Manager, Trial Execution Services: Greater Tampa or Greater Chicago area

Location: Greater Tampa or Greater Chicago area with home-based office – Must have access to a major airport. At times, may be required to be in office at the local research site.

Position Type: full-time, day and occasional evenings and weekends

Travel: 30-50% domestic travel, possibility of infrequent international travel

The Global Alzheimer’s Platform Foundation (GAP) is seeking a dependable and innovative Manager, Trial Execution Services, to lead recruitment and optimization strategies for assigned Alzheimer’s disease clinical trial sites in designated geographic region(s).

About the Global Alzheimer’s Platform Mission: A patient-centered, not-for-profit organization dedicated to speeding the delivery of innovative medicines to those in need by reducing the time and cost of Alzheimer’s and Parkinson’s disease clinical trials.

In 2017, the Global Alzheimer’s Platform Foundation (GAP) fully established GAP-Net, a growing network of >80 Alzheimer’s disease (AD) research centers committed to disrupting recruitment and study conduct processes to increase the speed and lower the cost of completing AD clinical trials. GAP-Net is unique in that GAP invited both academic and private sites deemed to be high performing AD sites with requisites that included data and best practices sharing, use of a central Institutional Review Board and common clinical trial contracts, and a commitment to the GAP mission. GAP is now leveraging our success in accelerating timelines on AD trials to create a new network

of research sites aiming to similarly increase the speed and delivery of PD Parkinson’s disease (PD) trials. GAP currently has nearly 30 PD trial sites across North America and are continuing to grow this network.

With GAP-Net active, AD and PD clinical trials and GAP programs and services are being deployed across North America with the ultimate goal to end Alzheimer’s sooner through accelerated research.

Job Summary

The Global Alzheimer’s Platform Foundation is seeking a Manager, Trial Execution Services. This position would be responsible for working directly with clinical trial sites that specialize in conducting Alzheimer’s disease and Parkinsons disease trials. Essential functions include:

Responsible for collaborating with assigned research sites in the GAP-Network geographic region(s) on recruitment and process optimization for specific Alzheimer’s and Parkinson’s disease clinical trials that will allow for the most productive and efficient practices at the site. Monthly, in-person or telephone visits to each assigned trial site will be required to provide material and practical support.

Partner with clinical trial sites to create and implement effective recruitment and outreach strategies and techniques for supported trials, ensuring that sites are engaged and regularly recruiting and screening participants for trials.

• Accountable for writing timely site visit reports for the study sponsor and/or contract research
• organizations (CROs) and providing consistent and immediate support to assigned research sites in order to help them maximize their productivity.
• Ability to navigate and have an in-depth understanding of complicated clinical trial protocols, and ability to develop exceptional tools to assist with recruitment, pre-screening, screening and retention of participants into trials.
• Responsible for helping to build communities of Alzheimer’s and Parkinson’s awareness in assigned
• geographic location(s) utilizing GAP’s novel recruitment model to garner understanding and support for AD and PD research.
• Providing strategic input on effective recruitment, outreach, and optimization strategies and assisting with the development of plans, tools and resources to carry-out the strategies.
• Facilitating sharing across GAP-Network research sites with regards to learnings and best practices by creating presentations or tools, speaking at conferences and/or webinars, and fielding requests for
• assistance and information on effective strategies for recruitment and optimization.
• Providing program and/or project management duties on large-scale projects. This could include but not be limited to: collecting data and metrics, organizing data in a presentable format via a dashboard, developing and leading team members around meeting specific goals and KPIs for the project, presenting to external clients, and managing the project budgets.
• Monitor GAP sponsored studies to ensure compliance with the study protocol, regulatory requirements, and Good Clinical Practice (GCP) guidelines. This would include regular reviews of trial activities at research sites, verifying the accuracy and completeness of study data, ensuring participant safety and informed consent procedures are properly followed, and identify and resolve any issues that could affect data quality or regulatory compliance with the participating sites. Documentation to be completed in a timely manner.
• Work closely with pharmaceutical and biotech companies, CROs and vendors in a collaborative, professional and highly effective manner.
• Providing input and assistance as needed with project proposals, reports, manuals, and other documents as needed.
• Experience with marketing strategies, social media, event or program management, community outreach, and/or public speaking are desirable but not required.
• May provide direct recruitment support at a local GAP-owned research site as needed, including staffing community events, educating healthcare providers (HCPs) and community members about clinical research opportunities, and implementing other outreach strategies to support participant recruitment and enrollment goals.
• Other duties as assigned.

Preferred Education and Experience

• Minimum of 3 years direct Alzheimer’s or Parkinson’s disease clinical trial experience or a minimum of 5 years of research experience in another therapeutic area. Expertise / specialization in Parkinson’s
• disease preferred but not required.
• Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC),
• Association of Clinical Research Professionals – Certified Professional (ACRP-CP), or willing to work to
• meet the criteria in order to apply for certification once hired
• A Bachelor’s degree (Master’s degree preferred)
• Bilingual preferred- Fluent in English and Spanish
• Proven record of successful problem-solving and decision framing skills
• Ability to work independently and remotely
• Capacity to travel up to 50% time each month to 3-4 different geographies, sometimes on short notice
• Strong interpersonal and communication skills

Technical Skills Required

• Microsoft Office including Microsoft Word and Excel
• Proficient PowerPoint skills
• Understanding of and use of social media
• Familiarity and comfort utilizing Sharepoint, Monday.com, Google docs, Google Meet, Zoom and other group sharing and video conferencing sites