Data Entry Clinical Research

Valerie Martinez, Senior Clinical Research Associate II (Regionally Based)USA

Charlotte,North Carolina Phone:704-***-****: Email: ******************@*******.*** A therapeutics performing provide Senior leadership, Clinical tasks clinical Research as training, an trials Unblinded and Associate and multiple mentorship and (CRA) Blinded projects. with to CRA. over Familiar fellow Able 10 clinical year’s to with identify, working extensive research investigate, remotely experience associate and and across coordinate successfully various as well as Skills & Abilities

Management

Ability and desire to work in a team environment Training and Mentoring Documentation and Submission Communication Skills Compliance & Procedure Site Management

Ensure the Safety of the Subject Detail Oriented

Communication

Maintain and/or information a very high on level client of Professionalism products. when assisting customers with any type issue or feedback THERAPEUTIC EXPERIENCE- PHASE II, III &IV

Endocrinology(Constipation(Therapy) Rheumatology(Ophthalmology(CNS(Bipolar Pulmonary/Disorder adults) Pain Diabetes Diabetic Management: Cardiovascular(Respiratory(and Mellitus Retinopathy) Autism(Type Osteoarthritis child) Allergy/Hypertension, Oncology(I &vaccine II) Asthma, Gastrointestinal(Lymphoma and COPD Hyperlipidemia) Arthritis) & Upper and Dyspepsia, Dermatology(Leukemia) Respiratory Women Irritable Wound Infection Health(Infection) Bowel Care(Hormone Site Syndrome Ulcers) Reaction) Replacement and Phase I Number of Studies: 5+

Phase IIA/IIB Number of Studies: 6+

Phase III Number of Studies: 30+

Phase IV Number of Studies: 2

Experience:

Covance Inc, Durham, North Carolina/USA -Nov 2020 – April 2022 Senior Clinical Research Associate II

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•Responsible for all aspects of site management as prescribed in the project plans.

•Responsible sites, duties, maintenance as assigned. For all of aspects study files, of study conduct site of monitoring, pre study and including initiation routine visits; monitoring liaise with and vendors; close out and of other clinical

•General on site monitoring responsibilities:

safely •Ensuring enter the patients study into staff the who study. will conduct the protocol has received the proper material and instructions to protocol •Ensure requirements the protection are of adhered the study to patients according by to verifying the application that informed regulatory consent requirement. process procedures and carefully •Ensure sourced the integrity document of the review. data submitted on the case report forms or other data collection tools by

•Monitoring data for missing or implausible data.

task expenses •Ensure in an in effective the a Economical resource manner. of the fashion, according Sponsor according and to SOPs Covance to and Covance established are spent travel wisely policy. guidelines, by performing including the managing required travel monitoring

•Ensuring audit readiness at the site level.

•Travel, including air travel, may be required and is essential function of the job.

•Preparing adequate and timely trip reports.

•Manage small projects under direction of a Project Manger /Director as assigned. report •Serves and as review a lead as monitor assigned. for protocol or projects and may assist in establishing monitoring plans and trip

•Review progress of projects and initiate appropriate action to achieve target objective.

•Organize and make presentations during monthly team meetings.

•Interact with internal work group to evaluate needs, resource and timelines.

•Track and follow up on Serious adverse events reporting and Process production of the report narrative.

•Assist with training, mentoring and development of new employees. Co- monitoring.

•Ensuring audit readiness at the site level.

IQVIA, Raleigh, North Carolina/USA Oct 2019 – Aug 2020 Senior Clinical Research Associate I

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Visiting guidelines •Previously included and performed other monitoring as applications routine. of the Site informed regulatory visits, consent including requirement. procedures.pre-study,, initiation, compliance interim, with the and protocol, closeout GCP/visits. ICH medication informed •Conduct consent logs, remote adverse forms review and event of various source logs, regulatory protocol documents, deviation documents. regulatory logs, documents enrollment transmitted logs, drug accountability by the site. Con- logs,

•Kept track and resolve data entry queries during data analyst and as needed in between monitoring.

•Ensure audit readiness at the site level.

•Prepare adequate and timely trip reports.

investigators. from • Perform previous other Sites monitoring duties to discuss that visit. are Items signed including by manager data entries conduct SAE’s weekly enrollments, and biweekly and any monitoring outstanding calls items with ICON CLINICAL RESEARCH ~07/2014 – 07/2019 ~ North Wales, PA Senior Clinical Research Associate I

Monitoring responsibilities include:

•Perform routine site visits, including pre-study, initiation, interim, and closeout visits. Guidelines •Visits to and include other monitoring applicable of regulatory proper informed requirements consent and procedures, assurance compliance of good site with performance. protocol, GCP/ICH disposition •This is accomplished and accountability, by detailed site personnel review of subject and procedures. records, essential documents, investigational product

•Track and follow up on Serious adverse events reporting and Process production of the report narrative. duties. •Ensure all staff that will be conducting the trial is training and are delegated to preform the required

•Ensure the safety of the patients participating in the trial. ICON CLINICAL RESEARCH~07/2013 – 07/2014 ~ NORTH WALES, PA Clinical Research Associate II

assigned •Provided protocol(monitoring, s) as a lead planning, member organization, of the team. communication, and implementation of study objectives for applicable •Performed regulations. management of study site activities to ensure the integrity of clinical data, in adherence to all Procedures •Good Clinical (PSOPs)Practices, . Standard Operating Procedures (SOPs), and Project Specific Operating 4

coordinating lead. •Assumed all the monitoring role of a Lead activities, CRA on and projects communicating by providing the status direction of these and guidance activities to to project the study team, Project

• Ensure all drug accountability during each on-site monitor visit.

• Ensure all SAEs are reported as pre protocol during each on site visit as well as weekly contact to site. Education

2005 License Practical Nurse

PROFESSIONAL MEMBERSHIPS

2011 DIA

2012 Association of Clinical Research Professionals 2002 Association of licenses practical Nurses

REFERENCES AVAILABLE UPON REQUEST

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