Clinical Affairs Associate - Vancouver, Canada - Response Biomedical

Response Biomedical

Verified Company

Vancouver, Canada

3 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Who we are:
Response Biomedical Corp.

has been transforming acute care diagnostic testing, with the central focus on improving patient outcomes and healthcare reform for over 20 years.

Response Biomedical fosters a values-based culture, committed to making diversity and inclusion our way of doing business.

We believe the people we work with including our partners, medical teams, and employees are the cornerstone of our success.

What we do:

Our RAMP platform is a global leader in diagnostic testing solutions for use in cardiovascular, infectious disease, sepsis, women's health, arbovirus, and biodefense.

We understand the stresses associated with rapid, accurate diagnosis when every minute counts, and are committed to collaborating with the teams that are dedicated to saving lives.

We do this by providing lab-quality results within minutes that medical teams can trust, while reducing total cost of care.

Who we are looking for?

We are seeking for a seasoned Clinical Affairs Associate who is dynamic, self-motivated and enjoys working in a fast paced environment.

The Clinical Affairs Associate is responsible for the development of Clinical Affairs infrastructure and program operations to ensure high quality and timeliness of clinical trials.

Oversees operational aspects of all clinical studies and provides strategic direction for clinical trial operations through the direct line-management of the clinical research staff or Contract Research Organizations (CROs).

The Clinical Affairs Associate is responsible for the development and implementation of clinical research and relevant regulatory processes and systems, for the core purpose of improving patient outcomes and saving lives globally.

Key Responsibilities:

Develop clinical strategies and protocols for new products ensuring scientific and clinical integrity.
Assume overall responsibility for the preparation of protocols and Case Report Forms, finalization of monitoring and data management options (either inhouse or contracted to a Contract Research Organization), Ethics committee approval, development of recruitment strategies to increase patient randomization into the trial, the provision of clinical trial materials, and management of the trial.
Ensure that all aspects of GCP are complied with at all times through provision of training at startup and initiation meetings for clinical trials and ongoing SOP development.
Coordinate the smooth monitoring of all trials by identifying and managing qualified staff, establishing audit procedures and ensuring that cleaned data is entered into the database in a timely fashion ensuring accuracy and completion of essential documents.
Ensure the smooth running of clinical research activities by developing systems to track projects including all study, investigator and ethical review board information, patient recruitment activity and financial management.
Contribute to the financial management of the clinical trial programme including budget planning, resource allocation and preparation of reports.
Participates in Project Teams, ensuring that colleagues are updated on all relevant clinical issues. Provide customer input to Project Teams to enable them to develop programs/products along with the applicable regulatory requirements.
Collaborate with Quality Assurance and Regulatory to investigate, develop and recommend clinical and regulatory strategies that are compliant and plays a key role in the preparation for the regulatory submission processes globally.

Education, Work Experience, Knowledge, and Skills:

Formal Education_
A degree in science or a related field, or equivalent experience in a clinical research setting
Work Experience_
Strong understanding of ICH-GCP and clinical research process
Skills & Knowledge_
Well organized and fastidious with uptodate information regarding the clinical research industry
Superb observational and record keeping skills
Outstanding communication (written and oral), organization, presentation, selling, negotiation and analytical skills.
We regret that relocation will not be provided._
We're committed to a diverse and inclusive workplace. We welcome applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. All employment decisions are based on business needs, job requirements and individual qualifications._