Job Description:
• 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.
Requirements:
• Bachelor’s Degree with minimum 5 years of relevant clinical trial experience required
• Minimum 3 years of feasibility and study start-up experience
• Experience and proven proficiency in CTMS and eTMF systems
• Experience with Veeva Systems preferred
• General knowledge of clinical site monitoring, feasibility and study start-up preferred
• Detail-oriented, organized, and committed to quality and consistency
• Results-driven and capable of managing competing high-priority assignments with a proven track record of achieving deliverables within specified timelines
• Excellent team-interaction skills and ability to work successfully in global team settings
• Ability to work in a dynamic environment with a high degree of flexibility
• Possess a willingness and ability to work hands-on and with a sense of urgency in a fast-paced, entrepreneurial environment
• Must be proficient in Microsoft Word, Excel, and PowerPoint.
Benefits:
• employer sponsored insurance plans including medical, dental and vision coverage
• generous paid time off
• retirement plan options
• additional wellness and professional development programs