Tara Johns

Oversee remote patient data monitoring activities for Phase I-IV clinical research and/or non-interventional studies (NIS) to assess compliance with protocol, ICH-GCP, patient safety, and/or all applicable local and federal regulatory requirements. Management of multiple trials, between 3 and 5 at all times with up to 6 central monitors on each.

• Author and understand Clinical Monitoring Plan (CMP), Project Management Plan (PMP), Project Communication Plan (PCP), understands Protocol, Therapeutic Indication and Monitoring Strategy specific to assigned studies
• Perform subject and site-level remote monitoring activities as per CMP when needed, and oversees central monitoring reviews and monitoring reports, along with on-site IMV reports when needed.
• Conduct remote/on-camera Pre-Site Selection Visit (PSSVs), remote Site Initiation Visit (SIV), and site training, and draft corresponding reports for approval.
• Perform SDV of patient data
• Ability to synthesize data trends, issues, and action items in clear and concise presentation of most relevant and actionable items for interpretation by CRAs, Clinical Trial Managers, Project Managers, and other functional roles assigned follow-up
• Ensure patient safety and data integrity though review of patient data listings, systems, and visualizations via analytical dashboards, EDC data and/or reports
• Emphasize data review for informed consent, subject eligibility, AEs/SAEs/SADEs/DDs and associated documentation, safety reporting, critical data issues and trends, significant errors or data integrity risks and trends, site process issues, subject level deviations/site level non-compliances, action items, data queries, and IP dosing and reconciliation
• Document observations noted during reviews and issues queries, creates action items, and records protocol deviations in appropriate systems for action by sites, CRAs, or other functional team members
• Review query responses and associated actions entered in EDC by site personnel to confirm appropriate response/closure
• Assess site data quality, risks and trends as well as operational performance and summarize findings for CRA review and action planning
• Follow escalation pathways as per CMP if finding noted during Monitoring activities is considered to have significant impact on subject safety, data integrity or regulatory compliance, and serves as liaison between sponsor and central monitoring group
• Central Monitoring Report review and any additional tasks as assigned
• Develop robust and comprehensive training materials to improve monitoring staff competencies and performance.
• Provides Central Monitoring/RBM leadership and technical support to Clinical Operations team to ensure quality of deliverables and achievement of financial goals; oversight of Central Monitoring activities and assigned Central Monitors; study plan authoring and reviews, and creates study-specific tools as needed; point of escalation for central monitoring and clinical questions
• Serve as Risk Based Monitoring Subject Matter Expert for project teams with superior understanding of Monitoring processes, activities, and technologies.

• Perform remote patient data review activities for Phase I-IV clinical research and/or non-interventional studies (NIS) to assess compliance with protocol, ICH-GCP, and/or all applicable local and federal regulatory requirements
• Conduct remote PSVs, SIVs, and draft corresponding reports
• Complete Remote Data Review, Key Risk Indicator Review, and Site Central Assessment Notification Reports
• Synthesize data trends, issues, and action items in clear and concise presentation of most relevant and actionable items for interpretation by CRAs and other functional roles assigned follow-up at site level
• Ensure patient safety and data integrity though review of patient data listings, systems, and visualizations via analytical dashboards and/or reports
• Document observations noted during reviews and issues queries, creates action items, and records protocol deviations in appropriate systems for action by sites, CRAs or other functional team members
• Assess site data quality, risks and trends as well as operational performance and summarize findings for CRA review and action planning
• Primary contact for project site personnel, work in collaboration with on-site CRA
• Responsible for site management including performance of remote site qualification, remote site initiation, remote site monitoring calls (SMCs), and remote close-out visits ensuring regulatory, ICH-GCP and protocol compliance, and completes required actions as requested by Clinical Leads and /or Lead CMA
• Responsible for ensuring correct IP receipt, handling and storage; knowledge of protocol, study procedures and adherence to study CMP; supporting subject/patient recruitment and retention strategies; collection, ongoing review, and maintenance of study documents to ensure accuracy, timeliness and completeness of TMF; remotely reviews electronic data and assist sites in resolving queries and/or other identified data issues
• Document monitoring activities via confirmation letters, follow-up letters, and reports within established timelines
• Monitor site performance metrics and, with guidance, implements action plans for sites not meeting expectations
• Assume role of Lead CMA where needed for project inclusive of but not limited to: performing study-level KRI Review, Phone PSSV, Phone SIV, SMC, and Phone COV report reviews; oversight of CMA performance and Central Monitoring activities; work in collaboration with Clinical Lead and ensure successful project completion
• Support Central Monitoring Lead with report review and any additional tasks as assigned
• Provide training and mentoring of Central Monitors

