Codera

Research Analyst

• Responsible for the successful start-up, monitoring and execution of Phase I-IV studies at assigned clinical sites
• Perform clinical site management and monitoring activities in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines
• Serve as primary point of contact for clinical sites through all phases from start-up to close-out of clinical studies
• Arrange for monitoring availability and ensure data entry timelines are maintained at assigned sites
• Perform required monitoring, including required source data verification, and ensure site activities are conducted in established timelines
• Develop and cultivate strong site relationships and ensure continuity of site relationships
• Communicate with investigators and site staff on issues related to protocol conduct, recruitment, protocol deviations, inspection readiness and overall site performance
• Identify, assess, escalate and resolve site performance or quality issues in a timely manner
• Complete feasibility and site identification activities for new clinical studies
• Conduct start-up and maintenance activities for designated sites including preparation and collection of essential documents required for regulatory and IRB/EC submission (initial and amendments)
• Facilitate communication with appropriate site staff involved in start-up and IRB/EC submissions
• Facilitate site budget and site contract negotiations and ensure timely finalization of the required clinical trial agreements for designated sites in collaboration with clinical program management and finance
• Responsible for the development of site-specific recruitment, retention and follow-up plans
• Facilitate and support investigator site audits and/or inspection activities as needed
• Perform remote data review and query resolution for designated sites
• Contribute to overall clinical operations team knowledge by sharing best practices and participating in improvement initiatives
• Coach and mentor colleagues as needed
• Contribute to the review of Codera’s systems and procedures as needed
• May be involved, when needed, in other areas of study management and staff training
• Execute other duties as assigned

Clinical Research Associate – Site Director

Manager

• Provide support for TMF activities by ensuring documents uploaded to the TMF adhere to Standard Operating Procedures, ICH GCP guidelines and other regulatory requirements
• Act as a TMF Subject Matter Expert (SME) and work with the study teams to ensure the TMFs and CTMS for clinical studies are inspection ready at all times
• Review study documents received from the study teams for completeness and accuracy and upload to the Trial Master File (TMF)
• Perform quality control of documents submitted to the TMF per SOPs, Work Instructions and Guidance Documents
• Ensure documents which fail TMF quality control and/or TMF quality review are effectively remediated and provide best practice recommendations, as needed
• Conduct TMF educational workshops/training, as needed
• Address TMF questions pertaining to how documents are filed, and user questions related to the TMF system
• Ensure Essential Document Lists (EDLs) are maintained on an ongoing basis
• Perform the secondary review of site Essential Document Packages per applicable SOPs to ensure sites meet the requirements for site activation and Investigational Product (IP) release
• Responsible for Clinical Trial Management System (CTMS) maintenance, including study, country and site level updates and reviewing CTMS entries for accuracy
• Contribute to TMF QC Tools as needed to match with evolving business processes (incl. QC Tool, QC Manual, Doc Owner Manual, TMF Newsletters)
• Maintain up to date knowledge of the TMF Reference Model, industry best practices and regulatory considerations as applicable to the job duties
• Assist with inspection/audit related activities (e.g., preparation, corrective action plans)

Manager, Records Management – TMF Quality Control Specialist

Director

• Support the execution of Phase I-IV studies including study start-up, site management and clinical operations activities in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s) and applicable study plans.
• Prepare and manage potential Investigator site lists, perform site outreach, assist in identifying clinical trial sites and contribute to site feasibility and site selection decisions.
• Act as main contact for study sites during start-up, including communicating with investigators and site staff on issues related to feasibility, essential document collection and IRB submissions.
• Support study start-up activities including the review of feasibility questionnaires, facilitation of site selection internal approvals, review of and facilitation of ICF internal approvals, and the completion of Investigator background checks.
• Prepare and review study documents (e.g., essential document packets, study plans, site Informed Consent Forms (ICFs), etc.) to ensure quality and consistency.
• Distribute and follow-up on start-up documents with sites.
• Review returned documents from the sites to ensure quality and completeness.
• Review and approve Essential Document Packages for site activation.
• Responsible for oversight of the central IRB in the United States/Canada.
• Prepare and submit required study documents to central IRB.
• Support central IRB annual reviews and study updates.
• Communicate with central IRB as needed.
• Support site IRB annual reports and updates, as needed.
• Assist with the facilitation of the site contract and budget process.
• Manage translation of necessary documents through translation vendor.
• Support creation of and updates to study translation plan.
• Support setup and management of Clinical Operations vendors (e.g. rater training, home healthcare). Facilitate and track vendor system access requests.
• Assist in Clinical Trial Management System (CTMS) maintenance including entry of study and site level updates, assistance with running reports and reviewing CTMS entry accuracy.
• Review study documents received from the study team for completeness and accuracy and upload to the Trial Master File (TMF).
• Assist with TMF quality reviews to ensure completeness, accuracy and timeliness of study documents to ensure TMFs are inspection ready at all times.
• Assist with oversight of study site training.
• Support inspection preparedness and study/site audit and/or inspection activities, as needed.
• Execute other duties as assigned.

