Sr. Project Coordinator II - FSP - Oncology

Durham - USA

Monthly Salary: $ 80000 - 92000

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Job Overview:

Coordinates the activities associated with the evaluation initiation and management of clinical trials. Manages clinical studies including CRO oversight. Coordinates the training of staff involved in trial management. coordinates day-to-day operational execution of clinical trials including the daily management activities relating to the Trial Master Files (TMF) including ensuring regulatory inspection-readiness and compliance with applicable laws and regulations. This role also supports the filing quality control and management of expected documents in eTMF.

Summary of Responsibilities:

Develop plans to manage clinical trials determine operational risks and develop and mitigation plans to address risks proactively
Perform CRO oversight activities such as Trip Report Review TMF review and co-monitoring visits per Study Plans. Provide written documentation of all activities including issues and findings in Spreadsheets or databases
Knowledge of the TMF Reference Model in order to utilize the TMF Master Index as the source of reference for filing documents in eTMF
Responsible for ensuring any missing documents in eTMF are addressed and reconciled if necessary
Co-monitor clinical study sites; write and review reports for PSSVs SIVs IMVs and COVs as required
Assist in the management of external vendors (e.g. clinical labs study assessment labs)
Responsible for study start- up activities and tracking study metrics (e.g. ICF review Investigator/site performance recruitment regulatory documents and CRO TMF catalog); track study metrics such as site start-up Investigator/site performance recruitment regulatory documents CRO TMF catalog
Maintain internal document management system (e.g. Livelink) and TMF ensuring important documents and communication filed timely and appropriately
Assist with protocol- and study-specific training with vendor(s) site personnel and clinical sites
Review template informed consents and monitoring visit reports for completeness and accuracy and adherence to the protocol
Coordinate clinical drug / supply reconciliation with oversight of site and CRA reconciliation
May conduct data listing review of CRF data for safety thoroughness and data preparation for final study reports
Review and/or create study document (e.g. newsletters worksheets study trackers)
Assist in the coordination of study team management meetings prepare agenda draft 2 and finalize minutes and track action items to completion
Working knowledge of clinical trial databases (e.g. EDC CTMS eTMF) and interactive response technologies (e.g. IWRS IXRS) including report generation
Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines local regulatory requirements SOPs and study specific procedures

Qualifications (Minimum Required):

University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing medical or laboratory technology) from appropriately accredited institution
Fortrea may consider relevant and equivalent experience in lieu of educational requirements

Experience (Minimum Required):

4-5 years of relevant clinical research experience in a pharmaceutical company/CRO.
Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
Advanced computer skills (e.g. Microsoft Word Excel Project Access and Power Point)
Ability to develop accurate study related documents with minimal supervision.
Good verbal and written communication skills.
Ability to mentor junior staff.
Ability to resolve project-related problems and prioritize workload for self.
Demonstrated organizational skills and the ability to prioritize multi-tasks.
Ability to work with financial information.
Basic knowledge of project management processes
Up to 25% travel

Pay Range:$ USD annually

Benefits: All job offers will bebased on a candidates skills and prior relevant experience applicable degrees/certifications as well as internal equity and market full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical Dental Vision Life STD/LTD 401(K) ESPP Paid time off (PTO) or Flexible time off (FTO) Company bonus where applicable. For more detailed information pleaseclick here.

Applications will be accepted on an ongoing basis.

Learn more about our EEO & Accommodations request here.

Required Experience:

Senior IC

Fortreas FSP team is hiring experienced Sr. Project Coordinators with prior CRO experience! 3 years of PC experience preferred. Oncology experience highly desired. Ability to work some West Coast hours is ideal. Job Overview:Coordinates the activities associated with the evaluation initiation and ma...

Job Overview:

Summary of Responsibilities:

Develop plans to manage clinical trials determine operational risks and develop and mitigation plans to address risks proactively
Perform CRO oversight activities such as Trip Report Review TMF review and co-monitoring visits per Study Plans. Provide written documentation of all activities including issues and findings in Spreadsheets or databases
Knowledge of the TMF Reference Model in order to utilize the TMF Master Index as the source of reference for filing documents in eTMF
Responsible for ensuring any missing documents in eTMF are addressed and reconciled if necessary
Co-monitor clinical study sites; write and review reports for PSSVs SIVs IMVs and COVs as required
Assist in the management of external vendors (e.g. clinical labs study assessment labs)
Responsible for study start- up activities and tracking study metrics (e.g. ICF review Investigator/site performance recruitment regulatory documents and CRO TMF catalog); track study metrics such as site start-up Investigator/site performance recruitment regulatory documents CRO TMF catalog
Maintain internal document management system (e.g. Livelink) and TMF ensuring important documents and communication filed timely and appropriately
Assist with protocol- and study-specific training with vendor(s) site personnel and clinical sites
Review template informed consents and monitoring visit reports for completeness and accuracy and adherence to the protocol
Coordinate clinical drug / supply reconciliation with oversight of site and CRA reconciliation
May conduct data listing review of CRF data for safety thoroughness and data preparation for final study reports
Review and/or create study document (e.g. newsletters worksheets study trackers)
Assist in the coordination of study team management meetings prepare agenda draft 2 and finalize minutes and track action items to completion
Working knowledge of clinical trial databases (e.g. EDC CTMS eTMF) and interactive response technologies (e.g. IWRS IXRS) including report generation
Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines local regulatory requirements SOPs and study specific procedures

Qualifications (Minimum Required):

University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing medical or laboratory technology) from appropriately accredited institution
Fortrea may consider relevant and equivalent experience in lieu of educational requirements

Experience (Minimum Required):

4-5 years of relevant clinical research experience in a pharmaceutical company/CRO.
Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
Advanced computer skills (e.g. Microsoft Word Excel Project Access and Power Point)
Ability to develop accurate study related documents with minimal supervision.
Good verbal and written communication skills.
Ability to mentor junior staff.
Ability to resolve project-related problems and prioritize workload for self.
Demonstrated organizational skills and the ability to prioritize multi-tasks.
Ability to work with financial information.
Basic knowledge of project management processes
Up to 25% travel