Melissa Horn
Lago Vista
Summary
Experienced with coordinating clinical trials and managing study logistics. Utilizes comprehensive knowledge of research protocols to ensure compliance and accuracy. Track record of fostering effective team collaboration and maintaining precise documentation throughout research process.
Results-driven research professional prepared for challenges of overseeing clinical studies. Proven track record of managing complex projects and ensuring compliance with research protocols. Known for fostering team collaboration and adapting to evolving project needs, while excelling in data management and regulatory adherence.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
Texas Diabetes and Endocrinology
06.2015 - 02.2017
- Create source documents, attend Investigator meetings, site initiation, routine monitoring visits, recruit patients for studies, work with Principal Investigator to determine participant qualification according to protocol, prepare and organize materials for participant visits, obtain informed consent and continue ICF process, perform all procedures as required per protocol (height, weight, urine drug screens, breathalyzer, ECG's, vital signs, phlebotomy, utilize nursing assessment skills when collecting and documenting medical history, concomitant medications, and adverse events, administer study medication, schedule patient visits, drug accountability, processing and shipping of biologic specimens, as well as any other procedure required per protocol) ensure safety and welfare of participants, utilize clinical judgment to provide high standard of care for participants, review charts for accuracy and completeness, prepare charts for Physician review, maintain status of subjects in electronic database, assist with training of staff.
Screening Coordinator
Covance Inc
10.2009 - 04.2013
- Coordinate screening portion of clinical trials: work with Principal Investigator to determine participant qualification according to protocol, prepare and organize materials for participant screening and physical exams, obtain informed consent and continue ICF process, obtain medical history, perform all screening procedures as required per protocol (height, weight, urine drug screens, breathalyzer, ECG's, vital signs, phlebotomy, processing of biologic specimens, as well as any other procedure required per protocol) review screening charts for accuracy and completeness, prepare screening charts for Study Manager and Physician review, maintain status of subjects in electronic database, notify subjects regarding eligibility of participation, assist with training of staff.
- Research Nurse Study unit activities: ensure safety and welfare of participants, utilize clinical judgment to provide high standard of care for participants, utilize nursing assessment skills when collecting and documenting adverse events, perform study related activities per protocol, collect and process biological samples, record data obtained, quality control of study data.
Clinical Research Coordinator
Lovelace Scientific Resources
11.2007 - 10.2009
- Coordinating clinical trials: creating source documents, site initiation and qualification visits, determine participant qualification, obtain informed consent and continue ICF process, patient visits, administering study medication, phlebotomy, lab processing and shipping, scheduling patient visits, completing CRF's, recruiting patients for studies, drug accountability, adverse event assessment.
Admissions Coordinator
Hospice Austin
08.2004 - 03.2007
- Coordinating Hospice Austin admissions: Retrieve messages, Receive phone calls from families and referral sources, document all information obtained during phone call, triage calls, coordinate times for nurses and families meet, call or fax doctor's orders, order medication when necessary, order DME when needed, create charts for patients, enter patients data into computer, prepare paperwork for on call nurses, perform patient home visits when needed, cover shifts at hospice facility when needed, tend to anything else that may arise during the day.
Utilization Review Nurse
LK Jordon and Associates
11.2003 - 08.2004
- Determine payment authorization of medically appropriate, cost effective care through assessing the medical necessity of outpatient services. Evaluate appropriateness of the treatment utilizing the Texas Administrative Code, Texas Health and Human Services Commission, approved medical policy, and industry standards.
Clinical Research Coordinator
Radiant Research
11.2002 - 11.2003
- Coordinating pediatric clinical trials: creating source documents, attending investigator meetings, site initiation and qualification visits, determine participant qualification, obtain informed consent and continue ICF process, patient visits, administering topical, oral, IM, sub q medications, phlebotomy, lab processing, scheduling patient visits, collecting data, completing CRF's, completing monthly PI reviews, keeping in constant contact with principle investigator regarding all aspects of study, recruiting patients for studies, ensuring all studies are in compliance with GCP's.
Clinical Research Nurse/Coordinator
PPD Development
08.2001 - 10.2002
- Charge nurse for evening recovery care after oral surgery, Assessing pain, adverse events, and general well-being of patients. Assessing and administering pain medication as needed. Completing CRF's, reviewing charts. Providing direction for our technicians as to ensure protocol is being followed.
Office Nurse
Austin Endocrine Associates
07.2000 - 08.2001
- Responsible for checking in patients, calling in prescriptions, giving injections, phlebotomy, chart review, prior authorization and scheduling of medically necessary tests, assisting doctors with biopsies, patient education of possible medication side effects and self-administration of insulin, additional duties as assigned.
- LVN License Number: 175725
Education
LVN - LVN program
Western Texas College
Skills
- Good clinical practices
- Electronic data capture
- Documentation management
- Adverse event reporting
Certification
- LVN November 2016
- CPR June 2017
Timeline
Clinical Research Coordinator
Texas Diabetes and Endocrinology
06.2015 - 02.2017
Screening Coordinator
Covance Inc
10.2009 - 04.2013
Clinical Research Coordinator
Lovelace Scientific Resources
11.2007 - 10.2009
Admissions Coordinator
Hospice Austin
08.2004 - 03.2007
Utilization Review Nurse
LK Jordon and Associates
11.2003 - 08.2004
Clinical Research Coordinator
Radiant Research
11.2002 - 11.2003
Clinical Research Nurse/Coordinator
PPD Development
08.2001 - 10.2002
Office Nurse
Austin Endocrine Associates
07.2000 - 08.2001
LVN - LVN program
Western Texas College
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