Clinical Research Coordinator

2 weeks ago

Oakville, Canada ICLS Full time

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

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

**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.
- 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.
- CCRC qualified; 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.

**Salary**: From $25.00 per hour

**Benefits**:

- Dental care
- Life insurance
- Paid time off
- Vision care

Schedule:

- Monday to Friday

Application question(s):

- Do you have experience working in a Dermatology Clinical setting ?

**Experience**:

- Clinical Research: 2 years (required)

Licence/Certification:

- CCRC Certification (required)
- GCP and Health Canada Division 5 Certification (required)
- IATA Certification (required)

Work Location: In person

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