Michael Johnstone Email & Phone Number

East Hanover, Nj, Us

Florham Park, Nj, Us

General over site of two clinical trial locations in Belleville, NJ and Montclair, NJ. Responsible for the management of site clinical trials, site clinical trial staff members, and the conduct of site clinical trial activities according to the defined project-specific quality and performance standards.• Completion of clinical trial start up procedures such as: sourcing clinical trials, site feasibility surveys, CDA, 1572, delegation logs, CTA, budget, FDF, GCP, site feasibility forms, SIV, etc.• Serve as principal point of contact between sponsors, CROs, and IRBs. This includes participating in Web Ex's, in person meetings, and daily communication via phone and emails.• Responsible for performing informed consents for clinical trial patients. This includes developing the practices Standard Operation Procedures for conducting informed consents. • Lead abstractor and entry of clinical trial data for EDC systems, and oversight for OCM data abstraction

Responsible for conducting site's clinical trial activities according to the defined project-specific quality and performance standards. These activities are listed below.• Conducting patient informed consents.• Study procedures and follow up assessments.• Coordination, abstraction, and entry of clinical trial data.• Responsible for maintenance of clinical trial records. Including patient and regulatory records.• Ensured clinical trial was properly managed and compliant with various clinical trial and state regulations. • Assisted in the completion of clinical trial regulatory documentation such as: delegation logs, licenses, 1572s, FDF, CDA, budgets, etc.• Participated in clinical trial monitoring visits and clinical trial meetings.Additionally I participated as a member of the practices Oncology Care Model Team (OCM). In this position I acted as lead data abstractor for OCM patients.

In this position, I was responsible for the retrieval, scanning, and management of health information such as medical notes, pathology reports, laboratory reports, radiology scans, insurance information, correspondence, etc., into patient’s electronic medical records. This lead to assisting in the development of the practices SOP to ensure patient records are properly completed, assembled, coded, and signed. Additionally I was responsible for the authorization of information released from patients electronic medical records.

Worked along side members of Van Dyk's activity department. My tasks consisted of assisting members of the department in residents daily scheduled activities. This included leading my own group activities for residents as well as accompanying my supervisor in weekly administration meetings.

Assisting practice with Reporting Clinical Quality Measures (CQMs) for Physician Quality Reporting System (PQRS) and Meaningful Use.

Clinical observation at Joint Care Physical Therapy under the direct supervision of Jonathan Di Lauri.

Clinical observation at Clara Maass Medical Center under the direct supervision of Dr. Jimmy Paulo.

Assisted in the organization, planning, and directing of the practices implementation and transition to Electronic Health Records. Responsibilities included data entry, organization, scanning, copy, and retrieving documents.

Masters Of Science In Health Sciences In Clinical Research Administration

Master Of Science - Ms, Health Sciences In Clinical Research Administration

Bachelor Of Science - Bs, Public Health