Clinical Research Coordinator

ICLS Dermatolgy & Plastic Surgery is looking for a Clinical Research Coordinatorto join their growing team.

This position is a highly dynamic and evolving role involving clinical, administrative, communicative, and organizational skills. The Clinical Research Coordinatorwill work with the site staff under the leadership of the Principal Investigator and Research Manager with a wonderful team of coordinators, nurses and Investigators.

The right candidate will need to have current GCP certification and have a positive attitude. These skills are essential to work in this positive and well-respected clinic.

This is a full-time 12 month contract role for a maternity leave with the opportunity to become permanent based on the right candidate and clinics needs.

Responsibilities:

• Design and implement study tools to monitor and track administrative and clinical activities including but not limited to the following: spreadsheets, databases, source documentation, educational materials and other duties as determined by the Team Lead.
• Conduct patient recruitment, screening, enrollment and retention of eligible subjects.
• Perform informed consent process with subjects.
• Complete study visits with subjects including but not limited to: re-consent, concomitant medication review, source documentation, data entry, biological sample collection and processing, electrocardiogram collection, medical photography, administration of investigational product, investigational product compliance, and vital signs collection.
• Perform data entry and query resolution.
• Travel to Investigator Meetings as required.
• Liaise with physicians, nursing, and laboratory staff, as well as industry representatives.
• Ensures that clinical monitoring activities of their assigned team are performed to the Sponsor’s satisfaction and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices, and study-specific requirements.
• Strong Standard Operating Procedures (SOPs) execution
• Keeps Team Lead and PI apprised and informed of all situations and daily operations.
• Escalates problems swiftly to appropriate parties; Team Lead, PI, Sub-I, and Monitor when applicable.
• Communicate with sponsors and their representatives as well as monitoring agencies or third parties in a respectful manner to schedule and complete tasks.
• Assist in planning and organizing of clinical trial start-ups including feasibility review, submissions when required.
• Strong background in Clinical Research regulatory requirements
• Collaborates and implements methodologies, policies, procedures, and standards in Clinical Research protocol management to ensure quality data including CAPA & ALCOA
• Advises key members on internal Quality Control (QC) findings and ways to continually improve.
• Regularly meets deadlines related to individual as well as team performance on projects/assignments.
• Support audit preparation for any site inspections
• Abide by and advise site on Good Clinical Practice (GCP), standard Operating Procedures (SOPs), company guidelines, and local healthcare and privacy regulations.
• Manage protocol-specific recruitment targets and support efforts to achieve site/company KPIs.
• Interact with investigators, and delegated team members and third-party vendors for successful study execution.

Qualifications:

• A Bachelor of Science, and/or a level of education, training, and experience equivalent to a Bachelor’s degree in a science discipline or related field such as Health Administration, Nursing, Microbiology, or Business Administration.
• Minimum of two years' experience in Clinical Research.
• Experience in a dermatology clinical setting is preferred and knowledge of medical terminology is required.
• A proven professional and tireless work ethic will be an asset in managing multiple projects with hard deadlines.
• A demonstrated ability to act as a member of an interdisciplinary team to plan, organize, implement, trouble shoot and coordinate research projects in a timely and efficient manner.
• An ability to communicate effectively and work independently is critical, as well as the ability to organize and prioritize workload.
• Other qualities that will be considered are attendance record, grooming, and temperament.
• GCP and Health Canada Division 5 certified; IATA certified.
• Phlebotomy Certification is an asset.
• CTMS experience is an asset.

This role will be perfect for you if:

• You are a Clinical Research Coordinator with at least two years' experience on sponsor directed clinical trials.
• You have dermatology research experience.
• You are a Clinical Research professional with a passion for producing the highest quality of research data.
• You thrive working in a dynamic Clinical Research environment.

Job Types: Full-time, Fixed term contract
Contract length: 12 months

Salary: From $25.00 per hour

Schedule:

• Monday to Friday

Application question(s):

• Do you have a Venipuncture/Phlebotomy Certification?
• Do you have experience working in a Dermatology Clinical setting ? If yes, how many?

Experience:

• Clinical Research: 2 years (required)

Licence/Certification:

• GCP and Health Canada Division 5 Certification (required)
• IATA Certification (required)

Ability to Commute:

• Oakville, ON L6J 7W5 (required)

Work Location: In person