Evolution Research Group

• Assume primary accountability for assigned clinical research projects and ensures compliance with applicable regulations, guidelines, and corporate policies for study activities. • Manage and execute the overall project scope, budget, and timelines. • Identify project success factors for analysis, reporting, and tracking. • Manage resources and timelines associated with all study start-up and implementation activities. • Lead the development of study specific protocols, consent forms, and other trial related materials as required. • Ensure the appropriate development of study documents including, but not limited to, study plans, case report form instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies. • Participate in the review of clinical data for analysis. • Ensure that all project tasks meet client expectations and are completed in accordance with the contract, trial protocol, and Standard Operating Procedures (SOPs). • Serve as a liaison between clients and internal team to ensure project specific information and ongoing updates are proactively communicated. • Plan for and manage all materials to support the appropriate execution of the clinical projects, including but not limited to distribution of documents, forms, supplies, equipment, and investigational devices. • Monitor adherence to project contract and budget. • Coordinate with clinical, business development, and operations management to identify goals and scope of clinical study projects. • Ensure operational and regulatory integrity of assigned studies and participate in FDA or other regulatory authority inspections, as needed. • Support the management and oversight of clinical study related vendors. • Review site monitoring reports ensuring finalization as required by SOP and/or client contractual requirements. • Enhance department and organization reputation by participating in departmental or corporate initiatives. • Update job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations. • Attend off-site meetings and conferences, as needed.

• Support Clinical Operations to ensure studies are completed, on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines. • Archive and organize clinical trial master file documents, including clinical study site documents, generate filing indexes and maintain currents lists of correspondence. • Assist in preparation of documents including regulatory document templates, study binders, study communications and presentations. • Manage clinical, regulatory, and study-related essential documents such as study protocols, Informed Consent Forms, etc. • Assist with all aspects of initial study drug release including regulatory packet review and study-drug release. • Assist in the preparation and development of study-specific training materials. • Participate in the planning of investigator meetings. • Interact with sites as needed to respond to issues. • Handle incoming and outgoing shipments, as needed. • Monitor and track monitoring visit reports. • Collect enrollment updates and reports on a weekly basis. • Assist PM with set up and preparation of project meetings.

• Primary responsibilities include medical and safety oversight of clinical trials • Provides services to clinical trials with the aim to monitor the safety and wellbeing of study participants • Ensure integrity of the project data in accordance with clinical trial protocols, SOPs, GCP, and regulatory requirements • Perform in-depth medical assessment of key study information through review of the protocol, Investigator Brochure, Informed Consent Form, and appropriate literature • Provide medical input for protocol design, as appropriate • Participate in Site Initiation Visits and/or Investigator Meetings • Provide 24/7 medical consultancy support to investigators and study team • Prepare and/or review the Medical Monitoring Plan, as well as the Safety Management Plan and related study documents • Support the clinical team for subject selection regarding interpretation and application of the protocol inclusion and exclusion criteria • Follow study status via email, phone calls, and participation in team meetings • Participate in safety review meetings per protocol • Perform review of Serious Adverse Events (SAE) reported by sites to assess medical contents and case completeness • Collaborate with site staff, Lotus team members and sponsor staff to finalize each event • Develop and/or SAE narratives and MedWatch reports • Review protocol deviations and classify according to agreed criteria • Provide support for the clinical team regarding early discontinuation of treatment and end of study assessments • Provide review of adverse events, concomitant medications and medical history to assess overall risks to subject safety • Provide Medical review of other study data such as laboratory results, ECGs, etc. per the scope of work • Provide review and comment on the Clinical Study Report regarding overall study conduct and safety data

• Conduct site monitoring responsibilities for Clinical trials, according to Standard Operating Procedures, ICH guidelines, and GCP. • Manage and monitor site activities for assigned clinical studies, working individually or co-monitoring with other Clinical Research Associates (CRAs). • Monitoring activities will include but not be limited to site qualification, site initiation, interim monitoring, and close-out visits. • Ensure compliance with the protocol and applicable Company or Sponsor Standard Operating Procedures (SOPs), FDA regulations, and ICH-GCP guidelines. • Perform site evaluation visits of potential investigators. • Evaluate the capability of the site to successfully manage and conduct the clinical study. • Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the case report forms, monitoring activities and study close-out activities. • Assist in resolving any issues to ensure compliance with site file audits. • Direct communication with investigational sites on visit planning, query resolution, action item resolution, and any other activities to support site management. • Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. • Perform investigational product inventory. Ensure return of unused materials to designated location or verify destruction as required. • Serve as primary contact with the site; coordinate all correspondence; ensure timely transmission of clinical data with the study site. • Perform study close-out visits per the study specific Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items. • Ensure internal and study-related trainings are completed per Lotus and/or study timelines. • Pre and post visit follow up include compliance to timelines indicated in the Monitoring Plan (MP) for Confirmation Letters, Follow up Letters and Monitoring Visit Reports (MVR).