Katie Tillman

Reporting to the Associate Director, Global Site Relationship Management, managing 30+ investigator sites, building strong relationships, supporting enrolment and recruitment activities and acting as liaison for investigators sites and CRO from feasibility through close-out over three company portfolios.

• Build and maintain relationships with new and existing clients while providing high level of expertise.
• Obtain relevant knowledge about the assigned region - treatment standards, patient pathways, healthcare system, competitive landscape, clinical trial regulatory environment, patient advocacy groups, Key Opinion Leaders (KOLs), site capabilities and past performance etc.
• Act as a trusted resource to investigators and study teams, guiding protocol expectations, recruitment strategies and best practices.
• Perform feasibility, site selection and provide support for sites during the study start-up process.
• Work closely with applicable internal teams, CRO CRAs and sites to support site enrolment.
• Assist with creation of country specific plans to target appropriate national patient support/advocacy groups to influence patient recruitment.
• Attend local medical/support group meetings and conferences as needed.
• Use local expertise to collaborate closely with investigator sites and vendors activities to ensure high quality feasibility data collected and qualified sites selected.
• Provide input on site level recruitment targets and recruitment methodologies.
• Work proactively with sites to resolve/mitigate any issues, share learnings from other sites, and manage any requests cross-functionally.
• Conduct monitoring oversight visits as needed.

Reporting to the Vice President of Clinical Operations, responsible for management of successful planning, implementation, and execution of studies in a Project Manager and Clinical Trial Manager hybrid role from feasibility through database lock.

• Conducted oversight of CRO and vendor management feasibility through study close-out.
• Pre-study development by establishing timelines, budgets, and forecasts to be presented to program leadership.
• Assisted in development of Clinical Operations department including standard operating procedure (SOP) development, creation of study start-up processes, template documents to prepare department to bring SSU monitoring in-house in the future.
• Drove collaboration with cross-functional stakeholders (Regulatory and Medical Affairs, Safety and QA), CROs, and vendors to ensure timely study deliverables and to identify any quality risks and implement mitigations.
• Development feasibility questionnaires, study monitoring plan, communication plan, study plan, protocol deviation plan, project management plan, investigator site file, and source documentation.
• Prepared, planned, managed, and reported studies through oversight of cross-functional study activities, identification and resolution of issues, and communication of study timelines.
• Participated in CRF design and User Acceptance Testing for CTMS, EDC and TMF software.
• Assisted with protocol and ICF development and implementation.
• Prepared, planned, managed, and reported studies through oversight of cross-functional study activities, identification and resolution of issues, and communication of study timelines.
• Conducted site evaluation through closeout visits and attended oversight visits with CRO to assure quality in study monitoring.
• Provided oversight and mentorship to junior clinical operations staff.
• Ensured consistency in processes across all programs and strict adherence to SOPs, regulatory requirements, and regulatory guidelines.
• Assisted in the preparation of mock Bioresearch Monitoring Information (BIMO) inspection readiness activities and audit activities.

• Performed and coordinated all aspects of the clinical monitoring and site management process for Phase III dermatological studies, feasibility through closeout. Conducted remote or on-site visits to assess protocol and regulatory compliance and managed required documentation for client-specific program.
• Ensured accuracy, timeliness, and completeness of investigator site file (ISF) by reconciling with trial master file (TMF). Advised investigator or physician site on requirements of archiving documents in accordance with local guidelines and regulations.
• Documented activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and clinical monitoring plan or site management plan.
• Supported subject or patient recruitment, retention, and awareness strategies. Tracked data and observations and resolved issues.
• Attended investigator meetings and sponsor meetings. Participated in global clinical monitoring and project staff meetings (inclusive of sponsor representation as applicable) and attended clinical training sessions according to the project-specific requirements.
• Verified investigational product (IP) via inventory and reconciliation, as well as reviews storage and security. Ensured IP was dispensed and administered to subjects or patients according to protocol. Resolved issues associated with blinded or randomized information. Applied knowledge of good clinical practices (GCP), local regulations, and organizational procedures to ensure IP was appropriately labeled or relabeled, imported, and released or returned.
• Conducted co-monitoring and SWAT visits as needed.

