Clinical QA Specialist

CLINICAL QA SPECIALIST

COMPANY INFO:

MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries.  We specialize in the nationwide recruitment of clinical trials personnel.

 

Our client is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials and is seeking to add a Clinical QA Specialist to their team in Montville, NJ.

 

RESPONSIBILITIES:

- Develop, implement and deliver training processes regarding single AE case handling, US Periodic Safety Report (PSR) and PSUR submissions, US label updates.

- Perform ongoing analyses of compliance findings as outlined by the Compliance Officer, plan and implement corrective actions and further training as necessary.

- Perform QA and collect and analyze QC findings of single case AE reports in accordance with global company standards in order to maintain consistent case quality and accuracy. Compile findings and communicate to the TA's, Compliance Officer and other staff. 

- Communicate and negotiate with heads of Therapeutic Areas, IDSMs to plan, implement and deliver ongoing training based upon compliance monitoring findings.

- Assure training of local and global SOP, WP and local US processes and operations is provided to all staff.

- Ensure that necessary training regarding AE processing and regulations is provided to the external groups such as offline affiliates, CROs, Sales force, other departments involved in AE collections.

 

QUALIFICATIONS:

- Comprehensive knowledge of safety policies and procedures, along with FDA and ICH principles of SAE/AE reporting and proficient understanding of regulatory roles and regulations locally as well as globally is critical.

- Superior oral and written communication skills are critical.

- The ability to develop cooperative working relationships with all levels of staff is crucial.

- Quality traits of diplomacy, professionalism, tact, and arbitration are essential to this position.

- Poise and the ability to present instructional material to diverse groups is a key skill.

- The aptitude to organize, analyze and summarize information and communicate results is required.

- Expert usage and understanding of medical terminology is essential.

- Accomplished and expert knowledge of the coding techniques required of incoming serious and non-serious adverse events using terminology prescribed by global regulatory authorities is crucial.

 

EDUCATION:

- BS in a life-science discipline with a minimum of six years experience in the pharmaceutical industry. Three years of drug safety experience (either in a drug safety department or equivalent clinical setting) is required.

 

MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.