Study Start Up and Regulatory Manager - Canada - Care Access

Description

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

Care Access Study Start Up & Regulatory Manager plays 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 in Canada, along with the US by working with cross-functional groups across the global organization to complete successful pre-site visits and exceed Canadian industry standard timelines to 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. This role will also support the ongoing maintenance of regulatory documents, including working with site teams to maintain the Investigator Site File throughout the study life cycle.

What You'll Be Working On

Duties include but not limited to:

· Working closely with the Canadian Care Access teams, assist in feasibility and site evaluation, including liaising with internal teams to evaluate the feasibility of trial opportunities, and assist in promoting the site for evaluation and award.

· For awarded trials, coordinate all aspects of study start up through to first participant visit, including coordinating source form creation, ethics submissions and approvals, collecting and submitting essential documentation, and the contracting process.

· Lead the process of global study start-up to support site evaluation/selection visits on each new study and help get selected sites successfully activated and ready to consent

· Oversee the execution of Site Activation, regulatory submissions and site activation strategy, adhering to project timelines. Develop, implement, and maintain the Management Plan according to the Scope of Work and Project Plan.

· Provide overall guidance and oversight of programs during initial start-up phase as an integral member of the study start-up team. Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.

· Identify regulatory complexity and challenges and offer creative and practical solutions

· 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

· Support sites through their evaluation and begin start-up activities upon selection

· Review study information and understand start-up timelines, requirements, key contacts, and performance expectations

· Track and report on forecasted and actual SSU submission and approval timelines

· Liaise with key stakeholders across the global organization to communicate needs and establish start-up timelines

· Work closely with the staff onsite to help address their remaining questions about the study

· Support the site through the Site Evaluation Visit, Site Initiation Visit, and greenlight to consent

· Track essential documents and timelines

· Handle submissions to the IRB/REB & management of essential regulatory documents

· Responds clearly & promptly to questions & comments from IRB and/or Sponsor

· Completes application forms accurately & with attention to detail

· Ensure quality is maintained in all investigator site files for assigned studies

· Oversee regulatory activities throughout the duration of the study; supporting clinical operations 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)

· Ensure that any and all information gained during the start-up process is completely transitioned to sites, as required

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.

What You Bring

Knowledge, Skills, and Abilities:

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

· Expert knowledge of Canadian regulatory requirements & submission guidelines (experience in multiple provinces preferred)

· Excellent written and verbal communication skills including good command of the English language.

· 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

· Experience working with Salesforce, Florence and CRIO

· 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+ years of relevant experience completing study start-up activities at a site

· Bachelor's degree in life sciences or equivalent is preferred (5-8 years of experience in lieu of degree)

Benefits- HR TO SUPPORT for country specific benefits

Employees will have access to our Health Benefits and Pension plans, as well as an annual health and wellness allowance.

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.