Clinical Research Associate

Mark Scofield, MS, CCRA 619-***-**** ****.********@*****.***

San Diego, CA, USA linkedin.com/in/markscofieldccra

CLINICAL RESEARCH ASSOCIATE

Proven ability to manage and monitor clinical research sites and personnel across a variety of therapeutic areas from Phase I through Phase IV, specializing in Phase III. Possesses in-depth knowledge and ability to manage project scope, time and cost issues, project quality, human resources, communications, and project risks. Thorough ability to conduct Site Feasibility, Site Qualification Visits (SQV), Site Initiation Visits (SIV), Routine Interim Monitoring Visits (IMV/RMV), and Close-Out Visits (COV) in compliance with FDA, GCP, SOPs, ICH and OHRP guidelines and regulations. Training and mentoring of CRAs for site-management and supervisory excellence.

Experienced in Phase II-III Clinical Trials in: CNS, Psychiatry, Ophthalmology, Respiratory (Asthma, RSV), Oncology (Prostate Cancer), Immunology and Infectious Diseases including HIV and Covid-19. (CNS/Psychiatry experience includes Alzheimer’s Disease, Major Depressive Disorder, Narcolepsy, & Migraine studies).

Areas of Expertise

■ Remote Risk-Based Monitoring using CTMS, EDC ■ Good Documentation Practices with ALCOA-C

■ Risk & Protocol Deviation Identification & Mitigation ■ PMI PMP (Project Management Professional) Training

■ CRF Review & Source Document Validation ■ SOP Development, Implementation & Maintenance

■ Establishing Effective Relationships ■ Regulatory Document expertise including FDA 1572 & ICFs

■ SQV, SIV, RMV, COV Monitoring Visits ■ The Drug Development Process Phase I-IV

■ Good Clinical Practices (GCP/ICH/ISO 14155) ■ Training, Mentoring and Supervision of Staff

PROFESSIONAL EXPERIENCE

Senior Clinical Research Coordinator – NAVY MEDICAL CENTER, SAN DIEGO San Diego, CA (February 2025 – present)

Coordinate between Principal Investigators and Clinical Investigations Department to ensure that clinical research is performed in accordance with federal regulations and sponsoring agency policies. Assist with EIRB submission. Obtaining informed consent. Perform secondary chart reviews using MHS Genesis and other military health databases.

Senior Clinical Research Associate – ICON/DOCS CLINICAL RESEARCH Houston, TX (May 2021 – Oct 2023)

Monitoring of a clinical research study for Respiratory Syncytial Virus (RSV) including study start up activities and site initiation visits (SIV) for 13 sites. Creating clinical reports in compliance with FDA, ICH/GCP regulations and sponsor requirements. Training of research site staff in study procedures and systems to ensure that the clinical trial is run in compliance with protocol requirements while ensuring patient safety and privacy is maintained. Participation in Investigator Meeting and weekly team meetings.

SELECTED ACCOMPLISHMENTS:

Volunteered to take on extra assignments, conducting 13 SIV visits in a 6-week period for a lightspeed RSV vaccine study.

Managed to have 3 of the highest and fastest enrolling sites nationwide, each with over 60 patients while other sites were in startup.

Senior Clinical Research Associate – LOTUS CLINICAL RESEARCH Houston, TX (January 2021-May 2021)

Responsible for the management of clinical research studies at the site level to ensure successful completion of study related activities in compliance with FDA, ICH/GCP, and protocol requirements. Creating and maintaining up-to-date and accurate clinical reports and regulatory study documents. Supervision and managing of research sites to ensure study staff is performing their duties properly while patient’s rights and privacy are being protected. Liaison between research sites and sponsor company. Review of eCRF data and source documentation in EMR databases for accuracy, completeness, attributable, original, and contemporaneous.

Performing remote and on-site Site Qualification Visits (SQV), Site Initiation Visits (SIV), and routine Interim Monitoring Visits (RMV/IMV) per sponsor and regulatory agency requirements.

SELECTED ACCOMPLISHMENTS:

Reviewed and compiled documents for Common Technical Document (CTD) modules 2 through 5 in alignment with requirements applicable for submission to the FDA.

Conducted SQV and SIV successfully, training a staff of 30 research professionals in protocol specific requirements for post-surgical pain studies.

Clinical Research Associate – (Contractor) Houston, TX (August 2019-January 2021)

Independent contracting with ClinSmart, LLC and Monitorforhire.com conducting site qualification, initiation, start-up, interim monitoring, and close-out visits for protocols across various therapeutic areas including, Covid-19, infectious and respiratory diseases, and ophthalmology. Ensured patient safety by verifying site adherence to informed consent procedures, protocol requirements, SOPs, ICH, GCP, and FDA guidelines and regulations. Perform on-site and remote monitoring using CTMS and EDC systems in compliance with 11 CFR 21. Providing outstanding customer service and proactive problem resolution.

Performing remote and on-site source document verification (SDV), tracked and reported SAEs and AEs to PI and IRBs, and prepared site visit reports. Reviewed documentation in compliance with protocols, SOPs, monitoring plan, and regulatory requirements. Maintained complete and accurate Trial Master Files (TMF). Assisted with regulatory requirements for submission. Management of site activities. Maintain close contact and open communications collaborating with other CRAs and study staff to ensure adequate training and proper conduct in Good Clinical Practices.

Principal Trainer–VINNELL ARABIA (A NORTHRUP GRUMMAN SUBSIDIARY) Riyadh, Saudi Arabia – (December 2015–May 2018)

Led day-to-day operations directing training department as 2nd in Command at King Khalid Military Academy as central point of contact. Interviewed, mentored, and led team of 30 employees, developed Performance Improvement Plans (PIP), Daily, Weekly, Monthly Reports. Staff supervision. Assisted in planning, developing, coordinating, and evaluating staff, projects and programs. Provide input on budget. Lead Professional Development projects. Provided leadership through trust building, conflict management, and active listening. Functional expertise of Microsoft Office including Word, Excel, PowerPoint, and Outlook.

SELECTED ACCOMPLISHMENTS:

Played key role in establishing the first instructional training program in Medical English for hospital employees at the largest medical facility in Riyadh as a key contributing member of the curriculum development team.

Managed $1.1M language lab installation project on time and within budget, leading to 15% increase in trainee performance.

Education

ARIZONA STATE UNIVERSITY

Master of Science (MS), Clinical Research Management, 2021

UNIVERSITY OF CALIFORNIA, SAN DIEGO

Bachelor of Arts (BA) in Sociology: Research Methods and Statistics.

SELECTED Industry Certification & Training

Association of Clinical Research Professionals (ACRP) Certified Clinical Research Associate (CCRA), May 2020

Project Management Institute Project Manager Professional (PMP), anticipated March 2021 completion

NIH Clinical Pharmacology, 2020 NIH Principles and Practices of Clinical Research, 2020

Fundamentals of Immunology, 4 course specialization, Rice University, 2020

National Institute of Allergy & Infectious Diseases (NIAID) Good Clinical Practices Course, April 2020

Project Management: The Basis for Success, University of California, Irvine, 2019

Contact this candidate