Associate Director, Study Start Up

📋 Description

• Assist in the execution of Phase I-IV studies, encompassing study initiation, management of sites, and clinical operations activities, while adhering to ICH-GCP guidelines, SOPs, local laws and regulations, study protocols, and relevant study plans.

• Prepare and manage potential lists of Investigator sites, conduct outreach, aid in identifying clinical trial locations, and contribute to feasibility assessments and site selection processes.

• Serve as the primary contact for study sites during the initiation phase, including communication with investigators and site personnel regarding feasibility, collection of essential documents, and submissions to the IRB.

• Assist in study initiation tasks, such as reviewing feasibility questionnaires, facilitating internal approvals for site selection, reviewing and facilitating internal approvals for Informed Consent Forms (ICFs), and completing background checks for Investigators.

• Draft and review study documentation (e.g., essential document packets, study plans, site ICFs, etc.) to ensure high standards of quality and consistency.

• Distribute and follow up on initiation documents with sites.

• Review returned documentation from sites to verify quality and completeness.

• Review and approve Essential Document Packages for site activation.

• Oversee the central IRB in the United States and Canada.

• Prepare and submit necessary study documents to the central IRB.

• Assist with annual reviews and updates for the central IRB.

• Communicate with the central IRB as required.

• Assist with annual reports and updates for site IRBs, as necessary.

• Help facilitate the process of site contracts and budgets.

• Manage the translation of essential documents through a translation vendor.

• Aid in the creation and updates of the study translation plan.

• Support the setup and management of Clinical Operations vendors (e.g., rater training, home healthcare) and facilitate tracking of vendor system access requests.

• Assist with maintenance of the Clinical Trial Management System (CTMS), including entry of updates at both study and site levels, generating reports, and ensuring accuracy in CTMS entries.

• Review study documents from the study team for completeness and accuracy, and upload them to the Trial Master File (TMF).

• Assist with quality reviews of the TMF to confirm the completeness, accuracy, and timeliness of study documents, ensuring readiness for inspections at all times.

• Help oversee training for study sites.

• Support preparation for inspections and activities related to study/site audits and/or inspections, as required.

• Perform other duties as assigned.

⛳️ Requirements

• Bachelor's Degree with at least 5 years of relevant experience in clinical trials is required.

• A minimum of 3 years of experience in feasibility and study initiation is necessary.

• Proven experience and proficiency in CTMS and eTMF systems are required.

• Experience with Veeva Systems is preferred.

• General knowledge of clinical site monitoring, feasibility, and study initiation is preferred.

• Must be detail-oriented, organized, and committed to maintaining quality and consistency.

• Results-oriented and capable of managing multiple high-priority tasks with a demonstrated ability to meet deadlines.

• Excellent teamwork skills and ability to work effectively in global team environments.

• Must be adaptable to a dynamic work environment with a high level of flexibility.

• Willingness and capability to work hands-on with a sense of urgency in a fast-paced, entrepreneurial setting is essential.

• Proficiency in Microsoft Word, Excel, and PowerPoint is required.

🏝️ Benefits

• Employer-sponsored insurance plans, including medical, dental, and vision coverage.

• Generous paid time off.

• Retirement plan options.

• Additional wellness and professional development programs.