Dorian Key

PO BOX *****

Raleigh, North Carolina 27624

Phone: 919-***-****

E-mail: adtao6@r.postjobfree.com

OBJECTIVE:

To utilize academic talent and professional resources in clinical research and patient safety. To work and

form integrity driven partnerships. While providing dedication and self-motivated professional

experience.

EDUCATION:

Graduated: May 2007

Saint Augustine’s College, Bachelor of Arts in Sociology

Graduated: December 2016

Capella University, Masters Public of Health

Clinical Site Manager II

PAREXEL Durham N.C. November 2020-Present

Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities

Generate visit/contact reports in accordance with monitoring plans

Configure, distribute, collect, review, and approve high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.

Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections as required

Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.

Clinical Monitoring Associate II

SYNEOS HEALTH Durham N.C. November 2019-November 2020

Review and understand the protocol, critical data and process, safety, and data integrity risks related to protocol execution.

Review patient data listings and visualizations via analytical dashboards and/or reports to confirm eligibility, identify protocol deviations, patient safety concerns, data integrity issues and illogical/inaccurate/missing data.

Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.

Immediately communicates/escalates serious issued to the project team and with guidance develops action plans.

Documents observations noted during reviews and writes queries, protocol deviations or action items as necessary in appropriate systems for action by sites, CRAs or other functional team members.

Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations and company SOPs/processes.

Access vendor systems or reports to verify the IP has been dispensed and administered to subjects/patients

According to the protocol, that laboratory and other procedures have been performed, that eTMF data is current and complete.

Documents completion of activities via tracking, reporting and/or other required project documents as per SOPs and monitoring plan.

Prepare for investigator/sponsor meetings

Clinical Site Manager I

PAREXEL Durham N.C. October 2017-November 2019

Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities

Generate visit/contact reports in accordance with monitoring plans

Configure, distribute, collect, review, and approve high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.

Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections as required

Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.

Clinical Monitoring Associate

PAREXEL Durham, N.C. February 2015-October 2017

Collect regulatory documentation and ensure accuracy

Collect drug and supply management

Receive inbound and outbound calls

Address protocol questions

Resolve issues from previous visits.

Review site payments

Perform data entry

Monitor clinical trials from pharmaceutical companies and in house

Conduct visits and preside over pre-qualifications, qualifications, invitation, monitoring, and termination

Review recruitment plan and enrollment updates

Clinical Technician

Duke University Medical Center Durham, N.C. June 2011- February 2015

Participates in the delivery of patient care at an advanced level, which includes a variety of technical tasks, performed in an effective and efficient manner.

Performing various administrative duties such as documenting patient and clinical reminders, scheduling follow-up visits, and maintaining control records and test

Conduct routine tests that can have the potential to help save a patient’s life.

Pharmacy Technician

Super Wal-Mart Raleigh, N.C. January 2007- May 2017

Dispense prescription medication

Provide excellent customer service

Manage money

Assist in billing insurance issues

Data Collection Specialist

Social Scientific Solutions Morrisville, N.C. January2010- January 2011

·Conduct thorough research on patient account statements and medical records by maintaining HIPAA compliance.

·Call center environment placing outbound calls to: Pharmacies, medical offices, and hospitals.

·Daily performance includes: Combination of calls, Record Abstracting, QA, and Data Entry.

·Medical Terminology.

·Medical Billing/ Insurance (EOB’s, UB-04s, 1500 Forms, and Itemized Bills).

·Provide training to new staff and others as needed.

SKILLS:

Excellent Customer Service Skills

CPR and First Aid Certified

Certified Pharmacy Technician

ACTIVITIES:

Member of Sociology Club

Contact this candidate