CLAUDIA A.

VERA
CERTIFIED CLINICAL RESEARCH PROFESSIONAL
(310) 666-1031 Huntersville, North Carolina, US - Willing to relocate
Claudiavera2b@gmail.com Bilingual: Fluent English/Spanish

P R O F I L E
A Certified Clinical Research Professional with a meticulous regard for detail and accuracy. Ready to bring 15 years of experience in
coordinating over 50+ phase I- IV clinical research trials for industry sponsored, investigator-initiated, and NIH funded trials.
Experience with multiple FDA and IRB Site Audits. Demonstrated ability in supporting the management and coordination of the key
aspects of a research trial life cycle at the site level. Settings have included: private, academic, and government research institutions.
Experience in trials in a wide range of therapeutic areas and diverse patient populations.
S K I L L S
 Robust knowledge of ICH GCP and FDA regulations governing biopharmaceutical research
 Skilled in problem-solving, organization, critical thinking, and decision-making
 Knowledge of quality assurance processes and procedures
 Demonstrated skill in prioritizing workflow to meet deadlines, often under pressure of conflicting demands, while maintaining
accuracy and effectiveness of work
 Self-starter with ability to work remotely with a high degree of independence.
 Versatile with MS Office applications (Word, Excel, PowerPoint) and SharePoint cloud services
 Versatile with EDC (Inform, Medidata RAVE, Perceptive Data labs, Oracle RDC, Redcap)
 Experience with CTMS and eTMF
 Strong Phlebotomy (hard sticks) , biospecimen collection/handling/processing/shipping
E D U C A T I O N
Undergraduate Senior / BS Health Science/Health Care Leadership
Los Angeles Pacific University/ Dean’s List /3.977 GPA Oct 2022- April 2024
Associate of Arts Degree /General Science
Santa Monica College, California / Dec 19,2017
High Honors

Certification/Medical Assistant Program

Bryman College, California /Jan 2001
C E R T I F I C A T I O N / T R A I N I N G
Duke University School of Medicine/
Regulatory Affairs ORAQ 9/19/23-10/27/23
 Drug Development and FDA Meetings
 Applicability of FDA Drug Regulations to Clinical
Studies
 IND Content, Format, Review and Maintenance
 Medical Device Development and FDA Meetings
 Applicability of FDA Device Regulations to
Clinical Studies
 IDE Preparation, Submission, and Maintenance
Certificate/The Oncology Monitor
VIARES/ January 2024
Certificate/Clinical Research Associate
VIARES/ August 2023
Certificate/Clinical Trial Associate/Trial Master File Specialist
VIARES/ August 2023
Certified Clinical Research Professional
ACRP/NOV 2022 (Expires NOV 30,2024)
Certificate/IATA
Mayo Clinic / Expires OCT 13, 2024
Certificate of Appreciation/Medical Assistant of the Year
UCLA Health System/ Awarded OCT 18, 2016
 CLAUDIA A. VERA
WORK EXPERIENCE

Research Quality Assurance Coordinator/Regulatory Coordinator

Joint Muscle Medical Care Research Institute/Charlotte, NC.,/Aug 2019- Nov 2023

Serve as an expert resource on quality improvement and provide advice on optimal strategies for performance improvement and
compliance in accordance with GCP and FDA regulations. Support site for root-cause-analysis for corrective and preventative
action plans. Create source documents with an emphasis on ensuring protocol adherence, subject safety, efficiency, and protection
of data integrity. Preparation, submission, and maintenance of regulatory applications/submissions to fulfill research requirements
of a given trial during a life cycle (i.e., new study submission, study modification, safety reporting, reportable events, continuing
review, and close-out reports).

Audit and Compliance:

 Oversaw For Cause FDA Audit and performed pre-audit QA functions
 Reviewed and approved investigations, RCA,CAPA and EC plans for quality events
 Co- led inspection preparation meetings
 Write SOPs
 QA Regulatory Binders to ensure an Audit Ready State and research training/qualification compliance.

Data Integrity and Verification:

 Identified discrepant data capture and ensured appropriate corrections were made
 Verified subject safety and site adherence to FDA regulations, ALCOA+, ICH/GCP guidelines, and
protocol-specific requirements
 Conducted Source Data Verification

Documentation and Reporting:

 Maintained accurate progress reports and other spreadsheets for tracking QA review and approval.
 Source document creation for rheumatology phase II-IV research studies, resulting in no preventable
protocol deviations for over 40 research trials.

