Daniela Pargas

Clinical Research Coordinator

Southwest General Healthcare Center

Fort Myers, FL

08.2022 - Current

Preparations of IRB Applications, Including Protocols and Inform Consents, as well as obtaining approval to conduct clinical trial.
Creating sources to document procedures for each clinical trial.
Developed and maintained accurate and timely study databases.
Maintain appropriate correspondence with the IRB, including adverse events, annual renewals and protocol amendments.
Performed patient assessments, collected data.
Educate participants on studies and anticipated outcomes.
Took vital signs and collected medical histories as part of study protocols.
Responsible for clinical tasks including venipuncture, IV placement, vital signs, body measurements, ECG, Fibroscan.
Performing Spirometries and Spirometer Calibration.
Collect, process and shipment of samples obtained from subjects as part of clinical trials.
Conducting MMTT and OGTT test.
Collected, processed and delivered specimens from trial participants.
Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
Kept patient care protocols and clinical trial operations in compliance.
Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, lab results .
Keep Regulatory documentation for clinical trials up to date.
Placing, Monitoring and downloading Data from Medical Devices as Glucometers, Thermometers, CGMs, Holter Monitors...
Develope case report forms for data collection at investigational sites.
Working with contracts and budgets with study Sponsors from study start-up through study close-out.
Communication with Sponsor, CRAs and any other member conducting trial to coordinate monitoring visits, as well as facilitate all the information required by them prior, during, and after visits.
Entering Data into the Electronic Data Capture System and Queries resolve.
IP Preparation and Subject Dosing for Clinical Trials that does not required a Licensed Pharmacist.
Providing and Reviewing Data on Subjects Diaries.
Scheduling appointments with Third Parties for procedures to be performed out of institution.
Addressing and Assuring Subjects compliance.