Quality Assurance Specialist - CTO

Provides clinical trials auditing andmonitoring and follows established processes to support compliance according to

KCI Data and Safety Monitoring Plan (DSMP) and all applicable regulations.

Provides support for all facets of clinical trials auditing and monitoring with

special emphasis on institutional (investigator-initiated) and Cooperative

Group sponsored trials. This position is integral to the overall compliance of

clinical trial research and the protection of the rights and well-being of study

participants. Facilitates excellent

customer service and guidance in the clinical trial compliance arena. Ability

to manage independent assignments.

Responsibilities :

Conducts a variety of compliance activities

intended to facilitate and assure that clinical trials comply with the

requirements of the protocol, the approving Institutional Review Board, Code of

Federal Regulations, Good Clinical Practice, Food and Drug Administration

(FDA), and KCI’s NCI approved Data and Safety Monitoring Plan.

Conducts auditing and monitoring activities in

accordance with established CTO policies and procedures.

Activities may include : pre-study feasibility

evaluations, ongoing monitoring of studies and study close-out, drug, device

and correlative specimen compliance review.

Reviews the accuracy, completeness and

timeliness of study related records, and case report forms with original source

documents.

Reviews that study related processes relative

to departmental guidelines and SOPs are in compliance.

• Bachelor’s degree and four plus years’ experience coordinating clinical trials : or equivalent combination of education / experience that includes at least five years in the clinical trials arena.
• Medical and / or science experience / education strongly preferred.
• Clinical research certification required for a minimum of one year.
• Clinical trial auditing and monitoring experience preferred.
• Proficient with the Microsoft suite including Excel and Power point.
• Exceptional interpersonal skills required and excellent verbal and written communication skills necessary to effectively deal with individuals both inside and outside the organization from diversified backgrounds.
• Skilled in communicating sensitive / difficult information and maintaining highly confidential information and situations.
• Demonstrated high level of interpersonal skills and analytical ability.
• Excellent writing and organizational skills.
• Demonstrated leadership abilities required.
• Demonstrated initiative and attention to detail.

Equal Opportunity Employer of Minorities / Females / Disabled / Veterans