Training and Mentorship:

 Identified and assisted in developing training programs for study staff and supporting departments.
 Helped develop, coach, and mentor junior colleagues, generating enthusiasm.

Regulatory:
 Act as the primary point of contact for regulatory agencies, sponsors, and study monitors regarding regulatory
matters
 Prepare, submit, and maintain regulatory documents for study approvals and any other submissions required until
study closure
 Organize and maintain the regulatory binder, ensuring completeness and accuracy of essential documents

.
 CLAUDIA A. VERA
WORK EXPERIENCE
Clinical Research Coordinator
UCLA Semel Institute / Veterans Affairs /Los Angeles, CA./Apr 2017-Aug 2019
Responsible for overall operational management of clinical research activities for psychiatry related studies in phase II-IV at
UCLA and at the VA. Direct responsibility for implementing a diverse portfolio of research activities for studies which
included multicenter clinical trials (both NIH and industry-sponsored) and local investigator-initiated clinical trials. Close
collaboration with the Principal Investigator (PI) of each study, to facilitate timely study progress reporting to the PI and
enabling appropriate PI oversight and study management for safe and accurate completion of protocol required procedures in
accordance with standard operating procedures, governing regulations, and study documents.

Project Management
 Led weekly project management clinical trial meetings.
 Emphasized recruitment/retention strategies, business development, efficiency, and risk mitigation plans

Protocol Review:
 Collaborated with the Principal Investigator and study team in the review and interpretation of study protocols.
 Ensured regulatory compliance in the implementation of study protocols.
 Identified and addressed potential regulatory issues related to study protocols.

Regulatory Compliance and Standardization:

 Implemented quality assurance processes to ensure regulatory compliance and data integrity.
 Conducted internal audits to identify and rectify potential regulatory issues.
 Worked closely with the Institutional Review Board (IRB) or Ethics Committee to obtain and maintain ethical
approval for research studies.
 Ensured timely submission of required documentation to the IRB.
 Prepared, submitted, and maintained regulatory applications/submissions throughout the trial life cycle.
 Managed new study submissions, study modifications, safety reporting, reportable events, continuing reviews, and study
closeouts.
 Created Standard Operating Procedures (SOPs) to address Corrective Action and Preventive Action Plans(CAPAs).
 Performed Quality Assurance/Quality Control (QA/QC) functions.

Subject Management
 Managed subjects throughout the trial life cycle.
 Conducted subject recruitment, obtained consent, built rapport, reviewed medical/surgical and medication history,
enrolled subjects, and managed drug dispensing/accountability.
 Conducted clinical procedures (vitals, EKGs, biospecimen collection/handling/processing) under the supervision of the
Principal Investigator.
 Performed structured interviews and tracked patient interventions.

Mentoring and Training:

 Mentored junior staff on subject protections for clinical research compliance.
 Led training sessions for junior staff on regulatory compliance.

Communication and Collaboration :

 Worked collaboratively with internal and external stakeholders such as physicians, clinical research specialists,
leaders, family members, key care givers and any ancillary medical personnel/departments as appropriate.
 CLAUDIA A. VERA
WORK EXPERIENCE

Medical Assistant
UCLA Santa Monica Bay Physicians/Los Angeles, CA./ Feb. 2013 - Apr.2017
Participated in the total patient care in the ambulatory setting in a multi-specialty office (Family Medicine, Sleep Medicine,
Rheumatology, and Pulmonary Medicine, and Urgent Care). Interfaced with patients, families, and physicians in the
coordination of all patient care services for a diverse patient population.

Patient Care:
 Rooming of patients, which involves adeptly observing for abnormal clinical symptoms, obtaining vital signs, and
reviewing medications.
 Administering oral, IM, intradermal, and subcutaneous medications.
 Wound irrigation and dressing changes

Clinical Procedures:
 Setting up and assisting physicians with clinical procedures, including bronchoscopy, pap smears, suturing,
incision/draining, and mole removal
 Performing clinical procedures within MA scope of practice: ear lavage, EKG, Vitals, Snellen chart test, Audiometry

Diagnostic Testing:
 Performing accurate patient sample testing for waived tests (POCT).
 Conducting phlebotomy and sample processing.
 Spirometry

Referral Coordination:
 Submitting referrals for various clinical needs, such as consultations, DME supplies, home health, hospice care,
specialty medications/prior authorizations, and procedural requests.

