Clinical Research Associate - Toronto, Canada - Optimapharm d.o.o.
1 week ago
Description
Location:
home-based
Who we are?:
Optimapharm is a leading, mid-sized,
full-service CRO working across Europe and North America to deliver new therapies to improve and save patients' lives.
With
27 strategically located offices, Optimapharm operates in 40+ countries, giving unrivaled access to Patients and Investigators in all countries in Europe and North America.
In-depth expertise and long-standing experience, combined with a flexible and collaborative approach, allow optimization of design and planning; through its strong track record of delivery excellence and committed and stable project teams, Optimapharm has secured a high level of repeat business over the years.
We are looking for an
experienced CRA
to join our team in Canada **and support us in making a tangible difference to project sponsors and benefiting patients and their families all around the world.
What do we offer?:
- Working in a successful company that's growing and changing every day
- Working with a highly experienced team of the clinical research professionals
- International projects and professional growth
- Performance bonus
- Training opportunities
Who are we looking for?:
Qualifications and Experience**:
- University degree,
preferably in medical or life sciences; nursing education or other relevant healthcare college degree - At least
23 years
of independent clinical trial monitoring experience: - High level of knowledge of ICH GCP Guidelines, knowledge of regulatory requirements and a strong interest in clinical research
Fluent in English and French; both, written and verbal
- Computer proficiency is mandatory
- Ability to read, analyze, and interpret common scientific and technical journals
- Excellent verbal and written communication skills
- Very good interpersonal and negotiation skills
- Ability to work independently, proactive
- Affinity to work effectively and efficiently in a matrix environment
- A current, valid driver's license
Your responsibilities**:
- Perform routine site visits independently, including prestudy, initiation, interim monitoring and closeout visits
- Manage assigned sites by regular contact with site personnel to ensure site compliance, adequate enrolment and understanding of study requirements
- Independently perform CRF review; query generation and resolution against established data review guidelines or data management systems as applicable
- Identifying and escalating potential risks and identifying retraining opportunities for site personnel
- Preparation of corrective and preventive (CAPA) plans for issues identified during monitoring activities and proactive follow of each, individual CAPA until timely resolution
- Preparation of documents required for EC submissions and notifications, translation of studyrelated documents (where applicable), and other tasks as instructed by the supervisor
- Independently negotiate study budgets with potential investigators/institutions and assist with the execution of site contracts as applicable
- Administration of site payments in accordance with relevant project instructions