Study Start Up Manager

Care Access

13h•$90,000 - $100,000•Remote

About The Position

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit www.CareAccess.com. Care Access Study Start Up Managers play a critical role in facilitating the start-up activities needed to select and activate studies at sites within Care Access. This role supports the selection and start-up process for our sites by leading cross-functional groups across the global organization to complete successful pre-site visits and accelerate site activation. This role will follow the Care Access study start-up processes in accordance with industry regulations, Care Access SOPs, and study-specific requirements.

Requirements

Expert knowledge of general clinical research processes and Good Clinical Practice
Excellent written and verbal communication skills
High level of professionalism and confidentiality required
Excellent interpersonal skills
Ability to manage against tight timelines and competing priorities
Strong judgment and ability to make evidence based decisions
Proficient with 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
Ability to independently coordinate and manage new processes
Ability to establish and maintain effective working relationships with coworkers, managers and clients
Minimum 3+ years clinical research experience with at least 1 year of relevant experience completing study start-up activities at a site
Bachelor’s degree in life sciences or equivalent is preferred (6-10 years of experience in lieu of degree)

Responsibilities

Collect and interpret information from the Protocol, business development sold strategy & site feasibility team to prepare the site staff for site evaluation visits
Oversee the execution of Site Activation, site activation strategy, adhering to project timelines. Develop, implement, and maintain the Management Plan according to the Scope of Work and Project Plan.
Lead the process of study start-up to support site evaluation/selection visits on each new study and help get selected sites successfully activated and ready to consent
Support the site through the Site Evaluation Visit, Site Initiation Visit, and greenlight to consent
Collect and interpret information from the Protocol & Site Feasibility team to help prepare the sites and site staff that have been chosen for site evaluation visits
Collect and review study activation requirements, understand startup timelines, key contacts & performance expectations
Manage communications and expectations with client (Sponsor and/or CRO)
Provide overall guidance and oversight of programs during initial start-up phase as an integral member of the study start-up team.
Manage communications and expectations with site staff
Support sites through their evaluation and begin start-up activities upon selection
Work closely with the staff onsite to help address their remaining questions about the study
Ensure that any and all information gained during the start-up process is completely transitioned to sites and other central teams, as required
Partner with other Care Access teams to initiate other Study related processes at the appropriate SSU milestone (e.g. capacity planning, systems build requests, etc)
Liaise with internal key stakeholders across the organization to establish timelines and needs
Liaise with key stakeholders across the global organization to communicate needs and establish start-up timelines
Both drive & support Care Access sites throughout the activation process, ensuring risk assessment, mitigation support and start up success
Assist with triggering internal departments- such as (but not limited to) source, vendor management, operational compliance, etc.
Manage vendor requirements
Start up escalation & mitigation
Track and report on forecasted and actual SSU submission and approval timelines