ResearchEd

Project Manager

• Responsible for planning, tracking and delivery of efficient and high-quality trial execution of all operational aspects of assigned clinical trials/programs
• Responsible to manage and drive the SOW consistent with the targeted timelines and budget for the assigned clinical trials/programs
• Ensure the completion of all project deliverables from contract signature to delivery of final clinical study report
• Lead cross-functional teams while understanding and managing client expectations
• Monitor and QC the electronic Trial Master File (eTMF) to ensure that the required trial documentation is filed

Senior Project Manager

Research Analyst

• Monitor clinical trials according to monitoring plans to achieve project goals
• Conduct or assist with site evaluations, study initiations, routine monitoring and site close-outs
• Work with the study start up team and site staff to obtain regulatory (IRB/IEC) approval of study specific documents
• Perform data review activities, collaborate with data management to identify trends
• Ensure study documentation is maintained in the Investigator Study File
• Document accountability, stability and storage conditions of clinical trial materials
• Communicate with site study staff and Catalyst Clinical Research LLC clinical research personnel
• Proactively manage site issues and incorporate a root cause analysis and corrective action plan

Senior Clinical Research Associate

• Accountable for achieving successful delivery of clinical trial team activities at the trial/program level.
• Leads and directs cross functional teams.
• Proactively identifies, resolves/mitigates, and escalates risks and/or issues.
• Responsible for planning, tracking and delivery of efficient and high-quality trial execution of all operational aspects of assigned clinical trials/programs.
• Manages study vendors, patient enrollment and liaises with investigators and study sites.
• Communicates to the sponsor with strict attention to budget and timeline estimates.
• Ensures the completion of all project deliverables from contract signature to delivery of final clinical study report.
• Collaborates with internal safety team member to develop Safety Management Plan.
• Monitors quality of vendor deliverables and addresses any issues.

• Monitor clinical trials according to monitoring plans to achieve project goals
• Conduct or assist with site evaluations, study initiations, routine monitoring and site close-outs
• Work with the study start up team and site staff to obtain regulatory approval of study specific documents
• Perform data review activities, collaborate with data management to identify trends and implement corrective action to enhance data quality
• Ensure compliance with appropriate regulations and guidelines throughout the trial
• Participate in project audit/inspection preparation and conduct

Manager

• Is primarily responsible for the identification and activation of clinical sites and acting as the study functional lead for the Central Site Services team.
• Works directly with the Project Manager, Clients, Vendors, and other internal functional teams to ensure quality deliverables on-time and on-budget.
• Participates in hand over meeting from feasibility team member.
• Coordinates site identification tasks including but not limited to Site Feasibility Questionnaires (SFQs). development/distribution/collection/analysis, and confidentiality agreement (CDA) negotiation and execution.
• Develops site activation timeline.
• Works with the study team to determine the Essential Document Package (EDP) requirements.
• Completes templated documents with study specific information.
• Coordinates and distributes the EDP to the clinical sites.
• Tracks site identification and activation progress, identifies operations issues and escalates issues to the attention of the Project Manager.
• Inputs study timelines and other required fields into the tracking system, monitors and updates fields as study timelines or other information changes.
• Develops and maintains the site start up plan.
• Assists with the development and maintenance of clinical study plans.

Senior Project Manager

Senior Clinical Research Associate

Project Manager

Senior Clinical Research Associate

Senior Site Activation Manager