At K2 Medical Research, our mission is to bring tomorrow’s treatment today. We are committed to fighting diseases and conditions that plague our families and our local community. If you have a passion to make a difference in the community and they world, then K2 is the right place for you!
We are now hiring for a Quality Control Manager to join our team.
The QC Manager supervises and provides administrative management of the QC Associates. The QC Manager also monitors and performs routine compliance checks on all source data in alignment with protocol requirements and in compliance with ICH-GCP, FDA Regulations, and K2 Medical Research SOPs.
Responsibilities may include but are not limited to:
-Manages the training and workload scheduling/requirements for direct reports
-Assists in the tracking and reporting of compliance trends and metrics
-Review of source documents to verify subjects meet Inclusion/Exclusion criteria per protocol requirements to verify eligibility prior to randomization
-Create queries for the Project Managers to address missing or incomplete source records or to clarify requirements in the source records
-Ensure response to all queries are resolved in a timely manner prior to Subject randomization and sponsor monitoring visits
-Work closely with the EDC department to make sure all clinical data entered in respective electronic systems are verified in a timely manner.
-Communicates compliance trends and reports significant quality issues to the Quality Assurance Department
-Provides training as needed to Project Managers
-Perform ad-hoc projects or other assigned duties on as needed basis
-Excellent verbal and written communication skills.
-Excellent interpersonal, negotiation, and conflict resolution skills.
-Excellent organizational skills and attention to detail.
-Excellent time management skills with a proven ability to meet deadlines.
-Strong analytical and problem-solving skills.
-Ability to prioritize tasks and to delegate them when appropriate.
-Ability to act with integrity, professionalism, and confidentiality.
-Thorough knowledge of employment-related laws and regulations.
-Proficient with Microsoft Office Suite or related software.
-Proficiency with or the ability to quickly learn the organization’s HRIS and talent management systems.
Education and Experience:
-Bachelor’s Degree required; CCRA and/or CCRP preferred
-Minimum 5 years of clinical research and management experience with at least 3 years of patient care experience
-Applicants that don’t meet 100% of the above qualifications but who have a combination of related education, applicable experience, demonstrated capability, and a genuine passion for success in this position may also be consider. We offer a flexible schedule, competitive salary, benefits, bonuses, and advancement opportunities.