Melanie Cosby
Cherokee,AL
Summary
Skilled (13+ years) clinical research coordinator with background in managing and overseeing clinical trials. Experience includes coordinating with research teams, ensuring compliance with protocols, managing participant recruitment, data collection processes, study start-up, regulatory and IRB submissions. Possess strong organizational skills, ability to manage multiple tasks efficiently, and capability to ensure accuracy in documentation and reporting. Contributed to improving trial procedures and enhancing data integrity in previous roles.
Overview
27
27
years of professional experience
Work History
Primary Clinical Research Coordinator
Shoals Clinical Research Associates
Florence, AL
11.2011 - Current
- Worked with the principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Followed informed consent processes, and maintained records.
- Gathered, processed, and shipped lab specimens.
- Assisted in the preparation of Institutional Review Board submissions for clinical trials.
- Monitored patient safety during clinical trials according to established guidelines.
- Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
- Provided training to study staff on protocol requirements and GCP regulations.
- Developed case report forms for data collection at investigational sites.
- Collected, processed and delivered specimens from trial participants.
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
- Conducted screening interviews to determine eligibility of possible subjects.
Pre-Admission Testing RN
Eliza Coffee Memorial Hosptial
Florence, AL
06.1999 - 11.2011
- Served as a staff nurse in the Pre-Admission Testing department performing pre-op testing for patients with planned surgical procedures.
- Communicated with healthcare team members to plan, implement and enhance treatment strategies.
- Equipped patients with tools and knowledge needed for speedy and sustained recovery.
- Worked closely with anesthesia department and admitting physician.
- Evaluated patient histories, complaints and current symptoms.
Medical-Surgical Registered Nurse
Florence Hospital
Florence, AL
06.1997 - 06.1999
- Educated patients and families on medical-surgical procedures, therapeutic regimens and pain management techniques.
- Managed caseload of 10-12 patients simultaneously by providing bedside care, treatments, IV therapy and wound care.
- Offered care and support to individuals recovering from acute incidents and dealing with chronic conditions.
- Administered different therapies and medications in line with physician orders and treatment plan.
Education
Bachelor of Science - Nursing
University of North Alabama
Florence, AL05.1997
Skills
- Good Clinical Practice
- RN License
- IATA Certification
- BLS Certification
- EDC Modules
- Medication Dispensing
- Lab Specimens and Collections
- IRB Submission
- Participant screening
- Informed consent
- Investigator coordination
- Patient recruitment
Timeline
Primary Clinical Research Coordinator
Shoals Clinical Research Associates
11.2011 - Current
Pre-Admission Testing RN
Eliza Coffee Memorial Hosptial
06.1999 - 11.2011
Medical-Surgical Registered Nurse
Florence Hospital
06.1997 - 06.1999
Bachelor of Science - Nursing
University of North Alabama
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