Stephanie Rivera Email & Phone Number

San Juan, Puerto Rico

Guaynabo, Pr

I lead the execution of clinical trials, ensuring smooth operations and high-quality results. Engaging with research participants, I address concerns and provide crucial study information. I mentor and guide research staff to enhance their capabilities. I streamline central IRB document submissions and edits upon Sponsor Request. My responsibilities include collecting, coding, and deciphering research data, and ensuring data quality on EDC & CTMS. I ensure adherence to research regulatory and ethical standards, collaborating with laboratories to discuss findings.Highlights of my achievements:• Achieved the top enroller position at the site for the Registry of Asthma Patients Initiating Dupixent (Sponsor: Regeneron) by efficiently reviewing patient charts on the EMR for recruitment purposes.• Demonstrated proficiency in creating source documentation from protocols(eCRF), managing document revisions, and controlling by FDA guidelines.• Obtained streamlined management of budgetary and contractual aspects for clinical sites, ensuring optimal resource allocation and financial efficiency.• Directed the successful submission of regulatory documents for study start-up, notably Form FDA 1572, ensuring compliance and expeditious commencement of research initiatives.• Managed and addressed CAPA reports for prompt resolution, maintaining the quality and integrity of research activities.• Enhanced communication of study objectives to participants in the Investigational New Drug (IND) process, fostering understanding and cooperation.• Engaged with subjects, actively addressing, and understanding concerns, enhancing participant satisfaction and cooperation in research endeavors.• Yielded valuable insights and significant contributions by coordinating and managing research studies in respiratory therapeutic areas.• Successfully resolved complex challenges with a proactive and solution-oriented approach, ensuring the timely and successful completion of research projects.

San Juan, Puerto Rico

I spearheaded the coordination of clinical trials at the Advance Medical Research Center, overseeing efficient budget management and seamless study initiation. I skillfully gathered data, conveyed study objectives to participants, administered questionnaires, and ensured the successful commencement and conclusion of research. Leveraging virtual platforms for outreach and healthcare provider relationships for referrals, I optimized screening processes for efficiency.Highlights of my achievements:• Successfully contributed to the understanding and management of COVID-19 by coordinating the Phase 2/3 study PF 07321331/Ritonavir for Pfizer.• Steered a multidisciplinary team, including medical doctors, clinical study coordinators, nurses, data analysts, pharmacists, and sponsor administrators, in overcoming challenges during a global pandemic.• Innovatively addressed rapid recruitment and screening obstacles, implementing virtual platforms for outreach, leveraging healthcare provider relationships for referrals, and optimizing screening processes for efficiency.• Successfully coordinated and managed the Phase 2/3 study PF 07321331/Ritonavir, sponsored by Pfizer, comparing effects to placebo in non-hospitalized symptomatic adults with low risk of progressing severe illness due to COVID-19.• Overcame the significant challenge of rapid recruitment and screening by organizing a task force within the team and implementing innovative recruitment strategies.• Partnered with data analysts and research assistants to perform daily data entry for all patients, enriching the comprehension and management of COVID-19.• Made a significant contribution to the understanding and management of COVID-19 through dedicated efforts in daily data entry and collaborative teamwork.• Demonstrated the power of effective teamwork during a crisis by actively engaging with colleagues, reinforcing the importance of adaptability, collaboration, and clear communication.

Guaynabo, Pr

I personally mentored high school students (10th, 11th, and 12th grade) in Biotechnology and Marine Biology, stressing the significance and practical application of laboratory techniques. I aimed to inspire the next wave of scientists by cultivating an engaging learning atmosphere, crafting compelling lectures, and incorporating hands-on learning tools. Highlights of my achievements:• Elevated student engagement and comprehension in technology-based classroom settings by developing impactful lectures and hands-on learning tools across diverse subjects including Chemistry, Biotechnology, Laboratory Techniques, Environmental Sciences, and Marine Biology.

Bayamon, Pr

In my role as a Laboratory Technician at Environmental Quality Laboratories, Inc., I contributed significantly by conducting microbiology analyses on water and air samples. My expertise lies in the identification of microorganisms, adhering to regulations set forth by State and Federal Government Agencies, with a specific emphasis on assessing environmental impact.Highlights of my achievements:• Ensured audit readiness and compliance with standard operating procedures (SOPs) in the laboratory, resulting in seamless external project collaboration with the EPA and local regulatory authorities.• Achieved enhanced testing and quality control outcomes through meticulous maintenance of lab equipment and adherence to SOPs.• Improved efficiency and organization by implementing a comprehensive laboratory inventory system.• Elevated workplace hygiene and safety by consistently sanitizing working areas.• Streamlined procedures for preparing culture media, contributing to overall lab effectiveness.• Employed a "Log Book" and materials management system to further optimize record-keeping and resource utilization in the laboratory.

Master Of Science - Ms, Pharmaceutical Sciences

Bachelor'S Degree, Major: Bs-Microbiology | Credits Earned: Semester Hours

• Successfully developed the natural product "Natu Sinus Relief," an innovative treatment for Sinusitis, following comprehensive research.