Jodiene Slocum, Regulatory Affairs Manager

• Provide oversight of the Regulatory Department for Infectious Disease practice focusing on HIV, STI and Covid-19 prevention and treatment trials phases I-IV.
• Maintains site files and corresponds with Sponsors, CRO's and IRB's.
• Experienced in Multi-Center, Single site, PI-IND and PI initiated trials.
• Process and Study start up documents and site IRB applications.
• Implement new department policies and maintain site SOP.
• Manage Data Entry team to ensure quality data and adherence to deadlines.
• Experienced in FDA, EMA and sponsor audits.
• Processed site Deviations and implemented new SOP's

AR for Clinical Research Department

• Generate invoices, track earned revenue, maintain site accounts.
• Produced monthly financial, management and operational reports for Medical Director and Administrator
• Performed final reconciliations and resolving any payment deficits.

• Primary Clinical Research Coordinator for >15 HIV, Hepatitis C and STI trials.
• Responsible for study related duties and phlebotomy according to Protocol.
• Consenting participants according to GCP and site SOP.
• Maintain communication with Sponsor / CRO.

• Assists in the coordination and completion of Regulatory processes.
• Performed site QA and internal quality checks are per SOP.
• Submitted any necessary documents to IRB's and IBC's.
• Performed regulatory study start up activities.

• Performed Data Entry into various EDC systems for >60 ongoing Clinical Trials.
• Performed quality Data Entry while following ECRF guidelines, protocol, and site SOP's.
• Prioritized Data Entry and developed QA site processes.