Kristi Lakey

Screened patient records and physician referrals to identify candidates for research studies.
Monitored adverse events, ensuring pati

• Coordinated clinical trials for dermatological studies and treatments.
• Managed patient recruitment and informed consent processes for research participation.
• Collaborated with medical staff to ensure compliance with protocol guidelines.
• Organized and maintained accurate study documentation and regulatory files.
• Scheduled and conducted study visits, collecting data per research protocols.
• Facilitated communication between investigators, sponsors, and regulatory bodies.
• Trained new staff on clinical trial procedures and best practices in research compliance.
• Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
• 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 .
• Monitored patient safety during clinical trials according to established guidelines.
• Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
• Reviewed CRFs for completeness and accuracy before database entry.
• Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
• Kept patient care protocols and clinical trial operations in compliance.
• Conducted routine visits to research sites to ensure compliance with protocol requirements.
• Reviewed medical records for accuracy of source documentation prior to database lock.
• Collaborated with internal departments such as Regulatory Affairs and Data Management to ensure that all studies were conducted in accordance with ICH-GCP guidelines.
• Collected, processed and delivered specimens from trial participants.
• Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
• Developed and maintained accurate and timely study databases.
• Compiled trial related documents into a master file as required by sponsor or regulatory agency.
• Performed patient assessments, collected and analyzed data, and prepared reports.
• Gathered and reviewed study data.
• Coordinated investigator meetings, conference calls, and site initiation visits as needed.
• Monitored subject enrollment and tracked dropout details.
• Educated participants on studies and anticipated outcomes.
• Took vital signs and collected medical histories as part of study protocols.
• Conducted screening interviews to determine eligibility of possible subjects.
• Provided training to study staff on protocol requirements and GCP regulations.
• Monitored patient safety throughout study participation and reported adverse events.
• Provided guidance on Good Clinical Practice regulations and other applicable regulatory standards.
• Conducted quality assurance audits at research sites to ensure adherence to protocols, SOPs, regulations, guidelines.

• Collaborated with principal investigator to orchestrate trial activities aligned with research protocols.
• Adhered to data collection requirements outlined in operations manuals and case reports.
• Conducted screenings to select appropriate candidates from patient records for studies.
• Maintained thorough informed consent records consistently.
• Handled lab-related duties, including ECGs and vital measurements, proficiently.
• Promptly entered study data into EDC with precision.
• Engaged critical thinking to deconstruct issues and derive solutions efficiently.
• Cultivated effective team relationships while sustaining momentum in high-paced environments.

• Gathered and organized materials to support operations.
• Promptly and Correctly enter study data into various EDC systems
• Set up and Trained Subject's on E-dairy
• Performed Vitals and ECG's
• Maintained compliance with protocols covering patient care and clinical trial operations.
• Collected data and followed research protocols, operations manuals and case report form requirements.
• Followed informed consent processes and maintained records.
• Screened patient records, databases and physician referrals to identify prospective candidates for research studies.
• Coordinated clinical trials focused on disorders such as Child Obesity and Smoking Sensation
• Carried out day-day-day duties accurately and efficiently.
• Demonstrated respect, friendliness and willingness to help wherever needed.
• Quickly learned new skills and applied them to daily tasks, improving efficiency and productivity.

Conducted scheduling for patient visits and radiology exams, confirming appointments systematically.

Checked in patients and handled co-pay collections efficiently.

Delivered exam preparation guidelines to patients, ensuring readiness for procedures.

• Reviewed daily schedules to identify and correct scheduling discrepancies.
• Addressed patient questions, fostering a positive experience within the facility.
• Managed charge entries accurately while coordinating referrals to endocrinologists.
• Engaged with Employee Action Group and served on Patient Family Advisory Council.
• Oversaw medication check-out processes, adhering to safety standards.

Scheduling patients for radiology exams, checking in patients, working with prior auth team, quoting prices, sending reports to referring physicians, collecting co-pays, relaying exam preps, giving directions, making sure orders have been received for exams, making outbound calls for scheduling, scheduling exams while working within the radiologist schedules, and answering any questions the patients might have.