Clinical Research Data Management

JEANETTE DE LEON

**** ***** ** *********, **, ***43 407-***-**** ******.**********@*****.***

PROFESIONAL SUMMARY

A highly organized and detail-oriented clinical research professional with over 10 years of experience in managing and supporting clinical trials. Skilled in overseeing various aspects of clinical research, including patient enrollment, informed consent processes, biospecimen collection, and data management. Strong background in administrative support and patient coordination, with a commitment to adhering to protocol and local regulations. EXPERIENCE

Associate Clinical Research Manager

ThermoFisher – Orlando, FL Dec 2023 - Present

• Manage various aspects of clinical trials encompassing diverse subject populations, both healthy and unhealthy, across inpatient and outpatient settings

• Conduct outpatient visits, proficiently executing the informed consent process and ensuring compliance with regulatory guidelines

• Demonstrate excellence in coordinating biospecimen collection and maintaining patient charts and data records.

• Facilitate seamless communication between sponsors, investigators, and the research team, ensuring alignment with study objectives and timelines

• Provide support for study execution, communicating directly with study monitors and fostering positive relationships with study participants

• Oversee critical data management tasks, including meticulous data entry, comprehensive source data verification, and proficient resolution of queries

• Ensure the accuracy and integrity of electronic data capture (EDC) systems and laboratory data, while meticulously reviewing subject eligibility statutes and promptly notifying stakeholders as needed Research Associate

ThermoFisher – Orlando, FL Jul 2022 – Dec 2023

• Completed administrative functions on assigned trials.

• Prepared and ensured all relevant patient files were ready ahead of the visits as per protocol and local regulations

• Assisted with photocopying, faxing, and filing source documentation

• Contacted medical offices to request medical records

• Scheduled patients for follow-up visits, external appointments, transport, etc.

• Conducted reminder telephone calls to patients to confirm visits

• Assisted Investigators and CRC with chart requests as well as other duties as requested Clinical Research Coordinator

Accel Clinical Research – Deland, FL Nov 2019 – Jun 2022

• Worked directly with the patient/subject interface at the research site to lab sample delivery

• Attended and participated in Investigator meetings, monitoring visits, audits, and seminars

• Assisted with pre-screening and enrollment of subject into studies

• Supported subjects on trial to ensure a positive patient experience

• Assisted Investigators with recording and reporting Adverse Event and SAE as per local regulatory guidelines

• Documented in source and completed data entry

Medical Assistant / Research Assistant

Pediatric Neurology, P.A. – Orlando, FL Feb 2014 – Jun 2018

• Maintained accurate records of patient care, progress, and concerns

• Monitored vital signs, such blood pressure and pulse

• Obtained medication history

• Performed phlebotomy techniques and ECG on children 2 months and older

• Assisted research team with research study related tasks (Regulatory filing, Processing of lab samples, maintaining subject binders, assisting with subject visits, etc.)

• Assisted EEG Tech with performing photic and hyperventilation portion of EEG’s as well as monitoring video monitors and reporting any seizure activity to EEG Tech's EDUCATION

Medical Assistant Certificate

Anthem College, Orlando, FL, US Jul 2000

Bachelor’s degree in arts – Secretarial studies

Bayamon Central University – Bayamon, Puerto Rico, US Aug 1993 ADDITIONAL RELEVANT EXPERIENCE

• Phlebotomy and dosing

• eCRF Applications (Veeva Vault, Medidata, Oracle)

• CTMS system (Clinical Conductor)

• Microsoft Office Applications (Excel, Word, Outlook, Teams, PowerPoint, SharePoint)

• Electronic Health Record System (Cerner)

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