* Overall site management and leadership with a focus on driving site performance, enhancing efficiencies, patient safety and protocol/GCP/regulatory compliance.*Collaborating with department leaders in Business Development, Patient Recruitment, Finance, and Budgets Contracts and Quality to coordinate delivery expectations, meet expected study milestones, meet budgets, and delivery quality data to sponsors.*Reviewing the performance dashboards and other clinical trial systems to oversee site and patient activities, ensure proper staff coverage, and to ensure the data has been updated to reflect timely execution of all operational aspects.*Overseeing resourcing allocations, site assignments and study team members' output and performance, to ensure study deliverables are on track, identifying risks to delivery or quality, and escalating any risks to clinical trial management deliverables.*Assisting with initial and ongoing trainings regarding protocol specificities, Case Report Form (CRF) completion, Standard Operating Procedures (SOPs), clinical plans and guidelines, and timelines for the study.*Ensuring adherence to standard operating procedures, good clinical practice (GCP), FDA regulations, and company policies and procedures.*Overseeing site staff assigned to the study and routinely assessing study-specific process and training compliance,CMP compliance and identifies emerging risks. May develop and support execution of corrective action plans at site and study level.*Overseeing people management activities.*Overseeing team timecards, new hire orientation, and training.*Collaborating with investigators*Employing strategic thinking and problem-solving skills to propose and implement risk mitigations.*Participating and presenting in management or site meetings.

Conducts and follow study protocol, company processes & procedures, and in compliance with FDA, GCP, ICH regulations and guidelines: Screening of patients for study enrollment;Patient consents; Patient follow-up visits; Documenting in source clinic charts; Entering data in EDC and answers queries; Obtaining vital signs and ECGs; May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up; Requesting and tracking medical record requests;Updating and maintaining logs, chart filings; Maintaining & ordering study specific supplies; Scheduling subjects for study visits and conducts appointment reminders;Building/updating source as needed; Conducting monitoring visits and resolves issues as needed; Ensuring study related reports and patient results are reviewed by investigator in a timely manner.Filing SAE/Deviation reports to Sponsor and IRB as needed. Report and follow up with AE.Maintaining positive and effective communication with clients and team membersAlways practicing ALCOAC principles with all documentation.Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc.Prepare and attend site initiation visits (SIV’s)Handles all IRB functions for assigned studies independently, and/or with assigned regulatory team member, as needed.Assist with scheduling and planning for visit capacity for assigned studiesSet up, train and maintain all technology needed for studiesMay assist with study recruitment, patient enrollment, and tracking as neededMay handle more complex study assignments and volumesTrained and mentor Clinical Research Assistant and other coordinatorsMaintaining confidentiality of patients, customers and company information, and performing all other duties as requested or assigned.

The RA performs clinical, lab, and administrative tasks as needed for the successful operation of the clinical research site. • Assists with the basic screening of patients for study enrollment• Assists with patient follow-up visits• Documents in source clinic charts• Enters data in EDC and answers queries• Obtains vital signs and ECGs• Perform basic lab procedures per protocol, such as: blood specimen collection, centrifugeoperation, storing and shipping of lab specimens, accountability of specimens and notificationof courier for specimen pick-up• Request and track medical record requests• Assists the CRC with updating and maintaining logs and filing in charts• Schedules subjects for study visits, conducts appointment reminders, and reschedules visits ifneeded• Ensures study related reports and patient results are reviewed by the Research Coordinator and/orinvestigator in a timely manner.• Assists the CRC and/or Manager with study recruitment, patient enrollment, and tracking as needed• Maintains strict confidentiality of patients, employees, customers and company information at all timesand adheres to HIPAA Guidelines• Perform all other duties needed, requested or assigned

TransCelerate Approved GCP Certificate • ICH GCP E6 R(2)• FDA Regulations 21CFR 11, 50, 54,56 and the Common Rule 45CFR46• Data Management• Informed Consent Process• Clinical Trial Operations from feasibility through close-out.• GDP following ALCOA-C principles• Identification and reporting of AEs and SAEs• Quality Assurance, Monitoring and Query Resolution• Comprehension and Execution of Clinical Trial Protocols• Maintaining regulatory binder, housing essential documents including but not limited to 1572, DOA, Training Logs and other Investigator Site File (ISF) documents

· Manage and direct the work of 60+ employees. Ensure we maintain the schedule and payroll budget of the store. Assign work, delegate and empower my team to ensure goals meet deadlines.· Human Resources management of 60+ employees– ensure trainings are being completed, policies and procedures are being followed and handle personal records and associate relations to ensure and maintain a collaborative environment. Monitor compliance with labor, employment and safety regulations.· I prepare and conduct evaluations to review and calibrate the team to maintain company business acumen. I mitigate risks and recommend operational improvements to achieve developmental growth within the company. Review and analyze reports and audits to develop and improve action plans and maintain accountability of products in the building.• Presidents Club Award - a top performer award in the company