Evolution Research Group

Research Analyst

• Conduct site monitoring responsibilities for Clinical trials, according to Standard Operating Procedures, ICH guidelines, and GCP.
• Manage and monitor site activities for assigned clinical studies, working individually or co-monitoring with other Clinical Research Associates (CRAs).
• Monitoring activities will include but not be limited to site qualification, site initiation, interim monitoring, and close-out visits.
• Ensure compliance with the protocol and applicable Company or Sponsor Standard Operating Procedures (SOPs), FDA regulations, and ICH-GCP guidelines.
• Perform site evaluation visits of potential investigators.
• Evaluate the capability of the site to successfully manage and conduct the clinical study.
• Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the case report forms, monitoring activities and study close-out activities.
• Assist in resolving any issues to ensure compliance with site file audits.
• Direct communication with investigational sites on visit planning, query resolution, action item resolution, and any other activities to support site management.
• Document accountability, stability and storage conditions of clinical trial materials as required by sponsor.
• Perform investigational product inventory. Ensure return of unused materials to designated location or verify destruction as required.
• Serve as primary contact with the site; coordinate all correspondence; ensure timely transmission of clinical data with the study site.
• Perform study close-out visits per the study specific Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
• Ensure internal and study-related trainings are completed per Lotus and/or study timelines.
• Pre and post visit follow up include compliance to timelines indicated in the Monitoring Plan (MP) for Confirmation Letters, Follow up Letters and Monitoring Visit Reports (MVR).

CRO – Contract Clinical Research Associate

QA Engineer

• ensuring that day-to-day clinical trial operations at the CPMI site are conducted in compliance with study protocols, FDA regulations, and ICH/GCP guidelines.
• provides oversight and reporting to Operational Leadership to maintain the integrity and quality of all site activities.
• Conducting internal audits
• Monitoring training completion and associated metrics
• Providing support and consultation for Quality events and CAPAs
• Overseeing and assisting with internal and external audits
• Managing and supervising Quality Control plans and QC staff
• Maintaining all Quality-related activities within the clinic
• supporting the overall Quality Management System for these sites to ensure quality assurance, quality control, compliance, and auditing activities related to study conduct.

GCP Director of Quality Assurance and Compliance

Clinical Research

• Obtain detailed knowledge of all components of each study protocol through review and analysis of study information with Principal Investigator and Site Director prior to the effective date of the study.
• Assist to develop draft source documents and review the documents for accuracy and clarity prior to study start up.
• Review with Principal Investigator and Site Director, any components of the study for which additional information or clarification are required prior to the initiation of the study.
• Manage studies with direct oversight from Site Director, and Principal Investigator to ensure compliance with protocol requirements.
• Manage studies with Principal Investigator, Site Director, and Recruitment Manager to develop effective programs for study enrollment.
• Contribute to the SOP review and development as delegated by the Site Director.
• Perform study activities as delegated by the Principal Investigator and under the supervision of the Site Director.
• Attend the investigator meeting for each assigned protocol, as appropriate with directive from Site Director.
• In conjunction with Site Director and Principal Investigator, ensure adherence to the protocols and document breaches or violations with sponsors and appropriate Institutional Review Boards (IRBs) and other outside regulatory organizations, as required.
• Screen, enroll subjects and schedule subject visits in conjunction with Principal Investigator.
• Review and obtain informed consent from with potential study volunteer.
• Document all written and phone correspondences with sponsor, labs, IRB other regulatory organizations.
• Maintain organized, accurate and complete study records.
• Assist Principal Investigator in conducting studies in manner to ensure integrity of data and safety of subjects.
• Enter data as appropriate for protocol (paper-electronic data capture).
• In conjunction with Principal Investigator, accurately report and track adverse events as defined by each study protocol.
• Perform study close-out procedures.
• Store study records appropriately.

Clinical Research Coordinator

• Responsible for the overall coordination, organization, management, and efficient implementation of clinical trials
• Completes all study related procedures and distributes study medication and instructions to research subjects under the direction of the Principal Investigator and the Site Director
• Maintain accurate, confidential files and documentation of study participants
• Obtain detailed knowledge of all components of each study protocol through review and analysis of study information with Principal Investigator and Site Director prior to the effective date of the study
• Develop draft source documents and review the documents for accuracy and clarity prior to study start up
• Develop a mechanism for subject recruitment and ongoing communications with PCP and nursing staff as appropriate
• Manage studies with sponsor, and Principal Investigator to ensure compliance with protocol requirements
• Manage studies with Principal Investigator, Site Director, and Recruitment Manager to develop effective programs for study enrollment
• Communication of all protocol related issues/problems to the appropriate management staff
• Perform study activities as delegated by the Principal Investigator and under the supervision of the Site Director
• Attend the investigator meeting for each assigned protocol, as appropriate
• Ensure adherence to the protocols and document breaches or violations with sponsors and appropriate Institutional Review Boards (IRBs) and other outside regulatory organizations, as required
• Screen, enroll subjects and schedule subject visits in conjunction with Principal Investigator
• Document all written and phone correspondences with sponsor, labs, IRB other regulatory organizations
• Maintain organized, accurate and complete study records including regulatory documents, signed informed consents, IRB correspondence/approvals, source documentation, drug dispensing logs, subject logs and study-related communications
• Ensure timely and accurate CRF completion for each study subject
• Accurately report and track adverse events as defined by each study protocol

Clinical Research Coordinator – FT

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

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.

CRO – Contract Clinical Research Associate

GCP Director of Quality Assurance and Compliance

Clinical Research Coordinator

Clinical Research Coordinator – FT

Research Assistant

Laboratory Manager