• Clinical Research Associate (CRA) consultant; monitored Phase I-III studies, feasibility through closeout, with 20-30 sites at any given time across multiple therapeutic areas.
• Monitored investigator sites with a risk-based monitoring approach, applying root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective and preventive actions to bring the site into compliance and decrease risks. Ensured data accuracy through source data review (SDR), source data verification (SDV), and case report forms as applicable through on-site and remote monitoring activities.
• Assessed investigational product through physical inventory and records review.
• Participated in investigator meetings as necessary. Identified potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiated clinical trial sites according to the relevant procedures to ensure compliance with protocol and regulatory and ICH-GCP obligations, making recommendations where warranted. Performed trial closeout and retrieval of trial materials.
• Conducted on-site file reviews per project specifications. Verified trial status tracking and progress update reports to the clinical trial manager (CTM) as required.
• Supported the project team by assisting in the preparation of client presentations and tools and sharing ideas and suggestions with team members.

• Clinical Research Associate (CRA) consultant; monitored Phase I-III studies, feasibility through closeout, with 20-30 sites at any given time across multiple therapeutic areas.
• Provided monitoring visits and site management for a variety of protocols, sites, and therapeutic areas.
• Administered protocol and related study training to assigned sites and established regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalated quality issues to clinical project manager (CPM), clinical research specialist (CRS), or line manager.
• Managed 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.
• Worked closely with site regarding recruitment plans and patient retention.
• Conducted study specific administrative duties including TMF upload and reconciliation, running site and study specific training reports, and extensive follow-up on site-specific action items and deviations.

• Performed and coordinated all aspects of clinical monitoring for RSV and COVID-19 vaccinations with enrollment between 200-500 per site and three sites under each study. Held role of CRA mentor, assuring that new CRAs were able to meet monitoring standards:
• Performed site selection, initiation, monitoring, and closeout visits in accordance with contracted scope of work and good clinical practice.
• Provided monitoring visits and site management for a variety of protocols, sites, and therapeutic areas.
• Administered protocol and related study training to assigned sites and established regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalated quality issues to clinical project manager (CPM), clinical research specialist (CRS), or line manager.
• Managed 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.
• Oversaw and mentored new CRAs to ensure they met monitoring standards.

• Reporting to the Director of Clinical Operations, managed clinical trial activities holding a hybrid role of Clinical Trial Manager and Clinical Research Associate in a medical device startup company focused on neurological deficits. Reported to the Director of Clinical Operations.
• Supported study design; created and reviewed study level protocol and informed consent form (ICF).
• Contributed to the development and review of all study-related documentation (patient-facing materials, source documents, study level protocol, informed consent, regulatory forms, and other study-specific documentation).
• Created, collected, and reviewed study start-up documentation.
• Established company processes including template monitoring reports and letters, monitoring expectations, and streamlined clinical operations.
• Conducted site selection, site initiation, routine monitoring, and study closeout visits.
• Interacted with contracted representatives, i.e., CRO and vendors, to ensure operational excellence and contractual obligations were met.
• Oversaw service providers to perform core data management functions including CRF, edit check development, user acceptance testing, data cleaning, reviewing listings, and database locking procedures.
• Created trial management files.

• Primary Clinical Research Associate for all study sites assigned to a late-phase clinical trial for health economics and outcome research (HEOR) for bacterial skin infections:
• Prepared initial regulatory document packages necessary for clinical site initiation. Collected and reviewed regulatory documents received from clinical sites to ensure all required documents were obtained, complete, and in compliance with ICH-GCP and local regulations.
• Performed on-site monitoring of clinical studies through review of case report forms (CRFs) and study records to report trends in safety, ensure timely reporting of adverse events and compliance with protocols, local regulations, ICH-GCP, and SOPs.
• Reviewed drug storage and drug accountability procedures in accordance with SOPs.
• Maintained trial master file (TMF) and investigator site files for the duration of the study, ensuring essential documents were filed appropriately and assisting in the file review and reconciliation process in preparation for inspection readiness.
• Maintained and updated project-related data in an existing database, i.e., clinical trial management system (CTMS).
• Worked within electronic data capture (EDC) system, creating monitor queries, resolving queries, and monitoring data against source documents. Assisted with EDC creation input during start-up.
• Reviewed patient information sheet (PIS), informed consent forms (ICFs), and data protection authorizations as required.
• Responsible for site management including communicating directly with investigative sites to provide study direction, answer questions, assess study recruitment rates, and respond to sponsor requests.

