Stephanie Garner Email & Phone Number

• Lead recruitment efforts for various indications to align with project goals by conducting pre-screening, screening, enrollment and randomized study visits both remotely and in person• Create and maintain pre-screening questionnaires by collaborations with cross-functional departments to ensure quality subject enrollment and meet/exceed contract goals• Ensure compliance with trial protocol, GCP/ICH guidelines, HIPAA, other applicable guidelines• Facilitate data collection, source completion, EDC and data entry, specimen collection and processing, and query resolution with a high level of accuracy• Review and extract data from EMR (eClinical) and various databases to utilize in subject recruitment and reporting while maintain integrity of data and patient privacy to decrease screen failure rates•ISF maintenance • vital signs, EKG, chart review and documentation, medication administration

Remote

• Direct manager to Travel Clinical Research Coordinators for decentralized trial team providing remote oversight of daily operations ensuring site staff compliance and training with protocol, GCP/ICH guidelines, and state and local regulations• Analyze and assign site staff based on project goals and facilitate establishment of decentralized clinical research sites • Develop and maintain paper and electronic source documents, Quality Assurance and Standard Operating Procedures• Coordinate internal, external and FDA audit preparation• Develop and implement safety processes, maintain regulatory documents and CTMS• vital signs, EKG, chart review and documentation, medication administration

• Lead Travel Clinical Research Coordinator for Decentralized Trial department• Provide oversight of site set up and break down, implementation of protocols, and site management • Ensure compliance to protocol, SOPs, GCP, and maintaining integrity of data and patient/staff safety• Facilitate informed consent, data collection, data entry for EDC and/or CRF completion, query resolution, and coordination with interdepartmental teams• vital signs, EKG, chart review and documentation, medication administration

• Lead Clinical Research Coordinator for CNS trials with at least 10 studies running concurrently• Provided oversight of implementation of protocols, data collection, query resolution and sponsor communication•Develop and implement Quality Assurance processes, Standard Operating Procedures and maintain CTMS• Led provider relations, business development, recruitment, audit preparation, and contract negotiation efforts• Provide staff coaching, training and development • Ensure completion of required training, proper documentation, and compliance to protocol, SOPs, GCP and regulatory guidelines throughout all cycles of trial projects• Data collection, data entry and query resolution, and source creation• Coordinating departments for study involvement• vital signs, EKG, chart review and documentation, medication administration

Raleigh, North Carolina

• Direct and hiring manager to all 25+ research staff.• Establish infrastructures to support site, assessed risks, assured milestones were met• Data collection, data entry and data integrity/verification, and data management• Manage contract and budget negotiations, modifications, and drafting• Lead business development and provider recruitment effortsLead patient recruitment efforts, review EMR for internal patient eligibility• vital signs, EKG, chart review and documentation, medication administration

• Direct and hiring manager for team of 5 research technicians• Oversee and coordinate all aspects of study related activities at site for hematologic malignancy/oncology trials ensuring protocol and regulation adherence• Coordinate specimen collection for physician-initiated studies• Assist in development and implantation of plan to merge specimen repositories and improve ICF documentation and specimen collection processes• Data collection, data entry, query resolution, regulatory document maintenance, update EMR (EPIC)• vital signs, EKG, chart review and documentation, medication administration

Raleigh-Durham, North Carolina Area

• Manage at least 7 general medicine Phase I-IV study projects concurrently• Conduct and coordinate protocol trainings and interdepartmental meetings• Data collection, data entry, query resolution, specimen collection and processing• Facilitate Informed Consent and conduct study visits ensuring adherence to protocol, GCP and regulatory guidelines• Assist in managing overnight and weekend project schedule• vital signs, EKG, chart review and documentation, medication administration

Bachelor Of Science - Bs, Computer And Information Systems Security/Information Assurance

MUMA College of Business: Information Assurance and Cybersecurity Management. Citizen Data Science Certificate

Associate’S Degree, Business Administration

Certified Medical Assistant