Clinical Research Manager
6 months ago
**ICLS Dermatology & Plastic Surgery** is looking for a Clinical Research Manager or Senior 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 Leader will work with the site staff under the leadership of the Principal Investigator and senior leaders with a wonderful team of coordinators, nurses and Investigators.
We are looking for a strong clinical research professional who excels in clinical research, organization, and execution; develops schedules, tasks and assignments that align with the planned strategies and produce optimal results.
**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.
- 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 Masters degree, 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 five years' experience in clinical research.
- Minimum of two years of successfully leading
**Job Types**: Full-time, Permanent
**Salary**: $28.00-$35.00 per hour
**Benefits**:
- Dental care
- Flexible schedule
- Life insurance
- Paid time off
- Store discount
Schedule:
- 8 hour shift
- Monday to Friday
Supplemental pay types:
- Bonus pay
Application question(s):
- What is your highest level of education and what did you study?
**Experience**:
- Clinical Research: 5 years (required)
- Leadership: 2 years (required)
Ability to Commute:
- Oakville, ON L6J 7W5 (required)
Ability to Relocate:
- Oakville, ON L6J 7W5: Relocate before starting work (required)
Work Location: In person
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