[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. Apply tot his job Apply To this Job