Inventory Management
 Maintained stock of clinical supplies and medications

Quality Assurance
 Performing quality checks and calibration of equipment.
 Participating in departmental process improvement activities, i.e., planning, measuring/monitoring, assessing, and
improving.
 Cleaning and sterilization of instruments used in clinical procedures

Recognition and Leadership:

 Nominated for Medical Assistant of the Year by UCLA Physicians in practice (2016)
 Often sought as the go-to person to solve problems and provide guidance for challenges
 Implemented efficient workflow processes
 Encouraged positive customer service experience
 Mentored junior colleagues
 CLAUDIA A. VERA
WORK EXPERIENCE
Site Director
Axis Clinical Trials /Los Angeles, CA./April 2009 - Feb. 2013

Responsible for taking the lead mentoring role of clinical research coordinators and research assistants, quality improvement,
operations, management, coordination, and project management planning. Oversaw direct reports of 20+ research employees.
Supported a culture of continuous improvement, quality, and productivity.

Team Management:
 Managed all clinical research staff, including investigators, coordinators, lab, and research assistants.
 Provided timely feedback on employee performance, helping to develop team members' skills where needed, and
addressing performance problems.
 Assisted with organizing and conducting Staff Meetings at regular intervals and addressed issues discovered at meetings.
 Ensured all personnel obtained detailed knowledge of all components of the study protocol through review and training
before the study effective date.
 Set clear goals for the research team to align with study objectives and overall departmental aims.
 Tracked and monitored progress towards goals, providing support and guidance as needed.

Workflow Efficiency:

 Set clear expectations for the research team.

 Designed efficient workflows and created tracking mechanisms.
 Mentored and motivated team members to perform at a peak level.

Subject Screening and Enrollment:

 Provided direction and support to the research team during subject screening.
 Ensured qualified subjects were identified and enrolled in the study in a timely manner.
 Developed and implemented an effective enrollment plan to ensure subject enrollment consistent with the sponsor's
protocol and enrollment period.

Quality Assurance and Compliance:

 Conducted QA/QC audits and source data verification reviews.

 Wrote SOPs (Standard Operating Procedures) and created corrective action plans.
 Reported IRB reportable findings.
 Ensured staff compliance with research-specific training.
 Ensured adherence to regulatory requirements and standards in clinical research.
 Performed quality checks to ensure protocol compliance

Audit Oversight:
 Oversaw 2 FDA site audits and numerous routine IRB and Sponsor Audits.

Collaboration with Sponsors and CROs

 Built and maintained relationships with study sponsors and collaborators.

Risk Management:
 Identified and mitigated risks associated with research activities.

Continuous Process Improvement

 Implemented strategies for continuous improvement in research processes and outcomes.
 CLAUDIA A. VERA
WORK EXPERIENCE
Lead Clinical Research Coordinator
Axis Clinical Trials /Los Angeles, CA./Jan. 2007 – Feb 2013

Lead Clinical Coordinator for high enrolling fast-paced clinical research site for industry sponsored research projects in Phase
I - IV in various specialties, such as: neurology, cardiology, urology, infectious disease, gastroenterology, gynecology,
pulmonology, endocrinology, dermatology, and rheumatology.

Project Management and Team Leadership

 Oversaw large teams for high-enrolling studies (i.e., 1000+ participants).
 Coordinated the conduct of all key research activities.
 Managed and led teams in the execution of clinical research projects.

Study Operations:
 Coordinated recruiting, consenting, medical history, and medication review
 Handled subject enrollment, AE/SAE reporting, and IP dispensing/Drug Accountability.
 Conducted a wide range of clinical procedures within scope of medical assistant (phlebotomy, pap smear assisting, colposcopy
assisting, urinary catheter insertion, colposcopy/urinary bladder injection assisting, tattoos for derm studies, slide prep,
Spirometry, Injections, biospecimen collection/processing/shipping).

Regulatory:
 Managed the gamut of IRB submissions for the entire trial life cycle (study start up, modifications, protocol deviations, SAEs,
Continuing Reviews, Study Close-Out)

EDC:
 Created source documents and ensured data entry and query resolution.

Research Assistant
Axis Clinical Trials /Los Angeles, CA./Oct. 2006 - Jan. 2007

Study Support and Coordination:

 Assisted the Primary CRC with study recruitment, patient enrollment, and tracking on high-enrolling studies.
 Assisted with study visits by performing consenting and study-related clinical procedures (participant education, vitals, EKGs,
phlebotomy/biospecimen processing/shipping, drug accountability/dispensing, and counseling participants).
 Led junior research assistants for a high-volume study with 465 screened participants and 208 randomized in a 2-year-long
weight loss study.

