Enid Martir
Green Lane
Overview
17
17
years of professional experience
1970
1970
years of post-secondary education
Work History
Sr. Project Coordinator
UBC
Virtual
11.2023 - Current
- Maintain Accurate information and inform the traveling nurse assigned too.
- Update CRM with patient information and visits
- Coordinate Lab pick up and inform the nurse for that visit
- Maintain and track supplies
- Maintain and track assigned visits during the week
- Communicate with scheduling team regarding visits
- Decentralized Study
Sr. Clinical Trial Specialist
UBC
Virtual
07.2022 - 11.2023
- Manage Regulatory and Institutional Review Board (IRB) Activities:
- Prepare, distribute, collect, evaluate, and approve regulatory documents required for regulatory compliance and IRB submission.
- Submit regulatory documents to Central IRBs and manage site submissions to Local IRBs; confirm IRB approval is received and documented.
- Conduct regulatory packet submissions to clients for site approval and drug release.
- Create and review project planning documents including but not limited to Essential Document Review Plan (EDRP), Site Management Plan, and Project Plan.
- Track milestones, generate study metrics, and provide written and verbal updates to internal and external customers.
- Confirm sites have notified IRB of closure and final subject status in compliance with regulations.
- Confirm sites have returned or destroyed study drug and other study supplies as required.
- Train sites on their continued contractual, regulatory, and legal obligations.
- Conduct Site Management Activities:
- Evaluate sites to determine interest, adequate subject population, facilities, staff, and qualifications to conduct a study.
- Execute confidentiality agreement, contract, and budget negotiation with sites.
- Provide site training and access to required systems, including vendor systems.
- Provide site training and guidance in reference to protocol compliance.
- Provide site training and guidance in reference to regulatory requirements and ensure compliance.
- Manage site relationships to ensure positive interactions through routine site contact.
- Evaluate site performance and compliance with required FDA regulations, ICH/GCP, and local laws.
- Confirm sites are compliant with subject rights and privacy requirements.
- Ensure sites meet subject safety reporting regulations: subject safety information is disseminated appropriately by evaluating consistency, quality and timeliness of serious adverse events reported by the site and submission to the IRB.
- Manage site inventory of study drug, laboratory supplies, and any other study materials to ensure sites have sufficient inventory to conduct study activities without delay.
- Escalate potential misconduct, fraud, or noncompliance by sites to Project and Functional Management and Quality Assurance.
- Instruct sites on study or protocol requirements and determine subject qualification based on subject eligibility parameters.
- Track study activities, milestones, document receipt, and payment status in CTMS.
- Participate in internal/external project team meetings.
- Assist with other duties as assigned.
- Essential Document Management and Audit Readiness:
- Create Trial Master Files (TMF) and maintain essential documents in compliance with FDA regulations, ICH/GCP, and local laws.
- Manage ongoing collection and quality review of updated essential documents for submission to the TMF.
- Preserve document security and integrity.
- Ensure Regulatory Authority and Client audit readiness of TMF.
- Prepare, package, and archive TMF at study closure.
- Perform Remote Monitoring Activities:
- Verify accurate and timely electronic data entry of study subject information.
- Review electronic data and ensure protocol deviations are reported to IRB as appropriate.
- Collaborate with sites to achieve query resolution of electronic data.
- Manage sites in meeting subject enrollment targets to meet contractual obligations.
- Conduct remote monitoring visits and complete requisite visit reports.
- Facilitate Payment Distribution to Investigative Sites:
- Contribute to project plans outlining payment strategy.
- Evaluate data to identify milestones ensuring sites are paid according to the contract.
- Process and distribute investigative site payments.
- Job Duties Specific to Senior CTS:
- Demonstrates ability to successfully lead, mentor, and train CTSs.
- Provides feedback on CTS performance regarding department goals and objectives.
- Proficient at CTS duties with minimal oversight.
- Exhibits good decision-making skills utilizing all available resources for determining positive outcomes.
- Develops solutions to a variety of moderate to complex issues, analyze current policies and procedures, and recommend changes as needed.
- Demonstrates thorough knowledge of clinical research, industry standards, practices, and regulations.
- Demonstrates understanding and application of UBC systems and work environment.
- Generates and review project specific metrics as needed.
- May serve in a leadership/mentoring role for a specific project.
