• Manage multiple clinical and lab services projects from initiation through contract completion.• Facilitate cross-functional interactions to complete the assigned projects within the deadline and compliance with pharma services plan.• Develop project plans, establish and coordinate timelines for assigned projects and functions.• Interface with resources outside of the company (Contract Research Organizations (CROs), site investigators, client counterparts, etc.) and serve as single point of contact with clients.• Track, maintain and communicate project reports and clinical study data.• Streamline cross-functional interactions to complete IVDR source documentation within the deadline and health authority's requirements.• Responsible for overseeing and managing the day-to-day operations of the clinical trials site. • Provide training and support to clients including research staff at clinical research sites, CROs, and pharmaceutical sponsors. • Serve as subject matter expert and point of contact for operational inquiries and troubleshooting.

• Provide trial support to multiple sites and participants• Assist clients with access and support to various databases essential for study• Provide assistance with trial essentials to CRA and sites• Provide clinical research support to the virtual investigator and their study staff• Review study protocols, associated study files, and electronic systems used, to conduct the virtual clinical research study• Support the virtual sites with documentation preparation, completion, tracking and maintenance• Perform periodic review of regulatory site records for completeness and accuracy• Support development of study tracking tools• Assist virtual research patients navigate virtual study platforms, address protocol questions such as timelines for visits• Collect, record, and assign research patent calls/queries/safety reporting to appropriate team members for follow-up• Participate in “huddles” with team members for the execution of the virtual project• Provide virtual trainings to new investigators and their site staff members on study-specific platforms and vendors used as part of the project• Support other job- related duties as assigned by the Clinical Lead or designee

• Collected, tracked, and submitted regulatory documentation as required by the FDA, and other regulatory bodies• Handled lab testing results provided by project vendors for the virtual studies and escalate out of range results as needed• Facilitated shipment of study supplies to virtual sites and/or study patients, including investigational products• Communicated with vendors regarding deliveries and collections requirements as documented in the protocol and agreements• Attended all relevant study meetings• Assisted with generating and collection of the virtual investigator site staff training and delegation of authority logs and other essential files• Ensured proper and current documentation is uploaded into the eTMF• Recruited participants as needed per protocol

• Complied with appropriate sponsor requirements and regulations which includes the FDA, GCP, institutional review boards.• Created and completed study related documents such as: Case Report Forms, source documents, reports• Coordinated study from study start up to study closure. • Maintained an ongoing report of study and recruitment status.

• Assisted with Internal Program Review (IPR) for the department• Worked with project manager to ensure projects met milestones and identified any potential timeline or project risks.• Worked with staff to complete quarterly progress reports.• Ensured project products were properly documented and accounted for• Assisted in managing multiple projects financial and overall statuses.

• Maintained compliance with protocols covering clinical trial operations.• Data Collection and followed research protocols, operations manuals and case report form requirements.• Work with principal investigator and sponsors to facilitate daily trial activities and ensure compliance with research protocols.• Responsible for assuring that the integrity and quality of the clinical research trial is maintained and that the trial is conducted in accordance with Good Clinical Practice guidelines and ICH guidelines.• Review approved regulatory documents from the IRB/IEC. • Attend in-house protocol meeting to review study-related procedures, staffing and visit flow. • Coordinate trial from phone screening through study completion.• Responsible for ensuring that subject qualifies for study prior to each dose. • Maintain and document communication with Sponsor or Sponsor representative(s) throughout the clinical trial. • Ensure randomization procedures are completed per study requirement. • Assure quality and completeness of source documents and Case Report Forms collected during the study. • Assist with monitoring visits on site and available during visits for correction, questions, etc

• Assisted the clinical research coordinator to ensure compliance with protocol.

• Followed informed consent processes and maintained records.• Reviewed subject medical histories• Performed vital signs, BMI and various other study specific procedures needed for study completion

• Transcribed source document data on to paper and electronic case report forms.