Associate Director, Study Start Up

Program Manager

• Support CPM Leads with operational tasks and overall conduct of clinical studies
• Manage study operational plan, including project timelines, budget, and quality of deliverables, throughout the duration of the assigned clinical studies
• Partner closely with Aurinia functional areas to ensure delivery of all study and site goals (e.g., start-up, enrollment, data flow, quality, etc.)
• Monitor study progress against plan; develop and implement operational risk management plans
• Participate in the selection of study vendors
• Responsible for vendor set up from selection through study close-out
• Management of site and vendor-related issues to resolution
• Responsible for vendor engagement and oversight, maintaining frequent contact and oversight of applicable vendors to assess performance and provide guidance as needed
• Participate in the selection of investigational sites
• Oversee protocol deviation and risk management reviews
• Manage study-specific team training per study plans and procedures
• Provide input in the development of department processes, procedures, and guidelines, as required
• May provide or facilitate training of clinical study teams on assigned protocol specific topics
• Liaise with all internal and external team members and stakeholders to facilitate achievement of study goals
• Contribute to the creation and finalization of relevant study documentation by providing operational input into protocol design, clinical study reports as well as other operational plans (monitoring plan, data management plan, etc.)
• Work proactively to ensure alignment on data flow and timely delivery of data; may participate in study data review and other review activities as necessary
• Provide ongoing assessment of subject enrollment/discontinuations to inform accurate forecasting and planning
• Ensure the submission of trial-related and essential documents to the Trial Master File (TMF)
• Support submission activities, as necessary
• Develop and provide key input to the Clinical Trial Budget (e.g., per subject costing)
• Review and approve informed consent form (ICF) and study/country/site level ICFs as appropriate
• Support with alliance management, as needed
• Serve as a resource to facilitate audit/inspections, as applicable

Associate Director, Clinical Program Management

Supply Chain

• Serve as the primary clinical supply chain contact
• Provide study and site-level support (e.g., resupply requests, return and destruction management, temperature excursion management)
• Manage drug supply shipments
• Facilitate and oversee storage, returns, reconciliation and destruction
• Monitor inventory levels, drug product expirations and resupplies
• Oversee import/export licenses and customs forms
• Develop and execute global inventory supply plans in coordination with Technical Operations, Clinical Operations and Quality Assurance
• Ensure batch release dates are properly prioritized for key study timelines
• Onboard and manage relationships with clinical supply chain vendors, including negotiating and reviewing agreements, resolving issues and providing financial oversight
• Prepare and manage clinical supply projections
• Maintain budget for supply chain operations and review and track monthly invoices from vendors against budget
• Create and maintain supply chain-related Standard Operating Procedures (SOPs) and associated Forms and Plans
• Ensure clinical supply documentation is organized and filed to the Trial Master File (TMF), per SOPs
• Ensure supply chain compliance with GxP documentation and training requirements
• Participate in inspection readiness efforts, ensuring clinical supply chain is prepared for both internal and external audits
• Review and approve packaging and labeling documents and batch records
• Draft vendor documentation required for receipt/shipment of clinical supplies and investigational product
• Assist in the design, build and user acceptance testing of IRT system
• Execute other duties as assigned

Director, Clinical Supply Chain

Vice President

• Oversee clinical development programs including strategic planning and execution of clinical trials
• Evaluate and refine development strategies to mitigate risks and expedite the advancement of assets
• Direct the planning, delivery and leadership of clinical trials from early to late phases
• Lead the development and refinement of clinical trial protocols, ensuring scientific rigor, ethical considerations and compliance with regulatory guidelines
• Assume medical and clinical accountability throughout the clinical trial lifecycle, including safety monitoring, data interpretation and risk management
• Oversee biometrics and medical writing to ensure all clinical and nonclinical studies are designed, analyzed and summarized appropriately in accordance with timelines, good quality practices and applicable regulatory requirements
• Collaborate with the Vice President, Regulatory Affairs in the development and execution of regulatory strategies to facilitate successful clinical trial approvals and submissions
• Direct data analysis and reporting activities, providing strategic insights to support decision-making and regulatory submissions

Vice President, Clinical Development

• Responsible for the successful start-up, monitoring and execution of Phase I-IV studies at assigned clinical sites
• Perform clinical site management and monitoring activities in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines
• Serve as primary point of contact for clinical sites through all phases from start-up to close-out of clinical studies
• Arrange for monitoring availability and ensure data entry timelines are maintained at assigned sites
• Perform required monitoring, including required source data verification, and ensure site activities are conducted in established timelines
• Develop and cultivate strong site relationships and ensure continuity of site relationships
• Communicate with investigators and site staff on issues related to protocol conduct, recruitment, protocol deviations, inspection readiness and overall site performance
• Identify, assess, escalate and resolve site performance or quality issues in a timely manner
• Complete feasibility and site identification activities for new clinical studies
• Conduct start-up and maintenance activities for designated sites including preparation and collection of essential documents required for regulatory and IRB/EC submission (initial and amendments)
• Facilitate communication with appropriate site staff involved in start-up and IRB/EC submissions
• Facilitate site budget and site contract negotiations and ensure timely finalization of the required clinical trial agreements for designated sites in collaboration with clinical program management and finance
• Responsible for the development of site specific recruitment, retention and follow-up plans
• Facilitate and support investigator site audits and/or inspection activities as needed
• Perform remote data review and query resolution for designated sites
• Contribute to overall clinical operations team knowledge by sharing best practices and participating in improvement initiatives
• Coach and mentor colleagues as needed
• Contribute to the review of Codera’s systems and procedures as needed
• May be involved, when needed, in other areas of study management and staff training
• Execute other duties as assigned

Clinical Research Associate – Site Director

Clinical Research Associate – Site Director

Manager, Records Management – TMF Quality Control Specialist

Associate Director, Study Start Up

Associate Director, Clinical Program Management

Director, Clinical Supply Chain

Vice President, Clinical Development

Clinical Research Associate, Site Director