Tracey Owens Email & Phone Number

Remote

Fort Smith, Arkansas Area

Remote

• Manage the execution of the assigned clinical studies per contract, from initiation through to closeout, ensuring all project deliverables are completed to the Sponsor’s satisfaction

• Manages the planning and delivery of the clinical component of global projects in accordance with the scope of work, contracted timelines and study budget

• Manages study start-up and clinical monitoring activities for global and regional multi-operational projects.

• Responsible for monitoring clinical trials: assure adherence to Good Clinical Practices, investigator integrity and compliance with all study procedures

• Responsible for monitoring clinical trials: assure adherence to Good Clinical Practices, investigator integrity and compliance with all study procedures

• Review all Serious Adverse Events and co-ordinate reporting to domestic and foreign regulatory agencies• Write patient narratives, design and manage adverse event databases, and write safety updates and reports• Write and edit IND applications, annual reports, and final reports• Monitor Phase I through IIIb clinical trials in U.S. and Europe

• Coordinate CNS I through III clinical trials with focus on Central Nervous System indications •Manage serious adverse event database for U.S. and European based clinical trials.

• Co-ordinate pharmaceutical clinical drug trials, including indications of cardiac transplant, osteoporosis, and endocrinology related trials.• Facilitate co-ordination of 7 inter-institutional clinical trials, including cancer and diabetes trials.• Recruit subjects, collect and analyze subject data and monitor subject response.• Scan clinical and research subjects using Bone Densitometry machine and analyze results.• Interface with sponsoring pharmaceutical companies. • Collection of biological samples• Write protocols, consent forms, and edit scientific papers and grant proposals.

• Edit reports and legal documents such as license agreements and trademark applications.• Perform patent, trademark, company and other searches