Accountable for the execution of the study start-up strategy and planning, including the management and coordination of start-up activities such as alignment to country regulations, Core/Site document collection/approval, ICF customization/approval, EC and RA/MoH submissions, SIV scheduling and activation requirements. Manage the study start up process, through development of a site activation strategy and to oversee start-up delivery and governance. Coordinate, develop and articulate the critical path planning, and implement as part of the Site Initiation Scheduling, System Set-up, EDL Management, EC & RA/MoH Strategy, ICF Customization, Risk Mitigations, Monitoring Plan, Site Activation Requirements & Relevant Tools. Collaborate and communicate within the Global study team matrix to provide study start up strategy, input to milestone development, and alignment of operational targets to ensure timely delivery of study start up activities. Participate in client meetings with respect to study start up, including endorsement of the SSU Operational Targets & mitigation of delivery risks, establishing client expectations for delivery, communication, reporting, and metrics. Partner closely with both Functional Leaders and Local Site Managers to proactively identify study start up related issues. Develop and execute corrective actions to mitigate risks to activation timelines. Ensure the relevant systems are maintained and up to date to analyse study start-up progress metrics against targets/timelines (at project/country/site level).

• Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase. • Build relationships with investigators and site staff. • Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include: Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments. Conduct remote Qualification Visits (QVs). • Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution. • Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation. • Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments. • Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval. • Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy. • Forecast, develop, manage, and revise plans and strategies for: IRB/IEC and MoH / RA submission/approval Site activation Patient recruitment & retention. • Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner. • Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc.

September 2020-June 2021 Performed project tracking to ensure clinical and site management information, including but not limited to project files, site contacts, client communications, and training assignments, are current, accurate, complete, and audit ready. Supported Project Manager (PM)/Regional Trial Manager (RTM) and Clinical Research Associate (CRA) in the management of investigational sites to ensure compliance with study timelines, the trial protocol, ICH/GCP and applicable regulations. Contributes to the development of solutions to complex issues, analyze current policies and procedures, and recommend changes as needed. Prepare, distribute, collect, evaluate, and approve regulatory documents required for regulatory compliance and IRB submission. Submits regulatory documents to Central IRBs and manage site submissions to Local IRBs; confirm IRB approval received and documented. Tracks milestones, generate study metrics, project specific metrics, and provide written and verbal updates to internal and external customers. Conducts regulatory packet submissions to clients for site approval and drug release. Supported the PM/RTM/CRA to resolve internal and external clinical issues for client research projects. Maintain, schedule, host, meeting minute taking and distribution of meeting minutes for team study calls and Investigator meetings. Manage CTMS site builds for study start up (IMPACT, RPI) Manage vendor spreadsheets (IRT, RAVE). Create slide deck and meeting content for Investigator meetings. Manage system access for study teams (IMPACT, CeDOC, RPI) Creates Trial Master Files (TMF) and maintains essential documents in compliance with FDA regulations, ICH/GCP, and local laws. (CeDoc) Tracks study activities, milestones, document receipt, and payment status in CTMS.

· Performs total site file reconciliation for studies ahead of schedule including reconcile against IRB approved documentation.· Performs protocol level reconciliation for studies ahead of schedule.· Trains and mentors fellow CTSs on proper eTMF naming and filing best practices to outperform timelines and ensure quality.· Contributes to the development of solutions to complex issues, analyze current policies and procedures, and recommend changes as needed.· Prepare, distribute, collect, evaluate, and approve regulatory documents required for regulatory compliance and IRB submission.· Submits regulatory documents to Central IRBs and manage site submissions to Local IRBs; confirm IRB approval received and documented.· Tracks milestones, generate study metrics, project specific metrics, and provide written and verbal updates to internal and external customers.· Conducts regulatory packet submissions to clients for site approval and drug release.· Creates and reviews project-planning documents including but not limited to Essential Document Review Plan (EDRP), Site Management Plan, and Project Plan.· Evaluates sites to determine interest, adequate subject population, facilities, staff and qualifications to conduct a study.· Facilitates execution of confidentiality agreement, contract and budget negotiation with sites.· Provides site training and access to required systems, including vendor systems, protocol compliance and regulatory requirements to ensure compliance.· Manages site relationships to ensure positive interactions through routine contact.· Ensures sites meet subject safety reporting regulations: subject safety information disseminated appropriately by evaluating consistency, quality and timeliness of serious adverse events reported by the site and submission to the IRB.· Creates Trial Master Files (TMF) and maintains essential documents in compliance with FDA regulations, ICH/GCP, and local laws.

