We are seeking a Quality Control Coordinator for WRAIR in Silver Spring, MD!Assist in all activities of the Lead Quality Coordinator (QC).
Assist in the review and development of clinical research protocols and Clinical Quality Management plans. (CQMP).
Implement and maintain a viable internal quality compliance function for all activities within the CTC (protocols and Lab area).
Develop internal monitoring plan appropriate for phase, complexity & size of trial.
Review and assure Regulatory Files are maintained and complete in accordance with applicable regulations and guidelines.
Maintain study records in accord with applicable regulations and guidelines.
Facilitate quality assurance monitoring by representatives of USAMMDA or other study sponsors.
Facilitate communication between CTC and other quality groups. Contribute to external audits and inspections when appropriate.
Review protocol specific source forms; subject, lab & IP prior to use.
Discuss deficiencies with staff & recommend modifications as needed.
Review documentation of ongoing studies for accuracy & completeness, documenting deficiencies constructively as queries for the CRC and Investigator, providing references as appropriate to improve study implementation practices; with follow through reviewing responses to ensure they are complete and appropriate.
Manage Department SOPs: Maintain official & archived documents, table of contents, conduct/oversee biannual review process, write & format SOPs in collaboration with other team members, following institution policy.
Recommend appropriate staff training to the SCRC.
Maintain and update on-site archive tracking document for all studies conducted at the CTC.
Coordinate transfer with the WRAIR Archivist (or Sponsor) to off-site location.
Participate in other aspects of conducting clinical trials within CTC as required Provide technical assistance to CRM Headquarters as needed and participate on proposal writing projects when requested.
Provide all job-related progress reports/technical reports as requested.
Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations.
Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.
Performs light duties and other related duties as required and assigned.