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MARISOL PEREZ

Temecula, CA ad408p@r.postjobfree.com 760-***-**** linkedin.com/in/marisol-perez-892770265 P R O F E S S I O N A L S U M M A R Y

Accomplished adaptable Research Professional with extensive experience in Clinical Trials, Phases I-IV. Adept at supporting the administration and progress of clinical trials under the guidance of the study team including trial administrative functions to ensure relevant process are performed in accordance with the Code of Federal Regulations (CFR) of the Food and Drug Administration (FDA) and the International Conference on Harmonization/Good Clinical Practice (ICH-GCP). Passionate about collaboration and development of projects assigned to achieve corporate goals and mission. SKILLS

Cross Functional Effective Time Management Detail Oriented Collaborative Flexible Team Player Communicative Results Oriented Organizational Skills eTMF and CTMS Systems (Veeva Vault Clinical/Phlex TMF) IWRS Systems (Endpoint IRT) MS Office Adobe Acrobat Database Programs Regulations and Regulatory Guidance

E X P E R I E N C E

Clinical Trial Associate/In-House CRA 1 June 2023-Present Catalyst, on assignment with Eisai, Inc (Oncology)

● In collaboration with eTMF operations team, maintains trial master file (TMF) and study documentation in accordance with regulatory requirements and internal SOP’s.

● Reviews study, country, and site documents for completeness and accuracy for inclusion in the TMF systems.

● Supports study teams with review of eTMF to always ensure inspection readiness.

● Tracks study specific monitoring reports and files to the TMF system as required per study.

● Tracks SOP packages from project teams to support site activation and the initiation of investigational product shipment.

● Supports QC of TMF systems and familiar with data review experience.

● Supports study teams with gap analysis of the ISF among other activities for Inspection Readiness.

● Knowledge of relevant operational procedures, systems and Demonstrated experience with Office 365 and Office products (specifically Excel based tracking tools)

● Keeps up to date with all the changes/required knowledge on ICH GCP, written standards and attends appropriate training.

● Knowledge of quality guidelines that govern clinical studies.

● Evolving individual with the ability to work independently, as well as in a team setting and oversee clinical study tracking systems.

● Proactively identifies issues and raises them to the Study Lead or manager for necessary corrective action.

● Experience with the use of portal-based systems to support day to day clinical operations including clinical trial management systems, SharePoint, Veeva Vault, Phlex, Passport, Learning Management System among others. Clinical Trial Assistant (Oncology/Pain Management) May 2019 – December 2022 Heron Therapeutics Inc., San Diego, CA

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Collaborated with cross function teams and Study Managers to support trial site identification and study initiation including study start-up activities, tracking of study metrics, feasibility data, Informed Consent Document review, essential document collection and review of Trial Master File (TMF).

● Supported study teams by preparing initial study document packages including templates provided to study sites (Form FDA 1572, Financial Disclosure Forms, Enrollment logs, Instructions for use and storing of devices such as iPads, among others)

● Supported Oncology and Pain Management study teams with collection and review of essential documents and eTMF filing.

● Prepared Site Activation Packets to ensure essential documents are accurate in preparation for Clinical Trial Material Shipment and site activation.

● Tracked study site progress leading up to activation and provides reports to the study team.

● Liaises with Lead CRA/CRA on planned SIV date to prepare and customize Study Binders (Site Investigator File and Pharmacy Binders) both electronic and paper version.

● Established relationships with key vendors as delegated by Study Lead.

● Maintained communication with investigative sites regularly for status updates, study communications, reminders and provided support as needed.

● Liaises with key Central IRB contacts and prepared IRB applications on behalf of the study team including Amendments, Annual Reviews, Subject Recruitment Materials, and other study related advertisement documents.

● Participated in team study meetings, including agenda preparation, noted meeting minutes, documented study team actions, decisions, and tracked until final resolution.

● Utilizes clinical trial databases (e.g., EDC, CTMS, eTMF) and Interactive Web Response Systems (e.g., IWRS), including support of user access management and generation of key reports.

● Supported study teams by tracking patient enrollment (average of 3-4 studies across 25+ sites for fast paced enrollment up to 6 months) and provided reports to the Study Manager and team.

● Updated Clinical Study Team with updates of clinical systems and processes to track site compliance and performance to meet project timelines.

● Collected completed training records and other trial materials throughout and at the end of the study.

● Assisted in the preparation and distribution of newsletters and study memorandums.

● Assisted with periodic review of the Trial Master File for completeness.

● Assisted Clinical Research Associates during site visits to ensure compliance with Investigator Site File (ISF) review and miscellaneous tasks as needed.

Senior Clinical Research Coordinator/Regulatory Specialist Nov 2017 – 28 May 2019 IQVIA, San Diego, CA

● Management and maintenance of Trial Master Files for an average of 15-25 studies.

● Responsible for completion of essential documents and IRB submissions.

