Michael Watts Email & Phone Number

Indianapolis, Indiana, United States

Indianapolis, IN, United States

Indianapolis, IN, United States

Indianapolis, IN, United States

· Detailed understanding of Pharmacovigilance operations for both large sponsors and CROs.· Understanding of global regulatory distribution requirements as it relates to investigator notification of safety events.· Guide clients to optimize system configurations and study start-ups· Serve as the point of escalation for clients in the administration of.

· Control electronic regulatory files, including essential document collection and trial master file maintenance.· Create and maintain required documents for filing of required information to FDA, including new Investigational New Drug (IND) applications, updates to INDs, and annual reports.· Ensure all IRB approvals and regulatory essential documents are.

Indianapolis, Indiana

· Received and processed all IND Safety letters.· Reviewed incoming SAE documents for completeness and clarity and communicates with submitting site to resolve any documentation issues with SAE report.· Communicated SAE information to funder per protocol guidelines and/or study specific Safety Management Plan.· Created Medwatch Report form and notifies.

· Advised and consulted patients with receiving specific therapies that are program specific· Managed difficult callers, adverse events, and product complaints.· Resolved product complaints for frustrated clients· Fielded and processed patient assistance applications and refills

Indianapolis, Indiana Area

-Facilitated activities and games.-Created an enriching environment for children from Pre-K to fifth grade. - Oversaw and assisted students during after-school study hall.

Cincinnati Area, KY

• Managed inventory of Investigational Product/drug accountability for Clinical Trials.
• Conducted qualification, initiation, monitoring, and closeout visits for research sites in compliance according to the FDA, SOPs, GCP, and approved protocols.
• Evaluated efficacy, accuracy, and authenticity of clinical research data stored in the EMR and on the Case Report Forms.
• Completed monitoring reports and follow-up letters, which provided summaries of significant findings, deviations, deficiencies, recommended actions to secure compliance, and met all deliverables on time.
• Assessed clinical research sites, patient recruitment, retention success, and contributed to improving processes.
• Verified and reviewed adverse events, concomitant medications, and corresponding illnesses to confirm accurate data reporting in accordance with the protocol.

Cincinnati Area, KY

• Collaborated with management for a conduction of a quality control review of SOPs for a FDA and Sponsor Audit.
• Performed in-house CRA task including site contacts, data management, and validated closeout destruction forms.
• Created and maintained SharePoint sites and libraries for Clinical Trails including an ENT, diabetes, and lipid studies.
• Created Recruitment Efforts for CRA’s including professional organizations and the Rose Hulman partnership program.

• Mentor to Campers and responsible for 90/7-8 year olds
• Help with opening and closing ceremonies
• Monitor the kids of Camp Tecumseh

Indianapolis, Indiana Area

• Assisting in organizing and planning Big Red Bash.
• Assisting with leading Door to Wellness.
• Marketing and promoting Camp Little Red Door.
• Interacting with the clients during the various events and activities.

Muncie, Indiana Area

- Provide quick and effective professional customer service.- Developing professional interpersonal skills.- Manage large parties at one time.

Muncie, Indiana Area

-Provide quality and effective customer service in a fast-paced environment.-Develop strong interpersonal communication skills with talking with the customer and the thousands of restaurant guest.- Maintain the up keep of the facility.

Muncie, Indiana Area

Organized Fruit Area and Dish roomRecommended items for Customer to tryWork in a fast-pace environment

Muncie, Indiana Area

• Collected and Filed documentation for Cancer Screening
• Collaborated with Health Educator in the Oncology Unit
• Communicate and Direct Hospital Guest and Patients