Centralized Study Spec I New
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Log in to apply• Review and implementation of relevant study-specific plans that describe the required expectations for assigned tasks
About the role
Summary of Responsibilities:
• Review and implementation of relevant study-specific plans that describe the required expectations for assigned tasks
• Support system compliance and system data entry, as applicable
• File required task-related documentation in the Electronic Trial Master File (eTMF)
• Review initial/amended Country/Site ICFs in compliance with Sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines.
• Liaising and follow-up with local teams, Start-up Project Managers, and Sponsors to assure timely approval of Informed Consent Forms in order to meet submission deadlines.
To follow all applicable departmental Standard Operating Procedures and Work Instructions:
• To complete required trainings according to required timelines.
• To complete day-to-day tasks ensuring quality and productivity.
• To manage project and technical documentation in an appropriate manner.
• To provide administrative and technical support to internal departments and teams as needed.
• To perform checks to ensure quality of work completed.
• To ensure timely escalation and issue resolution as needed.
• To participate in process improvement opportunities and assist with the implementation of revised processes and procedures.
• All other duties as needed or assigned.
Qualifications (Minimum Required):
• University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements
Experience (Minimum Required):
• Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines.
• 3-5 years' work experience in clinical research
• Previous interaction with operational project teams preferred.
Preferred Qualifications Include:
• Computer proficiency in MS Office (Word, Excel, PowerPoint, Access, Outlook e-mail and internet services)
• Good written and oral communication skills
• Well-developed organizational skills
• Excellent proof-reading skills
Physical Demands/Work Environment:
• General Office Environment.
Learn more about our EEO & Accommodations request here.
• Review and implementation of relevant study-specific plans that describe the required expectations for assigned tasks
• Support system compliance and system data entry, as applicable
• File required task-related documentation in the Electronic Trial Master File (eTMF)
• Review initial/amended Country/Site ICFs in compliance with Sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines.
• Liaising and follow-up with local teams, Start-up Project Managers, and Sponsors to assure timely approval of Informed Consent Forms in order to meet submission deadlines.
To follow all applicable departmental Standard Operating Procedures and Work Instructions:
• To complete required trainings according to required timelines.
• To complete day-to-day tasks ensuring quality and productivity.
• To manage project and technical documentation in an appropriate manner.
• To provide administrative and technical support to internal departments and teams as needed.
• To perform checks to ensure quality of work completed.
• To ensure timely escalation and issue resolution as needed.
• To participate in process improvement opportunities and assist with the implementation of revised processes and procedures.
• All other duties as needed or assigned.
Qualifications (Minimum Required):
• University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements
Experience (Minimum Required):
• Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines.
• 3-5 years' work experience in clinical research
• Previous interaction with operational project teams preferred.
Preferred Qualifications Include:
• Computer proficiency in MS Office (Word, Excel, PowerPoint, Access, Outlook e-mail and internet services)
• Good written and oral communication skills
• Well-developed organizational skills
• Excellent proof-reading skills
Physical Demands/Work Environment:
• General Office Environment.
Learn more about our EEO & Accommodations request here.
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