Study Start-up Lead at Alliance For MultiSpecialty Research LLC

, , United States -

Full Time

Start Date

Immediate

Expiry Date

21 Jan, 26

Salary

0.0

Posted On

23 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Study Start-Up, Regulatory Compliance, Project Management, Communication Skills, Organizational Skills, Attention to Detail, Task Management, Prioritization, Initiative, Adaptability, Team Collaboration, Veeva Vault, GCP, ICH Guidelines, FDA Regulations, Stakeholder Management

Industry

Biotechnology Research

Description

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. Classification: Exempt Position: REMOTE Primary Responsibilities include but not limited to: * 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. Desired Skills and Qualifications: * Bachelor’s Degree preferred * Minimum 3 years of experience in a Clinical Study Start-up role. * Minimum 3 years of regulatory experience (start-up regulatory experience is preferred) * 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, as this is a lead start-up position. * 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. * 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. AMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor. ** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.

Responsibilities

The Study Start-up Lead manages and coordinates start-up and regulatory activities for AMR research sites, ensuring compliance with FDA regulations and AMR’s SOP. This role serves as the primary point of contact for all study start-up activities, facilitating communication between stakeholders and ensuring timely enrollment readiness.