• Primary contact for project site personnel, in collaboration with on-site CRA
• Responsible for site management including performance of remote site qualification, remote site initiation, remote interim site monitoring calls (SMCs), and remote close-out visits ensuring regulatory, ICH-GCP and protocol compliance, and completes required actions as requested by clinical leads
• Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements
• Responsible for ensuring correct IP receipt, handling and storage; knowledge of protocol, study procedures and adherence to study Clinical Monitoring Plan; supporting subject/patient recruitment and retention strategies; collection, ongoing review, and maintenance of study documents to ensure accuracy, timeliness and completeness of Trial Master file (TMF); remotely reviews electronic data and assist sites in resolving queries and/or other identified data issues
• Documents monitoring activities via confirmation letters, follow-up letters, and SMC reports within established timelines
• Performs site-level Remote Accumulated Data Review (RADaR) utilizing appropriate tools to identify, respond to and manage issues in line with associated guidelines
• Monitors site performance metrics and with guidance implements action plans for sites not meeting expectations
• Performs all tasks routinely and independently while providing support for team members as needed
• Remote visits trainer and assessor for less experienced CMAs

• Primary contact for project site personnel, in collaboration with on-site CRA
• Responsible for site management including performance of remote site qualification, remote site initiation, remote interim site monitoring calls (SMCs), and remote close-out visits ensuring regulatory, ICH-GCP and protocol compliance, and completes required actions as requested by clinical leads
• Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements
• Responsible for ensuring correct IP receipt, handling and storage; knowledge of protocol, study procedures and adherence to study Clinical Monitoring Plan; supporting subject/patient recruitment and retention strategies; collection, ongoing review, and maintenance of study documents to ensure accuracy, timeliness and completeness of Trial Master file (TMF); remotely reviews electronic data and assist sites in resolving queries and/or other identified data issues
• Documents monitoring activities via confirmation letters, follow-up letters, and SMC reports within established timelines
• Monitors site performance metrics and with guidance implements action plans for sites not meeting expectations
• Performs all tasks routinely and independently; implements majority of action plans for sites not meeting expectations seeking guidance as needed
• Continuous knowledge development of SOPs, WIs and ICH-GCP requirements; implementing these within all projects
• May act as remote visit trainer for less experienced CMAs.

• Contributed to preparation of training materials (Investigator Meeting, Site Evaluation ad Initiation Training, etc.)
• Managed process for planning and procuring ancillary clinical supplies
• Facilitated and collated country recruitment plans
• Crated and managed study specific tools such as recruitment and retention materials and study newsletters
• Maintained study level storyboard
• Facilitated authoring of Investigation Product Information Manual (IPIM) and study specific Important Protocol Deviation Listings
• Compiled IRB/EC submission documentation
• Assisted with Global Development Operations operation review preparation
• Prepared Clinical Study Team meeting agendas and minutes
• Managed global versioning and distribution of informed consent forms (ICFs)
• Facilitated cross functional meetings
• Submitted document to trial master file (TMF) for study level documents.

