Linda Aceto
Oviedo,FL
Summary
Bringing 20 years of comprehensive experience across clinical research and healthcare, including expertise in clinical trials, laboratory operations, patient care, phlebotomy, vital signs monitoring, GCP compliance, EKGs, injections, medical records management, scheduling, FDA regulations, medical imaging, anatomy, EMR systems, hospital settings, pulmonary function testing (PFT), HIPAA compliance, patient recruitment, medical terminology, nursing, and triage.
Overview
42
42
years of professional experience
Work History
Clinical Research Coordinator
Florida Institute of Clinical Research
09.2022 - Current
- Oversee and coordinate all aspects of clinical study conduct to ensure protocol adherence, regulatory compliance, and alignment with project timelines.
- Monitor study milestones, proactively identify potential delays, and implement corrective actions to maintain project schedule.
- Serve as a liaison between sponsors, investigators, monitors, and study staff to facilitate smooth trial execution.
- Ensure regulatory binders, source documents, and case report forms (CRFs) are accurate, complete, and audit-ready at all times.
- Assist with screening, enrolling, and following study participants, while promoting a positive experience to enhance retention.
- Accurately measure and document blood pressure, pulse, heart rate, temperature, and oxygen saturation levels.
- Conduct electrocardiograms (ECGs) according to study protocol and ensure proper documentation and upload.
- Draw blood and collect other biological samples per protocol; ensure proper labeling, handling, and shipping/storage procedures.
- Administer and interpret PFTs following study-specific guidelines.
- Connect devices to subjects, instruct on use, and retrieve and download data.
- Set up CGM devices, monitor functioning, and download data for analysis.
- Prepare digital diary platforms for subjects; provide training and support to ensure accurate use.
- Collect physical diaries from subjects and review for completeness and compliance with protocol.
- Accurately prepare and distribute oral or injectable investigational products in compliance with protocol and GCP.
- Perform injections (e.g., subcutaneous, intramuscular) as required by the study protocol and within scope of licensure.
- Perform tasks associated with the research coordinator company job description.
- 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.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Developed strong relationships with trial sponsors, ensuring ongoing collaboration and future project opportunities.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Streamlined patient visit schedules, reducing wait times and increasing patient satisfaction.
Clinical Research Coordinator
In-Quest Medical Research
03.2011 - 08.2022
- Reviewed clinical study protocols, informed consent forms, HIPAA authorizations.
- Led communication on behalf of the site with sponsors/CROs and investigators.
- Maintained and updated eTMF (Veeva Vault).
- Maintained and managed site level regulatory compliance with IRB and oversight stakeholders.
- Ensured federal and state regulations/guidelines and business SOP compliance and resolved site level protocol deviations.
- Scheduled visits to screen potential subjects according to protocol specific I/E criteria.
- Conducted, monitored, and coordinated study visits and developed study-specific eCRF.
- Performed data entry & quality control of documents in CTMS (Real Time) and resolved queries.
- Managed logistics for lab kits, study supplies, and IMP: processing and requesting orders, receipt, storage, quarantine, reconciliation and returns; Maintain temperature logs, excursions.
Clinical Research Coordinator
Partners In Clinical Research
10.2007 - 03.2011
- Perform EKG's
- Taking vital signs Professional Experience:
- Performing phlebotomy
- Processing blood and urine samples and packing them to be shipped.
- Reviewing medical history and medication.
- Evaluating the patient
- Performing protocol specific procedures.
- Dispense study medication with instructions.
- Completion of CRF pages, Regulatory Documents, Queries
- Completing serious adverse event reports.
- Retrieving medical records from hospitals and other physicians.
- Reordering and restocking medical supplies
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Developed strong relationships with trial sponsors, ensuring ongoing collaboration and future project opportunities.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Streamlined data collection processes for increased efficiency and accuracy in study results.
- Improved recruitment rates by developing and implementing effective patient outreach strategies.
Clinical Research Coordinator
DSI Renal Research INC
02.2007 - 09.2007
- Assist Medical Directors in Clinical Trials participation.
- Train staff in clinical research procedures.
- Complete regulatory documents
Clinical Research Coordinator
Hypertension & Nephrology Inc
08.2001 - 02.2007
- Assist Medical Directors in participating in clinical trials.
- Training staff in conducting clinical trials.
- Assist sites in completing regulatory documents.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Developed strong relationships with trial sponsors, ensuring ongoing collaboration and future project opportunities.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Streamlined data collection processes for increased efficiency and accuracy in study results.