● Participated in site selection, site initiation, routine monitoring visits, audits, Investigator meetings and site closure visits.

● Planned and coordinated the initiation of clinical research trials following ICH/GCP, FDA, HIPPA, OSHA guidelines and regulations.

● Lead Research Coordinator responsible for satellite locations including training of office staff and day-to-day activities.

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● Served as the primary point of contact for Sponsor audits.

● Recruited and provided support to a new model implemented by IQVIA in collaboration with Clinical Trial Educator to increase participant enrollment.

● Traveling Study Coordinator throughout various locations in San Diego, CA.

● Participated in site selection, site initiation, routine monitoring visits, audits, Investigator meetings and site closure visits.

● Served as the primary point of contact for Sponsor audits.

● Ensured Adverse Events (AEs), Serious Adverse Events (SAEs), and trial related endpoints were appropriately reported as required by GCP, protocol, IRB/IRC, and/or sponsor.

● Oversaw the management and accountability of Investigational Products (IP) including proper storing, dispensing, destruction, randomization codes and procedures for breaking codes.

● Created adequate and accurate source documents for the study.

● Ensured trial data is accurate, complete, and verifiable from source documents in accordance with ALCOA.

● Utilized portals to track, maintain and upload essential documents.

● Utilized Electronic Data Capture (EDC) Systems and Interactive Web Response Systems (IWRS

● Attended weekly internal meetings, took meeting minutes, and provided weekly updates of study related activities.

● Completed phlebotomy tasks including collection of Pharmacokinetic, Pharmacogenetics and Pharmacogenomics samples.

● Prepared and shipped hazardous materials, (IATA Certified) Completed vital signs measurements including detailed blood pressure measurements and Ambulatory Blood Pressure Monitoring.

Local IRC Regulatory Assistant Jul 2015-May 2016

Palomar Pomerado Hospital Local Institutional Review Committee, Poway CA

● Provided general support and oversight in partnership with the IRC Administrator in managing study sites.

● Provided support to the IRC committee to ensure study sites are following policies, procedures, and practices to protect the rights of human research participants.

● Initiated and prepared regulatory documents and submissions.

● Conducted essential document collection, review, maintenance, and study close out activities.

● Attended Institutional Review Committee meetings and teleconferences.

● Created and distributed meeting agendas, meeting minutes, documented study actions, decisions, and tracked until final resolution.

● Ensured sites are following protocol, amendments, Good Clinical Practice, FDA regulations and other applicable Regulatory requirements.

● Ensured credentialing of individuals delegated to the trial to document the staff are qualified to perform trial related duties.

● Ensured study sites training and certifications are updated and filed in TMF.

● Served as an information resource to site staff, investigators, and vendors (including agencies) on questions involving policies, procedures, and protocol review.

● Facilitated and assisted new Investigators on proper Good Clinical Practice training prior to research project involvement.

● Assisted new study sites and investigators with IRB applications and submissions. MARISOL PEREZ

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● Maintained knowledge of the regulations and regulatory guidance, and expertise in the review of human participants.

Regulatory Specialist/Clinical Research Coordinator 2006-November 2017 Arch Health Medical Group, Poway CA

(San Diego Managed Care Group acquired by Arch Health Medical Group 2012)

● Maintained Trial Master Files for an average of 15-25 studies including start up, maintenance and closing.

● Assisted with study protocol feasibility/site questionnaires to ensure the site has resources and adequate qualifications to conduct the clinical trial.

● Prepared regulatory packets and submitted to study sponsors and Central IRBs in preparation for site activation.

● Conducted essential documents training of clinical research personnel.

● Participated in site selection, site initiation, routine monitoring visits, audits, Investigator Meetings, and site closure visits.

● Served as the primary point of contact for Sponsor audits.

● Planned and coordinated the initiation of assigned research projects.

● Ensured the sites are following protocol, amendments (if applicable) GCP, and other applicable Regulatory requirements.

● Ensured credentialing for individuals delegated to the trial to document the staff are qualified to perform trial related duties.

● Implemented tracking procedures to ensure sponsor/protocol required training and certifications are updated and filed in TMF.

● Prepared, submitted, tracked, and maintained correspondence and submissions with Central IRB/IEC and Local IRC including changes to site staff, location, change of Investigator, and any other relevant site changes.

● Conducted internal data monitoring to assess the progress of the clinical trial and communicated deviations from the protocol, Standard Operating Procedures, Good Clinical Practice or other applicable requirements to the investigator, trial staff and documents appropriate action taken to secure compliance and to prevent reoccurrence of the deviation.

E D U C A T I O N & C E R T I F I C A T I O N S

Clinical Trials Design and Management Program/San Diego, CA 2022-Present University of California, San Diego

Radiology Technician/Poway, CA

Radiology Program certificate

2002

Registered Medical Assistant/Poway, CA

2001

Registered Medical Assistant Certificate

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