Clinical Research Project

Christopher Chiedu

Phone: *****************@*****.***

* ***** ** ******** ******** experience: Therapeutic Areas include: Central Nervous System, Cardiovascular, Oncology, Infectious Disease, Medical Device -

● Ability to perform PSSVs, SIVs, IMV, and COVs and SWAT visits.

● Ability to travel 80% of the time

● Effective clinical monitoring skills

● Experienced in working in Phases I, II, and III.

● Comprehensive knowledge of ICH GCP guidelines including understanding of FDA regulations.

● Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.

● Solid grasp of Institutional Review Board (IRB) procedures and compliance pertaining to the handling of ethical issues in research.

Experience

Parexel

Clinical Research Associate III June 2010-Present

-Manage and monitor different aspects of clinical trials according to study protocols, SOPs, ICH-GCP & FDA guidelines

-Verify qualification of potential clinical trial sites, initiates clinical trials at investigative sites, instructs site personnel

-Prepare and report the site status information to team members, trial management

-Ensure sponsor & investigator obligations are being met & compliant with local requirements and ICH-GCP

-Review and verify accuracy of clinical trial data collected from investigative sites.

-Verify ICF are obtained, written and signed by the clinical trial subjects prior to their participation

-Escalate site on trial related issues in accordance with sponsor’s SOPs until the said issues are addressed or closed.

-Ensure sites report and document Adverse Events, Serious Adverse Event & safety issues appropriately.

-Conduct site equipment inspection and site SOP to ensure patient safety and adherence to protocol.

-Ensure drug accountability logs are kept and procedures on investigational products are followed.

-Ensure PI and the site staffs have a proper understanding of the protocol, and re-train site staff violating protocol.

-Reconcile the Site Master File with the Trial Master File & maintains site's regulatory binder and TMF.

- Reported monitoring activities and study site conduct accurately and completely.

- Provided regular clinical status information to team members and project management

- Performed billable work in accordance with company policies, procedures, and Standard Operating Procedures

- Served closely with other team members to ensure timely resolution of project and/or clinical issues and obtained direction from more senior clinical operations staff

- Communicated common site trends to Lead CRA and other project team members

- Performed investigative site file reconciliation; requested any new or updated site-related essential and non-essential documents and reviewed them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements

- Performed source document verification, retrieved Case Report Forms (CRFs) and performed query resolution in a timely manner and performed drug accountability and safety at investigative sites

- Ensured Serious Adverse Event (SAE) and Serious Adverse Device Event (SADE) reporting according to project specifications.

- Responded to requests from investigative sites in a timely fashion

- served as a resource for and interacted with other functional areas to resolve site issues and facilitated project timelines

Tufts Medical Center Boston, MA Clinical Research Coordinator Aug 2009-June 2010 Participated in subjects’ Inform Consent process with PI to obtain appropriate signatures, dates on forms.

-Documented AE, including: describing the event, severity and frequency, treatment and resolution.

-Implemented recruitment strategies in accordance with IRB requirements and approvals.

- Maintained communication & correspondence with subjects, sponsor, monitor site study personnel’s.

- Screened subjects’ eligibility using protocol specific I/E criteria.

-Proficient in data entries: web-based source documentation; EKG, and vital signs and updating temperature logs

-Experienced in laboratory procedures: safety, quality control and standard operating procedures.

-Coordinated monitoring visits, assist PI & promptly reported unanticipated problems involving risks to participants.

-Maintained accurate records, study drug dispensing/return, drug storage per protocol, lab supplies.

- Monitored progress of clinical trial ensuring conduct, data records and reports are in accordance to labs SOPs.

- Reviewed Clinical Data from Source Documents to ensure subject safety through proper training,

- Resolved queries and random study site issues and prevent protocol deviation and regulatory penalties.

- Appropriately reported AE in accordance to project specifications and regulatory mandates. Education:

Bachelor of Science, Marketing from University of Port Harcourt, 2008 Master Project Manager from American Academy of Project Management, USA, 2017 Skills

● Excellent planning, organization,and problem solving abilities

● Computer competency:Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)

● EDC- Medidata and Inform- CTMS- Impact

● Excellent internal/external communication,writing,multitasking and interpersonal skill

● Time Management Flexibility and versatility. Multitasking oriented Strong Customer focus oriented

● Methodical and meticulous nature with attention to detail with an ability to motivate and organize others. 2

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