Study Start Up Manager

Job description

What We Do

Care Access is a unique, multi-specialty network of research sites that operates as one connected team of physician investigators, nurse coordinators, and operations managers.

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

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

What You’ll Be Working On (Duties include but are not limited to):

• 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

Scope of Role:

• Autonomy of Role: ​Work is performed under general supervision​
• Direct Reports: ​No​

Physical Requirements:

• This role requires 100% of work to be performed in a remote office environment and requires the ability to use keyboards and other computer equipment

Travel Requirements:

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

What You Bring (Knowledge, Skills, and Abilities):

• 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

Certifications/Licenses, Education, and Experience:

• 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)

Benefits:

• PTO/vacation days, sick days, holidays.
• 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.