Reporting and Documentation:

 Ensured study-related reports and patient results were reviewed in a timely manner by the Research Coordinator and/or
investigator.
 Assisted the CRC with updating and maintaining logs.
 Prepared all source documents and lab kits prior to study visits.

Inventory Management
 Proactively maintained study supply inventory.
 Ordered supplies as required for multiple projects.

Data Management
 Conducted data entry within 24-48 hours of study visit completion.
 Resolved queries related to data.
 CLAUDIA A. VERA
WORK EXPERIENCE
Research Trial Recruiter/Marketing
Axis Clinical Trials /Los Angeles, CA./Jul. 2006 -Oct 2006

Data Mining and Patient Identification

 Performed data mining tasks in multiple EMR partner systems.
 Identified potential patients based on trial inclusion/exclusion criteria and matched medical records with on-site or remote
EMR access.

Patient Pre-Screening and Eligibility Assessment:

 Created phone pre-screening scripts and marketing materials for media channels (radio, print, webpage).
 Prescreened potential clinical trial participants for multi-therapeutic trials through chart review, in-person, and phone
interactions.
 Captured and reported detailed medical history, medication lists, and assessed patient eligibility based on protocol inclusion
and exclusion criteria scripts.

Community Outreach:
 Assisted and supported community outreach efforts, including community events or onsite visits.
 Identified new potential community partner opportunities.

Ward Clerk Transcriber

Kaiser Permanente /Los Angeles, CA./Dec. 2001- Jan. 2004
Responsible for supporting and coordinating the administrative activities of the nursing unit. Assigned to cover multiple units as
a floating ward clerk, i.e., Telemetry, Med/Surg, NICU, CCU, ICU, Labor and Delivery, and Emergency room.
 Transcribed written physician orders into ordering system (ie., consults, dietary orders)
 Scheduled tests and coordinated patient care activities in collaboration with the RN and other departments to ensure timely and
appropriate action.
 In conjunction with Discharge Coordinator, organized transfers to skilled nursing facilities
 Called or faxed prescriptions to pharmacy
 Updated the unit’s white board
 Answered and appropriately routed internal and external telephone calls
Medical Assistant
Dr. Bruce Larson /Los Angeles, CA./ Jan 2001- Dec 2001
Provided routine clinical and administrative support to the provider in an outpatient clinic setting (Front office/Back office)

 Performed rooming and/or intake process, including vital signs, height, weight, and data related to patient's reason for visit,

medication history, and allergy history

 Assisted the provider as directed, during treatments, examinations, and procedures ( ie., thyroid biopsies)

 Ensured patient safety by following infection control protocols

 Assisted in patient education and provided resources to patients regarding endocrine conditions

 Coordinated appointments and scheduled procedures

 CLAUDIA A. VERA
WORK EXPERIENCE
Shift Supervisor
Kentucky Fried Chicken /Los Angeles, CA./Oct 1999 – May. 2000
Played a key role in the operation of restaurant, with accountability for directing the team and ensuring compliance with
company standards in all areas of daily operations.
 Training and motivating team members
 Delegated shift assignments
 Designed efficient work processes.
 Customer relations
 Financial accountability during shifts
 Ensured that the highest quality products and services were delivered.
 Supported team by beings hands on during busy shifts
 Inventory management

Shift Supervisor
Popeyes Fried Chicken /Los Angeles, CA./Oct. 1998 –Oct 1999
Played a key role in the operation of restaurant, with accountability for directing the team and ensuring compliance with
company standards in all areas of daily operations.
 Training and motivating team members
 Delegated shift assignments
 Designed efficient work processes.
 Customer relations
 Financial accountability during shifts
 Ensured that the highest quality products and services were delivered.
 Supported team by beings hands on during busy shifts
 Inventory management

SUMMARY OF TRIALS EXPERIENCE

 Cervical Disease
 Systemic Lupus Erythematosus  Bipolar Disorder  Uterine Fibroids
 Psoriatic Arthritis  Schizophrenia  Endometriosis
 Rheumatoid Arthritis  Major Depression Disorder  Contraceptives
 Ankle Sprains  PTSD  Nocturia
 Idiopathic
 Obesity Overactive Bladder
 Gastroparesis  Type II Diabetes Mellitus-Pediatric & Adult
 Hepatitis C  Hypertension- Pediatric & Adult
 HIV  Asthma  Onychomycosis
 Chlamydia  Influenza  Alopecia
 Gonorrhea  COPD  Pediatric Hair lice
REFERENCES AVAILABLE UPON REQUEST