Feasibility Manager at Care Access Research | Powderkeg

Location: Remote, US

Employment Type: Full Time - Regular

Team: Global Feasibility

What We Do

Care Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.

Who We Are

We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.

Position Overview

Reporting to the Director of Feasibility, the Feasibility Manager plays a critical role in facilitating the feasibility assessment of protocol and sites for the Care Access Site Network. This role supports the feasibility process by reviewing protocols and determining what sites from the global Care Access Site Network should be proposed for participation. This role will follow the Care Access protocol and site feasibility processes in accordance with industry regulations, Care Access SOPs, and study-specific requirements.

What You'll Be Working On

Duties include but not limited to:

Lead the process of global clinical feasibility planning to support each study proposal and clinical research sites:

● Collect and interpret data from business development team and trial sponsor to understand study requirements

● Review study information and assess feasibility of conducting study at Care Access sites

● Collect and interpret information from Care Access’s site database, site level conversations, and subject matter expert interviews to determine if the study is the right fit for Care Access

● Work with Patient Recruitment to generate patient funnels to understand how many patients are needed at each site to achieve the enrollment expectations established by the sponsor

● Understand site selection criteria from the sponsor

● Manage communication between all relevant parties on a global scale to make the best feasibility decisions, including:

○ Business Development team

○ Principal Investigators and other site staff

○ Regional Site Managers

○ Site Network Leadership

○ Clinical Trial Managers

○ Study Start-Up Team

○ Patient Recruitment team

○ Vendor Management Team

○ Other internal and external experts, as appropriate.

● Prepare required documentation for feasibility assessments and pre-study site visits

● Partner with the Patient Recruitment team and site staff for appropriate intelligence and strategies for recruitment practices and plans

● Ensure that all information gained during the planning and feasibility phase is completely transitioned to sites, as required

● Feasibility Managers may be therapeutically aligned but can expect to support a variety of sites and indications

Physical and Travel Requirements

· This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role

· Operates no tools, machinery, or equipment. No significant lifting

What You Bring

Knowledge, Skills, and Abilities:

● Expert knowledge of general clinical research processes and Good Clinical Practice

● High level of professionalism and confidentiality required

● Excellent interpersonal skills

● Ability to manage against tight timelines and competing priorities

● Excellent written and oral communication skills

● Strong judgment and ability to make evidence-based decisions

● Proficient with Google Suite and Microsoft Office Suite

● Ability to work collaboratively across departments

● Excellent project and process management skills; ability to prioritize in a fast-paced work environment, pivot quickly based on changing business needs, and manage time appropriately

● Ability to build relationships effectively in a geographically dispersed, largely remote environment

Certifications/Licenses, Education, and Experience:

Bachelor’s degree in life sciences or equivalent is preferred

Minimum 3+ clinical research experience with at least 3 years of relevant experience with pre-award feasibility assessment, site identification/site selection, or equivalent experience

Benefits (US Full-Time Employees Only)

● PTO/vacation days, sick days, holiday

● 100% paid medical, dental, and vision Insurance. 75% for dependents

● HSA plan

● Short-term disability, long-term disability, and life Insurance

● Culture of growth and equality

● 401k retirement plan

Diversity & Inclusion

We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success.

At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the best

physicians and caring for patients.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

Care Access is unable to sponsor work visas at this time.

Employment Statement

Care Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.

Job Summary
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