[Hiring] Associate Director, Study Start Up @Codera

Role Description

The Associate Director, Study Start Up & Records Management is responsible for assisting the study team by performing tasks related to study start-up, study/site management, clinical operations, inspection readiness and IRB/EC submissions of Aurinia’s clinical trials according to Standard Operating Procedures (SOPs), ICH-GCP guidelines and all applicable regulatory requirements. The Associate Director will interface with Site Directors and the study team to support operational aspects of study start-up and execution.

Primary Responsibilities

• Support the execution of Phase I-IV studies including study start-up, site management and clinical operations activities in compliance with 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.

Qualifications

• 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.

Requirements

• The job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required. They may change, or new ones may be assigned at any time with or without notice.

Benefits

• Comprehensive benefits package designed to support employees’ physical, mental and financial health.
• Employer sponsored insurance plans including medical, dental and vision coverage.
• Generous paid time off.
• Retirement plan options.
• Additional wellness and professional development programs.