Adrian Lang

• Senior Clinical Research Associate (CRA) with 11 years of experience within the CRO industry in different positions, including Clinical Research Associate, Clinical Trial Specialist, and Clinical Site Specialist.
• As a CRA, I worked on Phase I-IV observational and registry trials in oncology, cardiology, vascular, neurology, medical devices, nervous system, and other therapeutic areas. Gained significant experience in cardiomyopathy, multiple sclerosis, and heart failure studies. Performed remote and onsite IMVs, SIVs, and COVs with reduced or 100% SDV. Familiar with Risk-Based Monitoring and AIM. Experienced with client-specific systems from trial management, including EDC and Vestigo.
• THERAPEUTIC AND INDUSTRY SUMMARY:

Therapeutic Units & Indications (YRS): Cardiovascular, Metabolic, and Critical Care: Cardiomyopathy (1y), General Medicine: Breast Implants (1y) Neuroscience: Multiple Sclerosis (3y)

• Study Phases: Phases I-IV, Open Label, Double-Blind, Randomized, Registry, Observational, Multicenter, Safety, Post-Marketed, Parallel Cohort, Non-Interventional.
• Patient Populations: Adults, Pediatrics, Elderly
• Global/Regional Scope: North America (USA)
• Additional Highlights: Start-up CRA experience in feasibility and start-up activities, including PSVs in the following indications: Alzheimer's disease, Fabry disease.

Education:

• Northwest Missouri State University, Maryville, MO, USA.

BS, Business Management, August 2011.

Professional Experience:

Transformative Pharmaceutical Solutions (TPS), Blue Bell, PA:

• Senior Clinical Research Associate (CRA), Nov 24, 2024 - Present: Senior Clinical Research Associate responsible for overseeing clinical trials to ensure they are conducted efficiently, ethically, and in compliance with regulatory standards. Responsible for visiting clinical trial sites to ensure proper study conduct, data collection, and documentation. Ensure assigned clinical trials comply with ethical standards, institutional policies, and regulatory guidelines. Responsible for monitoring patient safety and adverse event reporting. Responsible for verfiying data accuracy by cross-reference source documents and case reports forms (CRFs). Ensures timely and accurate data submission to regulatory bodies. Prepare detailed reports and present findings to Sponsors. Facilitate communication between sponsors, regulatory authorities, and clinical trial sites. Lead site initiation, monitoring visits, and close-out visits. Responsible for the oversite of Investigational Product (IP) accountability, drug receipts, and drug dispensing.

ICON Clinical Solutions, Raleigh, NC.

Senior Site Manager, Aug 2023 - Sep 2024

Senior Site Manager, responsible for the successful management of investigator site and monitoring activities for assigned clinical studies throughout the trial lifecycle. Responsible for conducting monitoring visits (SIVs, PSVs, routine monitoring, co-monitoring, and close-out visits), ensuring quality oversight and compliance with the study protocol. Assists with investigator/site identification, Ethics Committee submission, site contract, and budget negotiation. Provided protocol and study-related training to assigned site staff. Develops effective relationships with investigator site staff to ensure key clinical metrics are met. Ensures the integrity of clinical data through the ability to sufficiently maintain site track records, and by working diligently to execute protocol guidelines. Responsible for the oversight of IP accountability, drug receipts, pharmacy protocol management, dispensing, returns, quarantine inventory, lot number, and cycle counts, through remote monitoring (Vestigo, Jira, Time Tracker) and on-site pharmacy review.

PPD, Wilmington, NC, USA.

Senior CRA, October 2020 - August 2023

Worked on four Phase 1 through 3 multicenter, randomized, double-blinded studies in Cardiology, Vascular Disease, Cardiomyopathy, Hypertension, and Heart Failure in the adult and pediatric populations. Conducted a combination of on-site and remote visits, including site initiation, interim monitoring visits, and close-out visits, with 100% and reduced SDV in accordance with the monitoring plan, review of IP accountability, essential and site document management, site training, and query resolution support. Responsible for the CRF reviewed in both paper and electronic forms. Ensured that the trial is conducted in accordance with the protocol, ICH, and GCP guidelines. Escalated observed deficiencies and issues to clinical management as needed, provided site progress reports to the Sponsor and clinical team, issued and followed up on findings, participated in team meetings, offered support for database lock, and ensured study systems and site facilities were adequate per obligations, as well as other work and initiatives for process improvement as requested.

