Evolution Research Group

Conversion Rate Optimizer

• Support Clinical Operations to ensure studies are completed, on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.
• Archive and organize clinical trial master file documents, including clinical study site documents, generate filing indexes and maintain currents lists of correspondence.
• Assist in preparation of documents including regulatory document templates, study binders, study communications and presentations.
• Manage clinical, regulatory, and study-related essential documents such as study protocols, Informed Consent Forms, etc.
• Assist with all aspects of initial study drug release including regulatory packet review and study-drug release.
• Assist in the preparation and development of study-specific training materials.
• Participate in the planning of investigator meetings.
• Interact with sites as needed to respond to issues.
• Handle incoming and outgoing shipments, as needed.
• Monitor and track monitoring visit reports.
• Collect enrollment updates and reports on a weekly basis.
• Assist PM with set up and preparation of project meetings.

CRO – Clinical Trials Assistant

Clinical Research

• Assume primary accountability for assigned clinical research projects and ensures compliance with applicable regulations, guidelines, and corporate policies for study activities.
• Manage and execute the overall project scope, budget, and timelines.
• Identify project success factors for analysis, reporting, and tracking.
• Manage resources and timelines associated with all study start-up and implementation activities.
• Lead the development of study specific protocols, consent forms, and other trial related materials as required.
• Ensure the appropriate development of study documents including, but not limited to, study plans, case report form instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies.
• Participate in the review of clinical data for analysis.
• Ensure that all project tasks meet client expectations and are completed in accordance with the contract, trial protocol, and Standard Operating Procedures (SOPs).
• Serve as a liaison between clients and internal team to ensure project specific information and ongoing updates are proactively communicated.
• Plan for and manage all materials to support the appropriate execution of the clinical projects, including but not limited to distribution of documents, forms, supplies, equipment, and investigational devices.
• Monitor adherence to project contract and budget.
• Coordinate with clinical, business development, and operations management to identify goals and scope of clinical study projects.
• Ensure operational and regulatory integrity of assigned studies and participate in FDA or other regulatory authority inspections, as needed.
• Support the management and oversight of clinical study related vendors.
• Review site monitoring reports ensuring finalization as required by SOP and/or client contractual requirements.
• Enhance department and organization reputation by participating in departmental or corporate initiatives.
• Update job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
• Attend off-site meetings and conferences, as needed.

Clinical Research Project Manager

• Primary responsibilities include medical and safety oversight of clinical trials
• Provides services to clinical trials with the aim to monitor the safety and wellbeing of study participants
• Ensure integrity of the project data in accordance with clinical trial protocols, SOPs, GCP, and regulatory requirements
• Perform in-depth medical assessment of key study information through review of the protocol, Investigator Brochure, Informed Consent Form, and appropriate literature
• Provide medical input for protocol design, as appropriate
• Participate in Site Initiation Visits and/or Investigator Meetings
• Provide 24/7 medical consultancy support to investigators and study team
• Prepare and/or review the Medical Monitoring Plan, as well as the Safety Management Plan and related study documents
• Support the clinical team for subject selection regarding interpretation and application of the protocol inclusion and exclusion criteria
• Follow study status via email, phone calls, and participation in team meetings
• Participate in safety review meetings per protocol
• Perform review of Serious Adverse Events (SAE) reported by sites to assess medical contents and case completeness
• Collaborate with site staff, Lotus team members and sponsor staff to finalize each event
• Develop and/or SAE narratives and MedWatch reports
• Review protocol deviations and classify according to agreed criteria
• Provide support for the clinical team regarding early discontinuation of treatment and end of study assessments
• Provide review of adverse events, concomitant medications and medical history to assess overall risks to subject safety
• Provide Medical review of other study data such as laboratory results, ECGs, etc. per the scope of work
• Provide review and comment on the Clinical Study Report regarding overall study conduct and safety data

CRO – Clinical Trials Assistant

Clinical Research Project Manager

Contract Medical Monitor, Psychiatrist