Therapeutic Experience:

Infectious Disease ￨ Cardiovascular ￨ Oncology ￨ CNS / Neurology ￨ Respiratory ￨ Gastrointestinal

• Dynamic CRA who offers a background in Clinical Research, Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines, Strategic Analysis / Planning, Team Building / Training, Regulatory Compliance, and Client Relations; contributes talent in Nursing, Healthcare Operations, Treatment Planning, Records Management, Time Management, and Work Prioritization; and exhibits an ability to see the big picture at all times.
• Top Performer who boasts above-average career results, and can make sound decisions to reflect positively on operations in alignment with a strategic project s vision, value, and goals to attain significant clinical results.
• Visionary Leader with commendable achievements across a current workload of three protocols and two therapeutic areas (Cardiovascular Phase II / III; Pain Phase III) with 11 sites, and can rise above challenges.
• Excellent Communicator who builds and sustains synergistic relationships with project management, specialists, line management, research peers, and clients, and excels in autonomous and collaborative work environments.

Clinical Research Associate II

  Capitalize on the opportunity to lead forward-thinking site selection, initiation, monitoring, and close-out visits in accordance with contracted scope of work and Good Clinical Practices (GCP), including comprehensively monitoring visits and site management for wide-ranging protocols, sites, and therapeutic areas to meet objectives.

  Expertly administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues, including evaluating quality and integrity of study site practices related to proper conduct of protocols and adherence to applicable regulations.

  Escalate quality issues to Clinical Project Manager (CPM), Clinical Research Specialist (CRS), and / or line manager.

  Manage progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completions and submissions, and data query generation and resolution.

  Create and maintain appropriate documentation regarding site management, monitor visit findings and action plans by submitting regular visit reports, and generate detailed follow-up letters and other documentation.

  Motivate investigators in order to achieve recruitment targets, and communicate with Clinical Trial Manager.

  Ensure the correct storage of drugs and the diligent account of all drugs in accordance with the sponsors SOP.

Clinical Research Associate

  Strategically steered site evaluation, study initiation, and clinical monitoring and close-out visits, including investigating sites to ensure adherence to results-generating procedures, protocols, and project plans in accordance with FDA regulations and GCP / ICH guidelines, as well as comprehensively monitoring clinical trials.

  Expertly conducted pre-study visits to assure the site had adequate facilities, staff, and subject population for conducting the study within established timeframes and in compliance with regulations and all GCP guidelines.

  Distributed supplies to study sites and assured adequate quantity of supplies during course of the various studies.

  Optimized data / recordkeeping practices by ensuring events were properly recorded and reported, along with ensuring regulatory documents were complete and reviewing site-generated ICFs for compliance with protocols.

  Led targeted feedback to Clinical Trial Team Lead on data management documents (e.g. coding plans) for studies.

  Built productive operations by training investigators, coordinators, and other trial staff in data collection methods to ensure collection of patient data that was accurate, complete, and conforms to project standards.

Registered Nurse

  Played a vital role in coordinating quality-focused patient care, including initiating and / or updating care plans; administering IVs, medication, and equipment; and assessing patients for medication side effects, as well as promoting treatment to patients with different diagnoses and proper follow up of patient conditions.

  Expertly evaluated patients mental and physical status upon admissions and every 24 hours, along with implementing, assessing, and documenting patient care interventions and responses; attending daily patient rounds; and making appropriate recommendations regarding clinical and programmatic needs of all patients.

  Initiated multi-disciplinary treatment plans, including ensuring elements were reviewed and / or revised as required.

  Exhibited solid communication skills toward educating patients and families in disease processes and prevention.

Bachelor of Science in Nursing

Bachelor of Science

Microsoft Office (Word, Excel, PowerPoint, Outlook) ￨ Internet Applications

Excellent Professional References Provided Upon Request