MARIA LOURDES BARTOLOME

Clinical Research Coordinator

MD Medical Research

01.2007 - Current

Performed protocol-related tests and activities, conducted study participant visits, entered subject data in Electronic Data Capture System, processed and shipped laboratory specimen.
Participated in Phase II, III, and IV clinical trials in the following therapeutic areas: T2DM, Hypertension, Dyslipidemia, Cardiovascular, CKD, Anemia, Gout, Eye Study, Osteoarthritis, Rheumatoid Arthritis, Osteoporosis, Flu, Alzheimer's Study, Lyme Disease, Asthma, and COPD.
Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
Gathered, processed, and shipped lab specimens.
Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
Followed informed consent processes and maintained records.
Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
Worked with Principal Investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
Monitored patient safety throughout clinical trials and reported any adverse events.
Contributed to the successful completion of clinical trials by proactively resolving issues, mitigating risks, and meeting deadlines in a fast-paced environment.
Prepared detailed informed consent documents to clearly communicate risks, benefits, expectations, rights and responsibilities related to participation in clinical trials.
Maintained compliance with regulatory guidelines through rigorous documentation and protocol adherence.
Streamlined data collection processes for increased efficiency and accuracy in study results.
Complied with research protocols by providing ongoing quality control audits.
Collected data and followed research protocols, operations manuals, and case report form requirements.
Oversee the management of investigational product supplies, ensuring appropriate storage conditions were maintained at all times for optimal efficacy during trials.