• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines• Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites• Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely• Provides regular site status information to team members, trial management, and updates trial management tools• Completes monitoring activity documents as required by PRA SOPs or other contractual obligations• Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues• Escalates site and trial related issues per PRA SOPs, until identified issues are resolved or closed• Performs essential document site file reconciliation• Performs source document verification and query resolution• Assesses IP accountability, dispensation, and compliance at the investigative sites• Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH GCP guidelines• Communicates with investigative sites• Updates applicable tracking systems• Ensures all required training is completed and documented• Serves as observation visit leader• Facilitates audits and audit resolution

• Perform feasibility studies for potential sites as requested.• Conduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements.• Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB / IEC study approval, informed consent, etc.)• Coordinate study material (e.g. CRFs, manuals) shipment and receipt by study site• Document site visit findings via written reports.• Provide input into the design of protocols, CRFs and monitoring plans as requested• Assess, monitor, and train study site staff on protocol adherence as required.• Review study subject safety information and informed consent.• Conduct source document verification for compliance, patient safety, and veracity of data.• Review CRFs using paper or electronic data capture systems.• Assist the site in maintenance of the Investigator Site File.• Maintain regular communication with sites.• Provide applicable updates for site related documentation for filing in the Trial Master File (TMF)• Assist sites in data query resolution.• Ensure site compliance with IP receipt, accountability and return or destruction.• Conduct accompanied site visits for assessment or training of other CRAs as requested and appropriate.• Complete final site close out visit and report.

Perform either on-site or remote site visits and monitoring activities in accordance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements, and complete appropriate documentation (confirmation, follow-up letters, trip reports and /or communication logs) as required.• Evaluate overall performance of site and site staff.• Interpret data to identify protocol deviations or major risks to data integrity.• Act as a liaison between the company and study site personnel and be able to respond to site concerns and questions.• Review and verify case report forms and other clinical data for completeness and accuracy. • Monitor patient safety and identify and address any protocol deviations.• Participate in the identification and selection of investigators and clinical sites.• Obtain, review and process regulatory and administrative documents from investigator sites.• Ability to travel as necessary may be up to 70% depending on assignments. Overnight and occasional weekend travel may be required.

Conduct monitoring visits for assigned protocols and study sites. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.• Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. • Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas. • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Clinical Research Specialist (CRS) and/or line manager. • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. • May provide assistance to less experienced clinical staff. Therapeutic areas include: Respiratory, Immunology, Neurology, Urology

• Assist Clinical Research Specialist (CRS)/In-house Clinical Research Specialist (iCRS), Clinical Research Associates (CRAs)/In-house Clinical Research Associate (iCRA) and Regulatory and Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines. • Collaborate with Clinical Project Manager (CPM), CRS/iCRS, CRAs/iCRAs and RSU on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files and completeness. • Collaborate with CRS/iCRS, CRAs/iCRAs and RSU on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information. • Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow. • Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation. • Assist in training and orienting new staff. May act as a mentor for less experienced CTAs. • Accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required approval.

• Creation, maintenance, and archive of Trial Master Files in accordance with PAREXEL Standard Operating Procedure (SOP), GCP, and FDA regulations. • Maintain PAREXEL’s electronic document management system, and ensure quality and content of paper and electronic central files. • Conduct quality control checks of central files in accordance with PAREXEL SOPs and operational best practices relating to document management. • Coordinate close out activities of central files and provide support to Clinical team for termination visits to ensure proper documentation.• Communicate with investigative sites and vendors to resolve discrepancies and ensure timely completion of clinical studies. • Name, upload, and perform scan image checks of electronic documents. • Track, scan, code, file, and retrieve documents as requested for project team members. • Support project team for internal and external audits.• Provide administration support, including the set-up of meetings, record meeting minutes, preparing memos, faxing, copying and scanning.

• Administrator of Clinical Document Control Room. Reviewed and processed clinical documents for submission to central files. Managed document tracking and ensured document compliance with GCPs.• Provided administration support, including the set-up of meetings, taking minutes, preparing memos, faxing, copying and scanning. • Communicated with sites, clinical vendors, and others within the company to resolve discrepancies and ensure the timely completion of clinical studies. • Inventoried, prepared and supervised the shipment of clinical trial supplies.• International Trial experience.• Knowledgeable in SOPs, GCP and ICH regulations

• Designed, performed, and analyzed experiments for the purpose of enablement, screening, or testing of new products and cell lines. Experience with both R&D and HTS formats.• Designed and conducted parental cell growth, maintenance and expansion projects.• Extensive cell culture experience in both small and large scale formats.• Performed and scheduled maintenance duties on laboratory equipment and have experience working with standard lab automation.• Advised on the testing and purchase of laboratory reagents. Coordinated with vendors for the availability and production of supplies. Implemented testing and produced reliable results.• Prepared and performed Q.C. of the DNA used by the other group members.• Created and executed SOP’s for cell culture techniques.• Accurately maintained records and laboratory notebooks