Licensed Clinical Research Coordinator – Registered Dietitian

What We Do

Care Access is a unique, multi-specialty network of research sites which operates as one connected team of physician investigators, nurse coordinators, and operations managers. Our goal is to engage every healthcare professional in clinical research and to make clinical trials a care option for every patient. 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

We are looking for a Registered Dietitian – Clinical Research Coordinator, who is deeply passionate about promoting awareness, education, and access to clinical research to diverse communities. This role, reporting to the Country Manager and PI’s, is a hybrid position based primarily on site, with remote delivery of personalized Lifestyle Counselling program. The RD-CRC supports both site level trial activities for delegated responsibilities, including eligibility assessment, following participants through protocols, coordinating all aspects of research visits, managing IMP, and assessing nutritional needs, promoting healthy physical activity, and providing personalized Lifestyle Counseling to optimize nutritional status for study participants in sites across Canada.

What You'll Be Working On

Duties include but not limited to:

●      Ability to understand and follow institutional SOPs.

●      Review and assess protocol (including amendments) for clarity, logistical feasibility

●      Ensure that all training and study requirements are met prior to trial conduct.

●      Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.

●      Assist with planning and creation of appropriate recruitment materials.

●      Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.

●      Actively work with recruitment team in calling and recruiting subjects

●      Attend Investigator meetings as required.

●      Perform protocol mandated visits which may include providing personalized Lifestyle Management Counseling, including setting goals for patients based on their background, ethnicity, and/or economical needs and amending as needed per protocol guidelines.

●      Provide helpful materials to assist patients in being successful in achieving their nutritional and physical activity goals

●      Attend remote, video assisted protocol visits, including reviewing applicable study logs, collecting AE, Concomitant Medication changes, and completing eSource 

●      Perform patient diet, nutritional education, including the relationship between good eating habits

●      Schedule study visits with study participants, within protocol window, contact with reminders  

●      Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.

●      Assist in the creation and review of source documents.

●      Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)

Study Management:

●      Prioritize activities with specific regard to protocol timelines

●      Maintain adherence to Health Canada regulations and ICH guidelines in all aspects of conducting clinical trials.

●      Maintain effective relationships with study participants and other care Access Research personnel.

●      Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management.

●      Communicate clearly verbally and in writing.

Patient Coordination:

●      Prescreen study candidates

●      Obtain informed consent per Care Access Research SOP .

●      Complete visit procedures in accordance with protocol.

●      Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.

●      Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.

●      Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)

Documentation:

●      Record data legibly and enter in real time on paper or e-source documents

●      Accurately record study medication inventory, medication dispensation, and patient compliance.

●      Resolve data management queries and correct source data within sponsor provided timelines

●      Assist regulatory personnel with completion and filing of regulatory documents.

Community Engagement:

●      Intellectual Curiosity: Rapidly assimilate new information, integrating it with existing knowledge to address complex topics. Proactively seek answers to 'why' questions to deepen understanding of both subject matter and communities.

●      Exceptional Communication: Deliver clear, engaging presentations to both individuals and groups. Translate complex concepts into easily understandable terms for a general audience.

●      Customer Experience Focus: Show empathy towards partners and participants, and effectively communicate their feedback and suggestions to company leadership.

●      Outreach Initiative: Engage with individuals and groups unfamiliar or uninterested in clinical research, maintaining respect and leaving a positive impression.

●      Impact Orientation: Demonstrate a strong desire to make a meaningful difference in the lives of others through clinical research education and access.

●      Clinical/Healthcare Background: Preference for candidates with a strong foundation in healthcare or clinical research.

Physical and Travel Requirements

Travel Requirements

Candidates must have a willingness to travel within their community and local geographic area. The amount of travel and remote work time will vary by assigned communities.

·   Must have access to reliable, high-speed internet

·  Flexibility to work occasional weekends and/or after normal business hours will be required based on travel, community events, and other business needs

· Must be able to travel via commercial airline

· Must possess and maintain a valid Driver’s License (Valid / Authorized to Drive in Canada)

· Must have and maintain safe driving record in the appropriate province, with a valid license and clean driving record submitted as required

· Must show proof of valid vehicle insurance and registration, if required

Physical Requirements

· Comfortable with occasional extended periods of travel and desk work.

· Ability to manage on-site event coordination and logistics, including physical requirements of setting up and taking down event materials.

What You Bring

The ideal candidate should be self-motivated and passionate about clinical trials and healthcare. Interpersonal skills and the ability to forge and maintain positive working relationships are essential. Experience in medical and/or research fields is strongly preferred but is not mandatory.

Knowledge, Skills, and Abilities:

·  Excellent working knowledge of medical and research terminology

· Excellent working knowledge of federal clinical trial, healthcare, and privacy regulations, and knowledge of good clinical practice (GCP)

· Ability to communicate and work effectively with a diverse team of professionals.

· Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail

·Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel.

·Critical thinker and problem solver

· Friendly, outgoing personality; maintain a positive attitude under pressure.

·High level of self-motivation and energy

·Excellent professional writing and communication skills

·Ability to work independently in a fast-paced environment with minimal supervision.

Certifications/Licenses, Education, and Experience:

· Proof of current provincial Registration as a Registered Dietitian in one or more Canadian provinces required, including meeting the requirements and willingness to register with the Provincial College of RD’s in additional provinces.

·BSc in accredited Dietetics program preferred.

·Ability to perform phlebotomy preferred, willingness for training in phlebotomy required.

· Minimum 2 years of community-based nutrition experience required, clinical nutrition experience preferred.  

· Demonstrates leadership and decision-making capabilities.

·  Bilingual preferred.

· Requires: private office space for working with clinical data with high-speed internet (at minimum: 100MB up and 15MB down, 5 GHz router)

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

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.