• Remote Clinical Research Associate position supporting multiple therapeutic areas and protocols within late-phase clinical trials.
• Identified, trained, initiated, and closed out study sites; conducted remote site monitoring visits or on-site visits as needed.
• Collected, reviewed, and approved regulatory documents required for site initiation and drug release in accordance with regulations and guidelines. Documents included but were not limited to regulatory document packages, ICFs, and advertisements.
• Negotiated contracts and budget.
• Served as internal contact for project management, sponsor, vendors, and consultants.
• Conducted remote site management activities; managed study sites, protocols, amendments, and deviations to assure accuracy of data and timely deliverables.
• Served as primary contact for sites and investigators participating in the study.
• Maintained, reviewed, and ensured adequacy of information and data contained in site management reports, tracking systems, and other site management documents.
• Reviewed drug storage and drug accountability procedures in accordance with SOPs.
• Assisted in development of site and patient enrollment strategies with project team; motivates sites to meet enrollment timelines.

• Study Start-up Associate in a full-service provider (FSP) setting. Conducted all start-up activities including budget and contract negotiations, informed consent review and approval, study maintenance, and study closeout:
• Collected, reviewed, and approved regulatory documents required for site initiation and drug release in accordance with all applicable regulations and guidelines. Documents included but were not limited to regulatory document packages, ICFs, and advertisements. Workload consisted of between 50-75 sites at any given time.
• Prepared, reviewed, and submitted Institutional review board (IRB) activities to ethics and regulatory and other relevant authorities and obtained all necessary authorizations and approvals pertaining to clinical trials.
• Performed independent quality review of submission packages. Collected and maintained current regulatory and competent authority (CA) and ethics committee (EC) submission information and similar information for other related organizations for the assigned countries and updated relevant ICON information system.
• Responsible for the translation and coordination of translations for documents required for submission (if applicable for region).
• Performed timely and accurate data entry of regulatory documents, submission status, and maintenance of country and investigator information in clinical trial management system.
• Managed assigned sites for investigator questionnaire completion and return, as well as regulatory document packet completion.
• Assisted and provided support to the SSU lead to maximizing submission effectiveness, minimize timelines, and ensure sponsor satisfaction.
• Negotiated contracts and budget.
• Distributed, reviewed, and approved site level informed consents.
• Assembled and distributed study materials to clinical and project teams, including materials to study sites, and for investigator meetings, e.g., investigator binders and vendors.
• Generated accurate and concise status reports to project team and managers.
• Conducted quality control audits of clinical study documentation (main study files, CRF files, monitoring files, etc.) as agreed per assignment.
• Attended sponsor, investigator, and project team meetings as required.
• Mentored new employees on start-up tasks, company processes, and sponsor systems.

• Study Start-up Associate in a full-service provider (FSP) setting. Conducted all start-up activities including budget and contract negotiations, informed consent review and approval, study maintenance, and study closeout:
• Collected, reviewed, and approved regulatory documents required for site initiation and drug release in accordance with all applicable regulations and guidelines. Documents included but were not limited to regulatory document packages, ICFs, and advertisements. Workload consisted of between 50-75 sites at any given time.
• Prepared, reviewed, and submitted Institutional review board (IRB) activities to ethics and regulatory and other relevant authorities and obtained all necessary authorizations and approvals pertaining to clinical trials.
• Performed independent quality review of submission packages. Collected and maintained current regulatory and competent authority (CA) and ethics committee (EC) submission information and similar information for other related organizations for the assigned countries and updated relevant ICON information system.
• Responsible for the translation and coordination of translations for documents required for submission (if applicable for region).
• Performed timely and accurate data entry of regulatory documents, submission status, and maintenance of country and investigator information in clinical trial management system.
• Managed assigned sites for investigator questionnaire completion and return, as well as regulatory document packet completion.
• Assisted and provided support to the SSU lead to maximizing submission effectiveness, minimize timelines, and ensure sponsor satisfaction.
• Negotiated contracts and budget.
• Distributed, reviewed, and approved site level informed consents.
• Assembled and distributed study materials to clinical and project teams, including materials to study sites, and for investigator meetings, e.g., investigator binders and vendors.
• Generated accurate and concise status reports to project team and managers.
• Conducted quality control audits of clinical study documentation (main study files, CRF files, monitoring files, etc.) as agreed per assignment.
• Attended sponsor, investigator, and project team meetings as required.
• Mentored new employees on start-up tasks, company processes, and sponsor systems.