· Recruited and evaluated potential sites for project participation and possible risks utilizing assessment tools and questionnaires to obtain project-required information.· Managed site activation and project requirements based on study contract.· Created activation timelines based on information obtained from Site Launch Meetings.· Acted as the lead In-House CRA.· Submitted site and study level IRB submissions.· Performed essential document collection, review, maintenance, submission, notification, and closeout activities ensuring client and investigator obligations are being met and comply with applicable local regulatory requirements, ICH/GCP guidelines, and PRA SOPs.· Performed project tracking to ensure clinical and site management information, including but not limited to project files, site contacts, client communications, and training assignments, are current, accurate, complete, and audit ready.· Trained and mentored more junior project support staff.· Liaised with internal and external customers, including vendors, to meet project specific goals including participation in sponsor and project related meetings.· Supported Clinical Team Manager (CTM)/Start Up Lead (SUL) and Clinical Research Associate (CRA) in the management of investigational sites to ensure compliance with study timelines, the trial protocol, ICH/GCP and applicable regulations.· Managed the quality review and negotiation of the informed consent.· Supported the CTM/SUL/CRA to resolve internal and external clinical issues for client research projects.

(same tasks as noted below in “Clinical Trials Assistant” and “Sr. Clinical Trails Assistant” role with these additional responsibilities)· Managed timelines and project requirements based on study contract.· Updated and maintained internal systems, databases, tracking tools, timelines and project plans with project specific information.· Coordinated with other project support staff within and outside the Clinical Project Management Unit to identify and consolidate support processes.· Assisted with project management activities as directed by project manager.· Managed and oversaw study start up activities for sites/study in the startup phase.· Managed billing worksheet, including rejecting and approval of billing activities.

· Set up, maintained, and provided technical support for clinical systems for assigned projects (e.g. InnTrax, InFORMant, Electronic Data Management (EDM), etc). within a specific therapeutic project unit, country, region, or client, as assigned.· Ensured the consistent use of designated clinical systems and/or procedures for assigned projects; conducted QC checks within a project, providing appropriate reports to PMs/CTLs to ensure better quality data.· Provided system/study support, and training for designated clinical systems to local and regional user(s) or project team(s).· Maintained interfaces for each project as needed and developed client interfaces on request.· Participated in user testing of new enhancements/functionality and/or review of associated procedures, training and documentation.· Identified and recorded quality problems; suggested, initiated, recommend or provided solutions as appropriate.· Understand financial and performance metrics requirements within region and/or project.· Entered new Investigators/Sites into the respective databases and keep this information updated as necessary by region.· Utilized system technical expertise to produce ad-hoc queries and metric reports providing information essential to business requirements.

(same tasks as noted below in “Clinical Trials Assistant” role with these additional responsibilities)· Provided leadership on multiple studies over junior level site staff.· Managed the quality review and negotiation of the informed consent.· Reviewed compensation agreement against CTAs to ensure accuracy.· Reviewed, negotiated and executed confidentiality agreement, contract and budget with sites.· Assisted in creation and maintenance of training manual for site staff use.

· Performed assigned administrative tasks to support team members with clinical trial execution, including accurately updating and maintaining clinical systems to track site compliance.· Supported the clinical team in the preparation, handling, distribution, filing, and archiving of clinical-documentation and reports according to the scope of work and standard operating procedures.· Coordinated and tracked all information, communications, documents, materials and supplies for assigned projects, including tracking and management of CRFs, queries, and clinical data flow.· Met with Sponsor to provide weekly site status updates and face-to-face twice annually for training and presentations.· Submitted site and study level IRB submissions.· Performed periodic review/audit of files for accuracy and completeness.· Managed preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.· Acted as a central contact for the clinical team for designated project communications, correspondence and associated documentation.· Trained and mentored more junior project support staff.

· Managed site file creation, maintenance, reconciliation, audits, and archival of Data Management Study files.· Performed administrative tasks including data entry, records management, scanning, and indexing to support team members.· Performed and ensured CRFs are processed, logged, and tracked in accordance with CRF Tracking and Data Entry Guidelines.· Developed and maintained good communication and working relationships by providing feedback to project team members.

· Provided customer service by analyzing billing, long distance patterns and services of AT&T products to recommend appropriate service to benefit customers and ensure satisfaction on multiple projects simultaneously.· Assisted in training classes of new employees.· Managed the operation, employee call in line and closing of call center with 500+ employees. (call to employee ratio coverage, end of day reports, employee leave, etc.)