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Developed a module-based curriculum on humane education for at-risk youth in a variety of settings in Northern California.

Responsible for the overall coordination and management of clinical projects to develop a targeted service delivery approach for inmates with serious mental illness to target criminogenic needs. Co-facilitated group cognitive behavioral therapy (CBT) with justice-involved populations to improve interventions responsive to the specific learning and treatment needs of people with serious mental illness.Responsible for compiling and submitting study documents in accordance with NIH audit requirements.Executed registration and maintenance of protocol record on clinicaltrials.gov. Created tracking systems for patient enrollment and data analysis.

Program Instructor: Penny Lane WELL (Wellness, Education, Leadership and Lifestyle) Facilitated small therapeutic group sessions aimed at promoting healthy living and enhancing wellness for individuals with serious mental illness. Topics included psycho-education, mindfulness, nutrition, and dialectical behavior therapy (DBT) life skills.Counselor: UNC Peer Assisted Wellness Support (PAWS)Aided the emotional support dog program to train and facilitate ownership of local shelter dogs for individuals living with chronic conditions to benefit from canine companionship.ŸCounselor: Community Resource Court (CRC)Provided counseling services to clients in Chatham Country Truancy Court.ŸSupported Employment Counselor: Individual Placement and Support (IPS)Assisted clients to enter the workforce and maintain competitive employment.Ÿ Research Assistant: SAMSHA GrantConducted interviews with health care users to collect patient outcome data.

Provided counseling services to patients during hospitalization for heart or lung transplant, including cognitive behavioral therapy (CBT) and mindfulness-based stress reduction (MBSR) techniques.

In this position I was responsible for coordinating and managing Data Safety Monitoring Board (DSMB) meetings. Responsibilities included, but were not limited to identifying and contracting expert physician members, writing DSMB charters, generating and executing appropriate timelines, managing effective communication with members, clients, and internal project staff, and running independent safety review meetings to ensure investigational drugs were safe and efficacious for human subjects.

Served as Regulatory Officer for the submission of U.S. Investigational New Drug Applications to the FDA, and Canadian Clinical Trial Applications to Health Canada.Performed validation of Investigational Drug Product Release requests and Essential Critical Document Reviews, per federal and global regulations as well as company and sponsor SOPs.Ensured work was in compliance with the relevant regulatory guidelines, requirements and Chiltern or Sponsor’s standard operating procedure and style guidelines.

Served as the Data Monitoring Committee (DMC) Coordinator.Assisted Medical Writers in preparing Clinical Study Report Appendices (ICH E3 Section 16).Assisted in the review and quality control process for documents within Medical Writing department.

Delivered superior patient-centered care to physically and mentally disabled clients. Maintained detailed patient records and accurately updated healthcare team on patient’ status, including vital signs.Received excellent patient satisfaction reports.