Clinical Study Associate I

Description:

• Assist in planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.

• Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).

• Reconcile the TMF document trackers generated by the CRO with the document archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.

• Distribute key study documents to the CRO and vendors as appropriate.

• Provide clinical administrative support to the study teams. This may include preparing meeting logistics, distributing agendas, and minutes for study team meeting, meetings with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings.

• Collect information and coordinate with DS Regulatory Operations to post trial information on required public forums (eg.clinicaltrials.gov).

• Support Fair Market Value process in evaluating study budgets

• Under supervision, review and document CRO-generated reports, such as site monitoring trip reports and protocol deviation reports and elevate issues to the attention of the supervisor.

• Compile and maintain a monitoring review spreadsheet.

• Compile and maintain CRO Oversight Monitoring (CROOM) visit output Track study metrics such as site start-up, Investigator/site performance, recruitment, regulatory documents, TMF filing and QC activities and elevate areas of concern to your supervisor.

• Create/maintain spreadsheets to track other items as needed, (e.g. Vendor invoices).

• Analyze study site metrics reports to identify potential areas of concern and bring to supervisor's attention.

Skills:

etmf, Clinical system, Clinical project management, cro, irb, clinical study, regulatory documents, clinical trial, sop, crf, Ctms, Sharepoint, Veeva, Edc, 1572, Meeting Minutes, Clinical research, Timeline, Document management, Clinical document, Vendor management, Clinical studies, Clinical documentation, Biotech, Pharmaceutical, Support, Pharma, Oncology, Regulatory, Filing, Site selection

Top Skills Details:

etmf,Clinical system,Clinical project management,cro,irb,clinical study,regulatory documents,clinical trial,sop,crf,Ctms,Sharepoint,Veeva,Edc,1572,Meeting Minutes

Additional Skills & Qualifications:

• Demonstrates knowledge of processes related to clinical studies, regulatory issues, assigned CRO operations, and compliance practices.

• Interacts appropriately with internal and external stakeholders (e.g., CROs and other team members).

• Demonstrates foundational knowledge and application of compliance practices.

• Effectively manages information, data, related analyses, forms and reports.

• Supports and effectively multi-tasks different assignments and responsibilities.

• Identifies and resolves problems when able to, escalates issues appropriately.

• Familiarity with medical terminology. Working skills in computer applications, such as Microsoft Word, Excel, PowerPoint, and Outlook.

• Basic oral and written communication skills Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO), and Contract Research Organization (CRO). Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant.

Education:

• A Bachelor's degree (preferred in Life Sciences) with relevant clinical development experience is acceptable.

Experience Level:

Entry Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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