Clinical Research Associate II (Eastern Canada)

Premier Research; Deutschland; Hybrid; EUR 40.000 - 56.000; Vollzeit

Zusammenfassung

Premier Research is looking for a Clinical Research Associate II (Eastern Canada) to join our Clinical Monitoring, Site Management and SSU team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. We recognize our team members are the most valuable asset in delivering success.

Qualifikationen

• Undergraduate degree required with minimum 2+ years clinical monitoring experience.
• Strong communication with sites, clients, vendors, and cross-functional teams.
• Willingness to travel up to 70-85% and 8 DOS per month.
• French fluency preferred.
• Must reside in Ontario or Quebec.

Aufgaben

• Perform monitoring activities (on site and remote) including Site Qualification Visits, Initiation Visits, Interim Monitoring Visits, Site Management Contacts, Close Out Visits for Phase I-IV trials and device studies.
• Ensure data validity and integrity in line with protocol, ICH-GCP/ISO standards, and customer requirements.
• Serve as the primary contact for investigative sites, manage queries, support Trial Master File activities, and participate in investigators’ meetings.
• Identify and escalate potential risks and retraining opportunities for sites.
• Schedule and plan day-to-day study activities, ensure timely, high-quality trip reports, and manage deliverables.

Kenntnisse

Clinical monitoring

Site management

Data integrity

Trial management

Ausbildung

Bachelor's degree or international equivalent

Jobbeschreibung

Premier Research is looking for a Clinical Research Associate II (Eastern Canada) to join our Clinical Monitoring, Site Management and SSU team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

• Your ideas influence the way we work, and your voice matters here.

• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

What you’ll be doing:

• Perform monitoring activities (both on site and remote) including Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, Site Management Contacts, Close Out Visits for Phase I-IV clinical trials, as well as device trials with opportunities to work in the following Therapeutic areas: oncology, pediatrics, rare disease.

• Ensure the validity, correctness, and completeness of clinical data collected at sites with a focus on data integrity and patient safety as dictated by trial protocol, ICH-GCP/ISO 141155, and customer requirements.

• Serve as the primary point of contact for investigative sites, manage query resolution, support Trial Master File activities, participate in Investigators’ Meetings, and complete other project tasks in accordance with study timelines and budget.

• Identify and escalation potential risks and possible retraining opportunities for investigative sites.

• Schedule and plan day-to-day activities to include study monitoring visits, timely completion of high quality trip reports, and active management of all deliverables.

What we are searching for:

• Undergraduate degree required or its international equivalent, along with along with minimum of 2+ years previous clinical research monitoring experience required.

• Known for being customer-focused in approach to work and communications with the ability to professionally interact with sites, clients, vendors and other functional areas

• Accountable, dependable and strong commitment

• Ability to meet the requirement of 8 DOS (Days on site)/monitoring visits/month; 70-85% travel, close to major airport

• French fluency preferred

• You must live in Ontario or Quebec