Melissa Blankenship
Yukon,OK
Summary
Knowledgeable Clinical Research Associate experienced in documenting and assisting in clinical trials. Achieved effective trial management through strong written communication and thorough knowledge of FDA and GCP principles and regulations. Focused on supporting project teams, evaluating sites, and adapting to new processes.
Overview
1
1
Certification
1
1
year of post-secondary education
11
11
years of professional experience
Work History
Clinical Research Associate
IQVIA
Oklahoma City, Oklahoma
12.2021 - Current
- Conducted site visits to monitor compliance with clinical study protocols.
- Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
- Collaborated with investigators to ensure accurate data collection and management.
- Reviewed and approved informed consent documents for participant enrollment.
- Trained site staff on study procedures and documentation requirements.
- Performed pre-study site evaluations, site initiations, interim monitoring and study close-out visits while collecting regulatory documentation.
- Maintained accurate records of trial progress and participant status updates.
- Evaluated adverse events and reported findings according to regulatory guidelines.
- Monitored safety events reported during the course of clinical trials in accordance with SOPs.
- Analyzed collected data for accuracy prior to database lock; identified discrepancies when necessary.
- Facilitated communication between study sites and project teams to streamline operations.
- Facilitated collaboration with sponsors to ensure project alignment with CROs, investigators, vendors, and subcontractors.
- Prepared reports summarizing study progress and results for senior management review.
- Assessed incoming source documentation for accuracy and completeness against case report forms.
- Attended investigator meetings to provide framework for successful research studies by establishing responsibilities.
- Conducted site initiation visits and monitored ongoing studies at investigator sites.
Clinical Research Nurse
University of Oklahoma
Oklahoma City, OK
11.2015 - 12.2021
- Coordinated patient recruitment for clinical trials at a leading research institution.
- Monitored patient health and safety during clinical study procedures.
- Administered medications and treatments as per study protocols and guidelines.
- Documented patient responses and maintained accurate study records.
- Collaborated with multidisciplinary teams to ensure protocol compliance.
- Educated patients on trial protocols, expectations, and potential risks.
- Assisted in training new staff on clinical procedures and best practices.
- Provided education to patients, families and healthcare providers about clinical trial protocols and informed consent process.
- Collaborated with multidisciplinary teams to ensure successful completion of projects within timeline constraints.
- Documented adverse events and reported them in a timely manner.
- Assessed and monitored patient eligibility criteria for clinical trials.
- Organized and maintained research databases using software programs such as REDCap or EPIC EMR.
- Coordinated communication between investigators, sponsors, vendors and other research personnel involved in the clinical trial process.
- Monitored laboratory results for trends that could indicate potential problems with study medications or treatments.
- Performed physical assessments on study participants according to protocol guidelines.
- Recruited, interviewed and enrolled patients to increase number of participants.
- Participated in training sessions related to Good Clinical Practices or International Conference on Harmonisation guidelines.
- Administered oral, IV and intra-muscular medications and monitored patient reactions.
- Responded to emergency situations with speed, expertise and level-headed approaches to provide optimal care, support and life-saving interventions.
- Maintained strict patient data procedures to comply with HIPAA laws and prevent information breaches.
- Utilized computerized Resource and Patient Management System (RPMS) and Electronic Health Record (EHR) system.
Education
Bachelor of Science - Nursing
University of Oklahoma
Oklahoma City, OK 08.2010 - 05.2011
Skills
- Clinical trial monitoring
- Data analysis
- Regulatory compliance
- Consent review
- Site evaluation
- Collaborative teamwork
- Attention to detail
- Problem solving
- Time management
- Detailed documentation
- Source document verification
- Monitoring visits
- Patient safety
- Site management
- Site monitoring
- Consent process
- ICH guidelines
- Drug accountability
- Accountability
- Clinical practice
- Trip reports
- Study protocols
- Adverse event tracking
Certification
- Registered nursing license, date issued June 2011
Timeline
Clinical Research Associate
IQVIA
12.2021 - Current
Clinical Research Nurse
University of Oklahoma
11.2015 - 12.2021
Bachelor of Science - Nursing
University of Oklahoma
08.2010 - 05.2011