Team-oriented Clinical Research Associate conducts site selection, site initiation, interim monitoring, and closure visits, at investigative sites. Ensures that clinical studies are conducted, data is accurately collected, and deviations from plan are reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
Certified Clinical Research Associate from the Academy of Clinical Research Professionals
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Following an extensive internal clinical monitoring training, began interim monitoring in June of 2011, at twelve sites for a large Phase 3 Women's Health program that had completed start-up activities. Learned close-out visits while monitoring this program. During a Phase 3 AOMT study, in 2012, learned site selection visits and site initiation visits. Also monitored and closed out four sites for a pediatric study for which I was the sole U.S. monitor, in order to achieve utilization goals and relieve a Senior CRA. Performed co-monitoring and solo monitoring for a diagnostic infectious disease study which utilized paper case report forms, paper DCFs, and manual data collection. Have enthusiastically shared workload during other CRA's sabbaticals, employment turnover, and enrollment surges. Currently monitoring over twenty sites for two identical protocols within a pediatric AOMT program.
- Reviewed Informed Consent Forms (ICF) and Assents, to ensure compliance with Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) Guidelines.
- Performed initial review and processing of Serious Adverse Events reports; prepared and compiled clinical study reports; assisted with regulatory application preparation for IND and NDA
submissions.
- Managed the timely collection, maintenance, and distribution of study
documentation.
- Reviewed and made edits to site-specific ICFs, based on clinical trial regulations, ICH Guidelines and CRO/Sponsor SOP's.
- Performed secondary Essential Regulatory Document review necessary for release of investigational product.
- Wrote study plans for the collection, review and approval of Essential Regulatory Documents.
- Attended and presented at Sponsor meetings.
- Expert in clinical laboratory documentation review required for protocol-specific safety analysis.
- Well-versed in multiple clinical trials involving controlled substances, including narcotic pain relievers, hypnotic sleep medications, benzodiazepines, and Schedule II stimulants.
- Well-versed in Health Canada Submissions and Essential Document review, including the Quebec Multi-centric review process.
Provided timely and professional IRB services for 40+ clinical studies and 900+ investigative sites, within the scope of corporate SOPs and Federal Regulations/ICH Guidelines.
- Maintained strict confidentiality and accuracy of client data via Access database.
- Pre-reviewed and processed the expedited review of subject recruitment materials, revisions to Form FDA 1572, revisions to Subject Information and Consent Forms and translated materials.
- Reviewed and requested modifications to proposed advertisements and subject recruitment/retention materials to ensure clarity, subject safety, and compliance with regulations and SOPs.
- Reviewed submissions for Protocol Amendments, revised Investigator Brochures, revised Package Inserts, Serious Adverse Events, IND Safety Reports, and Continuing Review.
- Reviewed and made edits to Informed Consent Forms (ICFs) templates for sponsored research studies, based on clinical study protocol, Investigator Brochure, ICH Guidelines and CRO/Sponsor SOP's.
Marketed new treatment concept to psychiatry, pain management and addiction medicine specialists in four states.
- Executed special marketing projects, including exhibit planning and the facilitation of educational proposals for annual professional symposia.
- Liaised with substance abuse counselors, state controlled substance authorities and opioid treatment centers to educate the substance abuse community.
Established productive, scientifically-based relationships with key Neuroscience Key Opinion Leaders (KOL's) throughout the Southeast and Mid-Atlantic states.
- Identified and prioritized sales growth initiatives with Zonegran™, a novel anti-convulsant and Diastat™, a rescue treatment for acute repetitive seizures.
- Analyzed physician practices and leveraged relationships for increased revenue and market share for District Managers in eight states.
- Managed an annual budget to cover educational programs, capstone projects, publications and independent investigator grants.
- Coached and developed a regional sales network for 10 professional sales representatives.
- Planned territorial expansion and major market sales recruiting.
- Assisted marketing and product development teams with planning of effective national and regional advisory board meetings.
Won President's Club Sales Award for 1998.
- Regional Trainer, 1997 – 1998. Conducted product and disease state training and mentored new sales representatives. Created study guides for sales representatives to augment corporate training materials for Parkinson's Disease, epilepsy and pain management.
- Completed “Coaching and Counseling” management development training.
- Attained national formulary approval for a new concept product on the Blue Cross Network.
- Promotion of prescription pharmaceutical products to primary care, Obstetrician-Gynecologists, Gastroenterologists, Cardiologists and Urologists.
Led sales and marketing activities for a local home infusion provider to hospital discharge planners, oncologists, infectious disease specialists, orthopedic surgeons, and obstetricians.
Promoted prescription and over-the-counter products to primary care, gastroenterologists, cardiologists, obstetricians, and dermatologists.
Coursework included Anatomy and Physiology, Pathophysiology, Pharmacology, Clinical Research Regulations, Clinical Research Data Management, Clinical Research Monitoring, and Clinical Research Site Management
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