Lisa Craddock Email & Phone Number

Durham, North Carolina, United States

Raleigh-Durham, North Carolina Area

• Single Point of Contact (SPOC) in assigned studies for investigative sites.
• Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines.
• Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
• Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Review, prepare and negotiate site contracts and budgets with sites.

• Mother and care provider for an in-home child care with five children between the ages of 6 weeks to 5 years old.
• Planning both long and short range activities in accordance with curriculum objectives, developmentally appropriate practice and program philosophy.
• Maintaining daily open and confidential communication with parents.
• Arranging and maintaining a safe and healthy classroom environment in accordance with program goals and philosophy.
• Meeting the emotional, social, physical and cognitive needs of each child, keeping all appropriate records such as accident reports, attendance and time sheets.
• Meeting all applicable licensing regulations, and completing assessments of each child's development as well as providing frequent updates to parents regarding the assessments including annual parent-teacher conferences.

• Conducted document collection, review and approval of investigator site regulatory package documents and Informed Consent Forms (ICFs).
• Customized Site Regulatory Packet (SRP) Guidelines.
• Prepared and submitted IRB/EC initial study documentation and safety updates.
• Performed ICF customization in accordance with ICH Guidelines, GCPs, local Regulatory Agency requirements.
• Prepared and submitted MoH/Regulatory Authority documentation and follow-up until final study approval was received.
• Performed contract language and budget negotiations.

• Assured adherence to GCPs, regulatory guidelines, and study procedures, as well as compliance with state and international regulations, SOPs and WIs.
• Communicated key study performance indicators to study team.
• Maintained regulatory documentation according to set guidelines and Trial Master File plans.
• Prepared for audits and provided responses/resolutions to audit findings.
• Prepared and disseminated regulatory information to sites and investigators.
• Provided assistance with in-house Case Report Forms (CRFs) review and completed data queries as needed.

Diploma, Medical Administrative Assistant Diploma

Education record