- Improved recruitment rates by developing and implementing effective patient outreach strategies.
- Conducted comprehensive reviews of clinical trial protocols to identify and rectify potential issues before study initiation.
CNA/Medication Technician
Kent Regency Genesis Eldercare
11.1983 - 08.2001
- Interact closely with Registered Nurses to assure quality patient care on Sub acute unit.
- Responsibilities include performing patient assessments, assisting patients with all ADL's while assessing their physical and emotional well-being.
- Monitoring vital signs and assisting the physical therapists with exercise and ambulation
- Applying sterile dressings for wound care.
- Accurately distribute all medications on the sub-acute unit.
- Answered call lights and supported patient comfort and safety by adjusting bed rails and equipment.
- Evaluated patients to identify and address wounds, behavioral concerns, and medically relevant symptoms.
- Supported ambulation and physical therapy needs by conducting planned exercise routines.
- Completed activities of daily living for patients unable to self-care, and assisted those with limited mobility in completing tasks.
- Responded to patient requests for supplies and personal comfort items such as extra blankets.
- Prepared medication doses accurately by following medication administration record (MAR) written by healthcare providers
- Checked patient vitals such as temperature, blood pressure, and blood sugar levels.
- Promoted good oral and personal hygiene by aiding patients with shaving, bathing, and teeth brushing.
- Enhanced patient satisfaction by providing compassionate and attentive care.
- Maintained confidentiality of patient information according to HIPAA guidelines while communicating effectively with team members about critical updates.
- Utilized proper body mechanics and assistance devices when transferring patients, minimizing the risk of injury for both parties.
- Ensured prompt response to call lights, addressing patient needs in a timely manner.
- Assisted with feeding and monitored intake to help patients achieve nutritional objectives.
- Prevented bedsores by regularly repositioning patients and implementing proper wound care techniques.
- Delivered individualized patient care by recording vital signs, documenting observations, administering treatments, and evaluating patient needs.
Home Health Aide
Assisted Daily Living
01.1994 - 01.1995
- Provide care for patients in their home environment.
- Responsibilities include assisting patients with all ADL's while assessing their physical and emotional well-being.
- Monitoring the home for safety and reported any abnormalities to the Case Manager.
- 8 hrs per week
Phlebotomist
The Miriam Hospital
01.1987 - 01.1989
- Responsible for drawing blood on the majority of hospital patients diagnosed with varying medical conditions.
- Maintain all necessary precautions when drawing from patients with contagious conditions.
- Centrifuged blood samples as outlined in clinical protocols.
- Completed proper sanitation and cleaning of equipment and work areas between patients.
- Reduced contamination risks by strictly adhering to infection control protocols and maintaining a clean work environment.
- Tracked collected specimens by initialing, dating, and noting times of collection.
- Stocked phlebotomy cart or carrier with appropriate supplies.
- Demonstrated adaptability by effectively performing blood draws on diverse patient populations, including pediatric, geriatric, and challenging cases.
- Established and maintained positive working relationships with patients, staff and clinical personnel to build trust and camaraderie.
Education
Certified Medical Assistant -
St. Augustine School of Medicine
01.2018
Diploma -
Warwick Vets Memorial High School
Warwick, RI1987
Administration Certificate -
University of Rhode Island College of Pharmacy
05.1987
Certified Phlebotomist -
Rhode Island Institute of Providence
Providence, RI01.1987
Certified Nursing Assistant -
Kent Nursing Home
1987
Timeline
Clinical Research Coordinator
Florida Institute of Clinical Research
09.2022 - Current
Clinical Research Coordinator
In-Quest Medical Research
03.2011 - 08.2022
Clinical Research Coordinator
Partners In Clinical Research
10.2007 - 03.2011
Clinical Research Coordinator
DSI Renal Research INC
02.2007 - 09.2007
Clinical Research Coordinator
Hypertension & Nephrology Inc
08.2001 - 02.2007
Home Health Aide
Assisted Daily Living
01.1994 - 01.1995
Phlebotomist
The Miriam Hospital
01.1987 - 01.1989
CNA/Medication Technician
Kent Regency Genesis Eldercare
11.1983 - 08.2001
Certified Medical Assistant -
St. Augustine School of Medicine
Diploma -
Warwick Vets Memorial High School
Administration Certificate -
University of Rhode Island College of Pharmacy
Certified Phlebotomist -
Rhode Island Institute of Providence
Certified Nursing Assistant -
Kent Nursing Home
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