Quality Control Mgr

Job Summary :

Under general direction of the Director, Clinical Research, this management level position is responsible for overseeing the quality of the work product produced by the CTO.

This position will develop, implement and maintain formalized SOPs and training modules and is responsible for performing audits of work areas to ensure quality standards are maintained.

Quality Assurance staff within the CTO report directly to this manager. Regular reports are written and provided to the CRO Administrative and Associate Directors.

While this position will confer with all senior management, this is an independent position what reports only to the Assistant Director, Research Administration.

Specific Responsibilities :

QC Program Development Responsible for the establishment of a comprehensive quality control program for the CRO. This position will develop and initiate formalized standard operating procedures and a comprehensive training program for all staff (new and ongoing).

This position will be further responsible to work directly with the CRO upper level managers in the development of SOPs specific to our role as the sponsor of clinical research.

This position will oversee the process for review of SOPs annually and will document training on new SOPs, as needed; therefore to ensure continued federal and institutional compliance the position must regularly monitor the field to ensure (s)he is up-to-date with current research standards.

A method of documenting staff compliance with training activities will be developed and maintained.

Training Activities This position is responsible to ensure appropriate procedures are in place for regular and ongoing training for all CRO staff, including incorporation of required external training (e.

g., training required by the NU IRB, ECOG, etc.). Training activities may be in many formats, i.e., in-person training sessions, web-based training modules, remote training via teleconference, and distribution of and testing on written materials.

This position will ensure that training is tracked for each employee and is responsible for ensuring all staff members comply with training requirements.

Will confer with management staff on training activities as needed.

Audit Activities Responsible for the audit program of work areas within the CRO to ensure compliance with federal and institutional requirements and SOPs, to ensure quality standards are maintained.

Audits will take place on a regular basis and feedback will be provided to managers and staff regularly. Will monitor the conduct of the QA coordinators auditing responsibilites to ensure these are appropriately met.

Will confer with management staff as needed.

Reporting Activities Provide regular, comprehensive reports to the Cancer Center senior leadership on QA / QC activities and results.

This manager will be in a position to make recommendations regarding staffing decisions and will provide feedback to supervisors for the purposes of performance review (PEX).

Miscellaneous

Performs other duties as assigned.

Minimum Qualifications :

• Bachelors degree in business administration, public administration or a health sciences field and 3-5 years of regulatory or research experience or the equivalent combination of education and experience from which comparable skills can be acquired.
• Prior experience coordinating (clinical and / or regulatory activities) or monitoring therapeutic clinical trials.
• Prior experience in staff education and training activities.

Minimum Competencies : (Skills, knowledge, and abilities.)

• Excellent written and oral communications skills.
• Strong research and regulatory background as demonstrated by knowledge of the Code of Federal Regulations and Good Clinical Practice guidelines.
• Strong organizational and interpersonal skills.
• Strong computer skills.

Preferred Qualifications :

• Excellent written and oral communications skills.
• Strong research and regulatory background as demonstrated by knowledge of the Code of Federal Regulations and Good Clinical Practice guidelines.
• Strong organizational and interpersonal skills.
• Strong computer skills.
• Prior experience in the development and roll out of SOPs and training strongly preferred.
• Prior management experience is preferred.

Preferred Competencies : (Skills, knowledge, and abilities)

Knowledge of cancer research, in particular, is preferred.

Target hiring range for this position will be between $$70,500-$90,500 per year. Offered salary will be determined by the applicant’s education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data.

Benefits :

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Northwestern University is an Equal Opportunity, Affirmative Action Employer of all protected classes, including veterans and individuals with disabilities.

Women, racial and ethnic minorities, individuals with disabilities, and veterans are encouraged to apply.