verify sites are collecting all required source data per protocol.

• Assist with clinical monitoring tasks including review of clinical report forms (CRFs) and electronic data.

• Review the regulatory binder and essential documents at the site and verify all documents are appropriately filed.

• Verify essential documents are both filed in the site's regulatory binder and the study master file as required.

• Capture, document, and communicate Adverse Event information in accordance with the study protocol and regulatory requirements. 

Clinical Site Management

• Maintain frequent contact with investigators and site staff to monitor progress, answer questions, and provide guidance during the course of the clinical study.

• Assist site with development of essential study documents and IRB submissions/approvals. Verify all essential documents are properly executed and prepared prior to shipment of investigational product.

• Prepare and verify proper execution of all required investigator agreements, including Non-Disclosure Agreement, Investigator Agreement, and Compensation Agreement.

• Prepare faxes, newsletters, and other forms of communication to assist with enrollment and study compliance at clinical sites. 

Clinical Study Execution

• Be familiar with study timelines and budget and communicate potential issues to management.

• Monitor and track study implementation and progress, including provision of information to management for grant payments to the sites.

• Track, post on the shared drive, and file essential documents in the study master file.

• Assist in preparation and planning for investigator meetings.

• May be responsible for or assist with management of outside vendors, including Contract Research Organizations, Data Management vendor, reading centers, CRF printers, etc.

• May assist with the development of study protocols, investigator brochures, site-specific instruction manuals, case report form designs, patient information documents, monitoring plans, informed consents, site training documents, and source document templates.
• May assist in managing the DCC process for clinical documents.

• May participate in preparation of regulatory submissions necessary to initiate and maintain clinical studies and marketing approvals, including clinical study reports, safety reports, and annual reports.

If you’d like to explore, send your resume to admin@snapstaffing.com and we’ll follow up with you ASAP!