United BioSource Corporation (UBC), Kansas City, MO, USA.

Clinical Research Associate (CRA), Oct 2018 - Sep 2020

Worked on 8 Phase I - IV Registry, post-marketed, observational, nervous system (multiple sclerosis), cardiology/vascular disease (hypertension, cardiomyopathy), and device (breast implants) clinical trials in elderly, adult, and pediatric subjects. Conducted site initiation visits, interim monitoring visits, and close-out visits, both remote and on-site, in accordance with regulatory and project-specific guidelines. Performed 100% or reduced SDV during on-site visits using EDC, paper, and electronic CRFs. Experience with reviewing Investigator Site Files on site, as well as safety data, to ensure AE/SAEs were reported timely and accurately. Maintained consistent site personnel contact, query resolution provision, and training. Familiar with AIM and risk-based monitoring systems. Ensured that trials were conducted properly per the protocol, ICH-GCP guidelines, and SOPs. Managed site trial master files for assigned sites. Reviewed clinical documents, including the protocol, ICF, CRF, and subject diary. Ensured that the follow-up on site issues and action items was completed per sponsor timelines. Performed reconciliation and management of clinical trial supplies. Participated in internal sponsor meetings.

CLINICAL TRIAL SPECIALIST II, MAR 2015 - OCT 2018

Worked on a Phase III multicenter, parallel cohort, non-interventional Nervous System (Multiple Sclerosis) trial in adult subjects. Managed regulatory and institutional review board activities, including preparing, distributing, evaluating, collecting, and approving documents required for regulatory compliance and IRB submission. Assisted in study startup and study maintenance for study sites. Created and reviewed project planning documents, including but not limited to the essential document review plan, site management plan, and project plan. Assisted with remote SIV monitoring and follow-up activities. Conducted site training in GCP, and protocol decision-making in key aspects of the study. Served as the liaison between the Sponsor, CRO, and Investigator Site. Participated in sponsor and project team teleconferences regularly. Assisted the CRA team in database lock and interim monitoring visits.

CLINICAL TRIAL SPECIALIST (CSS) I - Dec 2013 - MAR 2015

Worked on two Phase III observational, safety, and efficacy Nervous System (Multiple Sclerosis) trials in adult patients. These trials evaluated the safety and effectiveness of a specific approved product in adult patients with relapsing/remitting multiple sclerosis. Created trial management files, maintained essential documents in compliance with FDA regulations, ICH-GCP, and local laws. Managed ongoing collections and quality review of updated essential documents for submission to the TMF. Ensured TMF was audit-ready, as well as preparing, packaging, and archiving such documents at study closure. Verified accurate and timely electronic data entry of study subject information, as well as reviewed electronic data to ensure protocol deviations were reported to the IRB appropriately. Managed sites in meeting subject enrollment targets, per contractual obligations. Participated and supported project leadership during the interim analysis to ensure sponsor deadlines were met. Collaborated with sites to achieve query resolution. Acted as the main point of contact between the site, CRO, and Sponsor. Preserved document security and integrity, as well as processed and distributed site payments.

Professional Development:

Clinical Research Associate Academy, Kansas City, Missouri, USA, United BioSource Corporation, Oct. 2018.

Completed the PPD Clinical Foundation Program in December 2020.

Languages:

Native Tongue: English

Therapeutic Experience and Expertise:

Cardiology/Vascular Disease: Heart Failure, Hypertension, Cardiomyopathy (Pediatric)

Devices: Neurology (Nerve Repair) Breast Implants

Nervous System: Multiple Sclerosis

Oncology: T-Cell, Brain Tumor