Research Analyst

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Performs remote and on-site monitoring & oversight activities using various tools to ensure Data generated at site are complete, accurate and unbiased and subjects’ right, safety and well-being are protected.
• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA-Manager, CRM, TA Head and CRD as needed.
• Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
• Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
• Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.
• Supports and/or leads audit/inspection activities as needed.
• Performs co-monitoring visits where appropriate.
• Following the country strategy defined by CRD and/or CRA-Manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.

Clinical Research Associate, Oncology

• Develop clinical trial budgets, including review of protocols and relevant documents to ensure that appropriate costs and allocation of institutional resources are fully captured in the budget.
• Work in collaboration with ancillary teams, departments, investigators, research staff, supporting administration, and sponsors/funding agencies to create complete, comprehensive, accurate and timely budgets.
• Ensure appropriate research rates are applied to study budgets.
• Independently develop, negotiate, and finalize budgets of moderate complexity with sponsors, academic sites, and other extramural funding sources to reach an agreement on budget and payment terms.
• Submit and maintain the budget and other financial information into OnCore Clinical Trial Management System (CTMS) to maintain proper reimbursement and revenue integrity.
• Perform pre-award quality assurance to verify completion of required elements prior to Medicare Coverage Analysis.
• Communicate and meet with stakeholders to facilitate ongoing budget discussions and provide updates to relevant parties.
• Use advancing knowledge to develop and disseminate clinical research education as needed in accordance with federal regulations, institutional policies, and specific protocol requirements.
• Apply knowledge of clinical research to provide recommendations and direction to clinical research teams to ensure budgetary compliance throughout all phases of the Clinical Trial Financials Lifecycle.
• Develop and support the formulation of program policies, procedures, and resources to establish and enhance clinical trial financials workflows.
• Provide excellent customer service while maintaining accurate results in a fast-paced, deadline-driven team environment.
• Engage in special projects and ad hoc duties as a member of the administrative team.

Clinical Trials Budget Specialist II

• Translates business requirements into business solutions;
• Acts as liaison between departmental leaders, staff and information technology staff to design and configure business solutions to ensure business requirements have been met.
• Works closely with stakeholders to define business requirements and with technical staff to develop solution alternatives and actively participates in defining objectives to support changing business needs and availability.
• Coordinates IT troubleshooting and day to day activities within the department to ensure seamless and minimal downtime of hardware, software and reporting requirements.
• May manage small to mid-sized projects/tasks and represent the department on larger enterprise-wide project teams.
• Creates and maintains project schedules by developing project plans and specifications, estimating time requirements, establishing deadlines, monitoring milestone completion, tracking all phases of the project product/service lifecycle, providing timely reporting of issues that impact project progress, coordinating actions, and resolving conflicts.
• Coordinates and conducts project team meetings regularly to review project deliverables and deadlines.
• Has knowledge and experience in the various techniques to elicit, analyze and communicate requirements within assigned functional areas.
• Establishes test plans, test cases and executes testing.
• Assists with end user training.
• Recommends information technology solutions to meet business needs and coordinates the planning, development, and implementation of these solutions.

Business Analyst II

• Serves as the liaison between University stakeholders and companies, major foundations and non-profit entities, and government agencies.
• Manages the contract portfolio of departments and schools.
• Drafts and negotiates clinical research agreements, laboratory agreements, and other types of contracts.
• Advises faculty and staff on issues affecting contractual relationships.
• Reviews contract and agency guidelines to safeguard the interests of the university.
• Evaluates risk associated with transactions and agreements.
• Maintains electronic records that are consistent and current.

Contract Specialist – Office of the Vice Chancellor for Research

• Collaborate with team members to ensure all project deadlines are met and project logistics are accounted for
• Assist in all aspects of research across operational phases throughout the project, including survey proofing, data cleaning, data charting, data checking, recruitment updates, etc.
• Document client calls and internal meetings, including providing feedback to the relevant projects and ensuring documentation is shared with team for collaboration
• Support client deliverables by creating slides, identifying case studies, syndicated data and desk research that lend to the overall insights and narrative
• Manage logistical issues around fielding, data processing, vendors, etc., including identifying process improvements
• Proactively communicate availability/capacity/contributions to the team

Research Analyst jobs in Montana

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Clinical Research Associate, Oncology

Clinical Trials Budget Specialist II

Business Analyst II

Contract Specialist – Office of the Vice Chancellor for Research

Research Analyst – Custom Market Research