Clinical Research Coordinator

Care Access; Northwestern Ontario; On-site; CAD 50,000 - 80,000; Full time

Job summary

An established industry player is seeking a dedicated Clinical Research Coordinator to join their innovative team. In this pivotal role, you will utilize your expertise in Good Clinical Practices to screen and enroll study participants, ensuring compliance with protocols and regulations. Your strong organizational and communication skills will be essential as you coordinate with investigators and manage patient interactions. With a commitment to advancing medical breakthroughs, this opportunity offers a chance to make a significant impact on clinical research and patient care. Join a mission-driven organization that values diversity and fosters an inclusive culture, where your contributions will be recognized and appreciated.

Benefits

6 weeks paid vacation annually

Access to group health benefits plan

Voluntary group RRSP retirement plan with matched contributions

Qualifications

• Minimum 1 year prior Clinical Research Coordinator experience required.
• Excellent working knowledge of medical and research terminology.

Responsibilities

• Screen, enroll, and monitor clinical research study subjects.
• Ensure protocol and regulatory compliance throughout the study.
• Coordinate recruitment efforts and maintain effective relationships.

Skills

Medical terminology

Good Clinical Practices (GCP)

Organizational skills

Leadership skills

Communication skills

Problem-solving

Attention to detail

Self-motivation

Education

Bachelor’s Degree

Equivalent combination of education, training and experience

Tools

Clinical trials database

IVR systems

Electronic data capture

MS Word

MS Excel

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

The Clinical Research Coordinator’s primary responsibilities are to utilize Good Clinical Practices (GCPs) in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.

What You'll Be Working On

Duties include but are not limited to:

1. Ability to understand and follow institutional SOPs.
2. Review and assess protocol (including amendments) for clarity, logistical feasibility.
3. Ensure that all training and study requirements are met prior to trial conduct.
4. Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.
5. Assist with planning and creation of appropriate recruitment materials.
6. Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.
7. Actively work with recruitment team in calling and recruiting subjects.
8. Attend Investigator meetings as required.
9. Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
10. Assist in the creation and review of source documents.
11. Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords).

Study Management:

1. Prioritize activities with specific regard to protocol timelines.
2. Maintain adherence to Health Canada Division 5 regulations and ICH guidelines in all aspects of conducting clinical trials.
3. Maintain effective relationships with study participants and other Care Access personnel.
4. Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access personnel and management.
5. Communicate clearly verbally and in writing.

Patient Coordination:

1. Prescreen study candidates.
2. Obtain informed consent per Care Access SOP.
3. Complete visit procedures in accordance with protocol.
4. Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
5. Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.
6. Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate).

Documentation:

1. Record data legibly and enter in real time on paper or e-source documents.
2. Accurately record study medication inventory, medication dispensation, and patient compliance.
3. Resolve data management queries and correct source data within sponsor provided timelines.
4. Assist regulatory personnel with completion and filing of regulatory documents.
5. Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Physical and Travel Requirements:

• This is an on-site position with regional commute requirements. Regularly planned travel within the region will be required as part of the role. Overnight travel will be minimal (<10%).

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

• Excellent working knowledge of medical and research terminology.
• Excellent working knowledge of federal regulations, good clinical practices (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:

• Bachelor’s Degree preferred, or equivalent combination of education, training and experience.
• A minimum of 1 year prior Clinical Research Coordinator experience required.
• Recent phlebotomy experience required.

Benefits:

• 6 weeks paid vacation annually.
• Access to group health benefits plan for self and dependents.
• Voluntary group RRSP retirement plan with matched contributions.

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.