Study Start-up Lead

Alliance For MultiSpecialty Research LLC

108d

About The Position

The Study Start-up Lead is responsible for managing and coordinating start-up and regulatory activities for AMR research sites. This role is responsible for ensuring complete and accurate performance of study regulatory and start-up activities in compliance with the Food and Drug Administration (FDA) regulations and AMR’s SOP. To consistently embody AMR Clinical’s Core Values: United We Achieve, Celebrate Diverse Perspectives, Do the Right Thing, Adapt and Persevere. The Study Start-up Lead reports to the Study Start-Up Manager and V.P. of Project Management.

Requirements

• Bachelor’s Degree preferred.
• Minimum 3 years of experience in a Clinical Study Start-up role.
• Successful candidates will be expected to be experts in study start-ups, with the ability to lead/drive all aspects of study start-up and be the main point of contact for Sponsors/CRO’s and other Stakeholders.
• Veeva Vault experience is preferred.
• Strong verbal and written communication skills, organizational skills, project management skills, and attention to detail.
• Excellent task management, prioritization, and follow-up skills.
• Ability to work independently and demonstrate initiative and discretion.
• Ability to multi-task and perform multiple critical tasks simultaneously.
• Ability to adapt to changing environments and new processes.
• Basic knowledge of computer software in a variety of programs, i.e. Word, Excel, PowerPoint, etc.
• Positive, collaborative, and team oriented.
• Self-driven and goal oriented.
• Ability to work in a fast-paced environment.
• Strong understanding and adherence to standard operating procedures, regulatory, FDA regulations, and GCP and ICH guidelines.

Responsibilities

• Performing work that significantly affects business operations by managing all study regulatory and start-up activities for AMR Sites from Site Selection to Site Activation, in compliance with Sponsor/CRO requirements, ICH and GCP, relevant regulations, and AMR’s SOP.
• Ensures a quick, efficient start-up to achieve enrollment readiness in adherence to the study’s timeline.
• Primary point of contact for all study start-up activities, including Regulatory Document Completion, IRB Submission, Essential Document Completion, Vendor/Portal Access, Training, and Supplies.
• Develops and maintains strong relationships with Stakeholders, including CROs, Sponsors, and internal AMR teams.
• Coordinates communication between the Sponsor/CRO and relevant AMR Staff.
• Submits vendor access requests and ensures timely receipt of vendor/portal access and training for applicable staff.
• Consistently communicates with site staff to confirm portal access, training completion, and receipt of study supplies.
• Coordinates setup of Local Labs.
• Attends internal and external study meetings to discuss study timelines, procedures, and start-up progress.
• Prepares and Leads Strategic Planning Meetings with AMR Teams to ensure cohesive communication and enrollment readiness for studies at participating AMR Sites.
• Maintains Study Launch Dashboard and Clinical Conductor Enterprise (CCE) to track start-up progress and reports start-up metrics (e.g. Award Date, IRB Document Receipt and Completion Date, IRB Submission, IRB Approval, SIV Date, Site Activation Date, etc.).
• Works with Study Start-Up Manager and Project Manager on special projects when needed.

Benefits

• Work Hours: 40 hours a week, Monday – Friday. Work can include 'non-standard' hours.
• Typical Mental Demands: Required to manage multiple tasks and adhere to strict study protocol and regulatory and compliance requirements and company standard operating procedures and policies.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree