Evolution Research Group

Manager

• Lead the build-out, start-up, and day-to-day operation of a CLIA-certified and GLP-compliant clinical research safety laboratory.
• Direct and coordinate laboratory personnel to ensure quality, accuracy, and timeliness of laboratory testing and reporting.
• Ensure compliance with CLIA, GLP, GCP, IRB requirements, SOPs, OSHA standards, and applicable regulatory requirements at all times.
• Support CLIA and accreditation readiness activities, including inspections, audits, and corrective actions as needed.
• Oversee quality control, quality assurance, and proficiency testing programs.
• Develop, write, implement, and maintain laboratory SOPs, procedure manuals, and quality documentation.
• Manage laboratory testing menus, including evaluation of new assays, validation planning, and coordination with reference laboratories when appropriate.
• Serve as a key laboratory point of contact for sponsors and internal clinical teams, including participation in study initiation meetings.
• Coordinate sample processing, storage, and shipment in accordance with protocol and sponsor requirements.
• Oversee laboratory supply management, inventory control, and equipment maintenance.
• Manage, mentor, and evaluate laboratory staff, including performance management and timekeeping as applicable.
• Ensure accurate and timely electronic data transfers and laboratory data reporting to sponsors when required.
• Maintain a safe, organized, and inspection-ready laboratory environment.

Laboratory Manager

Research Scientist

• Ensure compliance with protocol and overall clinical objectives.
• Prepare source documents for study visits.
• Perform vitals, ECGs, and phlebotomy.
• Data Entry from patient visit
• Manage lab kit inventory.
• Ship and process specimens
• Undertake protocol trainings as assigned.
• General office tasks such as filing, copying, and scanning.

Research Assistant

QA Engineer

• The Quality Assurance and Compliance Director ensures that all clinical trials are conducted in accordance with study protocols, FDA regulations, and ICH/GCP guidelines by way of internal audits, oversight of training, and the maintenance of all Quality driven activities at the clinic.
• This position is also part of the Quality Mobile Unit (QMU) which requires assistance and support of the overall Quality Management System for ERG to promote quality assurance, quality control, compliance, and auditing activities as they relate to conduct of studies or vendor management.
• As needed or in the absence of the Vice President of QA, lead the Quality Mobile Unit (QMU) team in plan, execution, and analysis of Quality Assurance initiatives as well as external audits for the organization, with direct report to the Vice President, QA.
• In executing these position responsibilities, the Director, Quality Assurance is guided by FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.
• Conduct audits of study documents, Case Report Forms, Informed Consent Forms, and Clinical Study Reports to assure compliance.
• Collaborate with Site Director and study PIs to resolve and document issues promptly and effectively.
• Conduct GCP compliance audits of vendors in accordance with site’s QA Audit Plan.
• Report significant Quality issues to Vice President, Quality Assurance.
• Evaluate results of System and Data Audits and oversees the implementation of corrective actions with input and support by Site Director and Vice President, QA.
• Responsible to facilitate Sponsor Audits and assist with other Sponsor site visits as applicable (and to report results of audits to Vice President, QA).
• Assist with supporting FDA Inspections and preparation activities.
• Oversee training is conducted in accordance with SOPs and records are sufficiently maintained and up to date.
• Responsible for facilitating in conjunction with Vice President QA, Corrective and Preventive Actions (CAPA) and conducting effectiveness checks as applicable.
• Perform any other duties as assigned by Vice President, QA in collaboration with Site Director, as applicable.
• Responsible for communicating site trends to QMU Team and Site Director.
• Assist in maintaining ERGs Quality Management System (QMS) to ensure compliance to Good Clinical Practice (GCP) and that the QMS is aligned with the internal policies and standard operating procedures for ERG.
• Assist in audit activities in the areas of Vendor Audit Management, facilitation of internal & external clinical quality audits, and agency inspections.
• Participate in the oversight of Corrective and Preventive Actions (CAPA) implementation and assist in conducting Quality reviews.
• Active travel to all site clinics to assist with QA initiatives, Corrective actions, training of staff, study preparations or sponsor meetings, as applicable.