• Performed feasibility studies/site identification activities for potential sites
• Coordinated study material shipment and receipt by study site
• Ensured completeness and compiled regulatory documents and ethical submission documents
• Provided applicable updates for site related documentation for filing in Trial Master File (TMF)
• Assured maintenance of Investigator Site File in TMF
• Reviewed site visit findings and assisted with resolution of identified issues
• Maintained regular communication with sites
• Completed remote CRF review, using electronic data capture systems
• Assisted sites in query resolution
• Assisted with ensuring site compliance with IP receipt, accountability and return or destruction, as applicable and appropriate
• Provided mentoring and training for In-house CRA 1 and CRA 1
• Assisted LCRA with reports and trackers.

• Provided support or assistance to clinical teams as directed
• Participated in implementation of key organizational process improvement initiatives
• Contributed to standardization and dissemination of best practices for clinical study conduct
• Established and maintained relationships with study sites and team members to ensure professional, timely, and ongoing communication and documentation for each project
• Organized, initiated, and attended project related meetings
• Compiled and prepared project related materials for internal meetings, including agendas and minutes, to ensure information was complete and accurate and facilitated project meetings
• Oversaw and maintained databases to ensure up-to-date information was continually available for review and reporting
• Tracked, reviewed and prepared study-specific information utilizing databases, spreadsheets, and other tools
• Headed coordination of negotiations of Clinical Trial Agreements and budgets with legal, external legal consultants, vendors and study sites
• Reviewed and approved Clinical Trial Agreement language modifications as applicable
• Reviewed and approved budget modifications and reconciled study invoices for payment approval: inclusive of investigator grant payments
• Processed all investigator grant payments, confirm receipt, and maintained payment histories
• Obtained, tracked and reviewed regulatory documents from sites prior to IRB/IEC submissions and internal regulatory submissions for final approval of drug shipment
• Headed coordination of central and local study level and site level IRB submissions
• Maintained study files according to SOPs
• Processed drug shipments and assisted with drug returns and destruction on site and remotely
• Maintained clinical supply inventory and distribution
• Communicated with sites to track upcoming patient visits, resolution of queries, and status of ethics submissions
• Assisted with the development of documents for site study binders and provided templates as needed
• Served as an internal team back up providing verbal and written communication with study personnel
• Reviewed and participated in the quality assurance of documents.

• Researched local requirements for documentation of IRB/EC submission approvals, and subsequent follow-up documentation and assisted with IRB/EC submissions
• Liaised with study sites regarding essential documents collection and review and, as required by country, site contract/budget negotiations
• Arranged/reviewed translations of regulatory documents as required
• Customized country/site specific Patient Information Sheets and Informed Consent Forms
• Provided regular local status updates and updated appropriate study-tracking tools
• Assisted with conduction of feasibility of studies as required
• Ensured that all documents were completed and submitted to Trial Master File properly
• Maintained 100% compliance with all internal and sponsor SOPs
• Mentored and trained new team members on study-specific tasks
• Worked closely with on-site monitors to maintain the integrity of documentation at research sites.

• Performed essential document collection, review, and maintenance, ensured that sponsor and investigator obligations were being met and were in compliance with applicable local regulatory requirements and ICH/GCP guidelines
• Supported investigators and staff in fulfilling obligations with regard to submission according to local regulatory and IRB/EC requirements
• Reviewed highly scientific informed consent forms using IRB approved study specific templates for merging and comparing and approved proper changes for submission
• Ensured proper filing and storage of regulatory documents and training documentation into TMF
• Reviewed and submitted protocols, amendments, and all other required materials to IRB
• Performed study tracking via Oracle CTMS or sponsor designated system to ensure that study files were current, accurate and complete
• Performed investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools for use in evaluating investigative sites for feasibility
• Utilized CTMS for accurate and efficient investigator recruitment
• Documented site and client contact and study interactions in a timely manner
• Assisted with resolution of investigational site/data queries
• Worked with project team members regarding study site issues
• Worked actively in project team environment by participating in internal and external client meetings
• Assisted team members with completion of clinical research project-specific tasks
• Supported mentors and business unit contacts in fulfilling obligations such as preparing and maintaining documentation, plans, reports, schedules, databases, spreadsheets, and logs, as was needed
• Mentored and trained new team members on study-specific tasks