Sr. Director of Clinical Laboratory Operations - CRO
SummaryOur client is currently searching for a Sr.
Direct of Clinical Laboratory Operations who will be responsible for regulatory compliance and accreditation, strategic planning, budgeting, quality assurance, provider relations, and creating an environment conducive to efficient daily operations.
ResponsibilitiesEstablish the strategic goals and objectives, plan, staff, direct activities, and assure operational and financial effectiveness for the Clinical Laboratory.
Responsible for direction and coordination Clinical Laboratory personnel.
Creates and conducts quality assurance and control procedures for specimen processing.
Identify the need for policy development and/or revision, defines policies in collaboration with higher level management input, goals and objectives.
Develop, monitors and revises functional processes.
Responsible for recognizing results or problems that require referral to the Medical Director.
Maintain performance improvement activities within the department and participates in Clinical Quality Improvement activities.
Ensure that laboratory is in compliance with regulatory and licensing agencies.
Provide input into the development and revision of organizational structure for function or service for the laboratory.
Ensure the timely completion of performance appraisals.
Assist in development of and monitors budget for a major function, multiple units/areas, or processes.
Select and implement new laboratory instruments, testing methods and reagents.
Collaborate with research sponsors to develop and implement new laboratory services that are required by their protocol.
Develop and implement laboratory staff technical training programs and competency tests.
Provide the laboratory staff with protocol-specific training Create and conduct Quality Assurance and Quality Control activities to ensure laboratory instruments are properly maintained and functioning appropriately, quality control material is run as describe in the technical SOP, and that the control material is given the correct results:
Develop and maintain an accurate price listing for laboratory services.
Assist the Business Development Department with the review of new research trial proposals to outline the laboratory capabilities.
Good Laboratory Practices - a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical (including pharmaceuticals) non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests.
Good Clinical Practice (GCP) - quality standards that are provided by ICH, an international body that defines a set of standards, which governments can then transpose into regulations for clinical trials involving human subjects.
Customer and Personal Service - Knowledge of principles and processes for providing customer and personal services.
This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction.
Responsible for supervising and mentoring the entire Clinical Laboratory staffQualificationsREQUIRED current or previous experience working for a CRO (Contract Research Organization) Masters in relevant field plus at least 7 years related experience; OR Bachelors in relevant field with at least 15 years related experience.
At least 7 years managing laboratory staff in a CLIA-certified clinical laboratory environment.
Additional Eligibility Qualifications (certifications or licenses) MT (ASCP) or equivalent certification required.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
Direct of Clinical Laboratory Operations who will be responsible for regulatory compliance and accreditation, strategic planning, budgeting, quality assurance, provider relations, and creating an environment conducive to efficient daily operations.
ResponsibilitiesEstablish the strategic goals and objectives, plan, staff, direct activities, and assure operational and financial effectiveness for the Clinical Laboratory.
Responsible for direction and coordination Clinical Laboratory personnel.
Creates and conducts quality assurance and control procedures for specimen processing.
Identify the need for policy development and/or revision, defines policies in collaboration with higher level management input, goals and objectives.
Develop, monitors and revises functional processes.
Responsible for recognizing results or problems that require referral to the Medical Director.
Maintain performance improvement activities within the department and participates in Clinical Quality Improvement activities.
Ensure that laboratory is in compliance with regulatory and licensing agencies.
Provide input into the development and revision of organizational structure for function or service for the laboratory.
Ensure the timely completion of performance appraisals.
Assist in development of and monitors budget for a major function, multiple units/areas, or processes.
Select and implement new laboratory instruments, testing methods and reagents.
Collaborate with research sponsors to develop and implement new laboratory services that are required by their protocol.
Develop and implement laboratory staff technical training programs and competency tests.
Provide the laboratory staff with protocol-specific training Create and conduct Quality Assurance and Quality Control activities to ensure laboratory instruments are properly maintained and functioning appropriately, quality control material is run as describe in the technical SOP, and that the control material is given the correct results:
Develop and maintain an accurate price listing for laboratory services.
Assist the Business Development Department with the review of new research trial proposals to outline the laboratory capabilities.
Good Laboratory Practices - a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical (including pharmaceuticals) non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests.
Good Clinical Practice (GCP) - quality standards that are provided by ICH, an international body that defines a set of standards, which governments can then transpose into regulations for clinical trials involving human subjects.
Customer and Personal Service - Knowledge of principles and processes for providing customer and personal services.
This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction.
Responsible for supervising and mentoring the entire Clinical Laboratory staffQualificationsREQUIRED current or previous experience working for a CRO (Contract Research Organization) Masters in relevant field plus at least 7 years related experience; OR Bachelors in relevant field with at least 15 years related experience.
At least 7 years managing laboratory staff in a CLIA-certified clinical laboratory environment.
Additional Eligibility Qualifications (certifications or licenses) MT (ASCP) or equivalent certification required.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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