Study Start Up Manager
About Care Access
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.
How This Role Makes a Difference
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.
How You'll Make An Impact
- 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
The Expertise Required
- 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)
How We Work Together
- Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.
- Travel: This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.
- Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
The expected salary range for this role is $90,000 - $100,000 USD per year for full time team members.
Benefits & Perks (US Full Time Employees)
- Paid Time Off (PTO) and Company Paid Holidays
- 100% Employer paid medical, dental, and vision insurance plan options
- Health Savings Account and Flexible Spending Accounts
- Bi-weekly HSA employer contribution
- Company paid Short-Term Disability and Long-Term Disability
- 401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we 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 are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, 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.
If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com
Mandatory Employer Disclosures:
Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
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