Team Lead CPC/Clinical Project Coordinator III
Celerion
Virtual
06.2020 - 05.2022
- Lead and supervise newer Clinical Project Coordinators
- Reviewing and Maintaining Timesheets
- Approving request of time off
- Assign CPCs to new studies as applicable
- Assigning tasks on certain studies
- Develop, mentor, manage CPC staff to improve skills and growth for potential to move to next level.
- Perform annual appraisals, define the performance objectives and advocate individual career developments, responsibility and accountability.
- Monitor and evaluate workload
- Maintain a positive, open-door policy with my team.
- Maintain a Renal/Hepatic tracker of studies and sites
- Maintain a tracker of the entire GCD team experience with Renal, Hepatic, tobacco, devices vaccines.
- Discuss issue or concerns with Senior management
- Support CPMs and CRA’s allocated to studies I am allocated
- Preparation of submissions to IRBs
- Support and maintain of the studies
- Management of essential study and site documents
- Upload documents into Veeva for the studies TMF & CTMS.
Clinical Project Coordinator II
Celerion
Virtual
03.2019 - 06.2020
- Support day-to-day management of studies, ensure within the Study Team that project/study tasks are delivered in time, within the budget, and according to Sponsor/Client expectations, in close cooperation with designated Project Team
- Support the implementation and maintenance of studies; help ensure Sponsor and Investigator obligations are met; ensure compliance with applicable regulatory requirements (including local law) as well as Good Clinical Practice
- Support in document management (creation, review, collection, filing, forwarding) including submission documents, meeting agenda/minutes and Trial Master Files, from Pre-study Phase to Study Closure
- Support CRAs by (but not limited to) preparing checklists, ensuring compliance with completion timelines, updating relevant tracking sheets
- Support in Celerion’s internal process improvement
- Maintain the lab kits tracker for studies and Clinical Ink system accesses
- Support site feasibility and site qualification visits in order to select qualified sites
- Support to prepare documents for Site Initiation Visits (SIVs), such as presentation slides
- Support to prepare documents for Monitoring Visits
- Support to prepare documents for Close-out Visits
- Perform content review and quality checks of received documents
- Cooperate with central TMF team to keep TMF up-to-date and track filed documents
- Support query resolution by sites in a timely manner
- Support Serious Adverse Event (SAE) reporting according to study specifications
- Support in document/review study status, site enrollment status
- Interact with Sponsor/Client and participate in Sponsor/Client meetings as necessary
- Participate and demonstrate proactive involvement in project/study meetings and other activities enhancing project progress
Clinical Trials Associate
Celerion
Virtual
05.2009 - 03.2019
- Support the execution of Phase I-IV studies including study start up, site management, and management and monitoring activities in compliance with principles of ICH-GCP guidelines. SOPs
- Support day-to-day management of studies, ensure within the Study Team that project/study tasks are delivered in time, within the budget, and according to Sponsor/Client expectations, in close cooperation with designated Project Team
- Conduct regulatory packet submissions to clients for site approval and drug release.
- Support the implementation and maintenance of studies; assist so that Sponsor and Investigator obligations are met and are in compliance with applicable regulatory requirements (including local law) as well as Good Clinical Practice
Clinical Trial Assistant
Icon Clinical Research
North Wales
- To assist the clinical research teams be it the PM or CM in ensuring the most effective and efficient conduct of clinical research studies by providing administration and project tracking support.
- To support the CRA and assistance to PM and PD teams in completion of all required tasks to meet departmental and project goals.
- To assist project teams with study specific documentation and guidelines as appropriate.
- To assist in quality control audits of clinical study documentation
Education
Bachelor of Arts - IT Management, Business
St. David’s
St. David’s, PATimeline
Sr. Project Coordinator
UBC
11.2023 - Current
Sr. Clinical Trial Specialist
UBC
07.2022 - 11.2023
Team Lead CPC/Clinical Project Coordinator III
Celerion
06.2020 - 05.2022
Clinical Project Coordinator II
Celerion
03.2019 - 06.2020
Clinical Trials Associate
Celerion
05.2009 - 03.2019
Clinical Trial Assistant
Icon Clinical Research
Bachelor of Arts - IT Management, Business
St. David’s
Performance And Proficiencies
> 13 years, Tobacco, Hepatic, Renal, Pediatric Devices, Oncology, Bioequivalence, Schizophrenia application, Asthma-Devices, Decentralized studies, Phases I, II, III, IV, North America, Canada, United States, English