In-House Clinical Research Associate

WEP Clinical; Canada; Hybrid; CAD 60,000 - 80,000; Full time

Job summary

WEP Clinical is seeking an In-House Clinical Research Associate to support clinical trials and ensure compliance with regulatory requirements. This role involves coordinating site monitoring, managing documentation, and working within a multi-disciplinary team to advance medical research. Candidates should have a relevant degree and experience in clinical research, with strong organizational and communication skills.

Benefits

Medical, dental, and vision insurance

401K safe harbor plan and company match

Paid vacation, holiday, and sick time

Paid maternity & paternity leave

Qualifications

• 2+ years’ experience in project management, clinical trials, and/or clinical research.
• Bachelor’s degree preferred in a relevant field.
• Strong organizational skills and attention to detail.

Responsibilities

• Coordinate aspects of clinical monitoring and site management.
• Support the project team in feasibility and site processes.
• Ensure accurate documentation and reporting of safety events.

Skills

Detail Oriented

Problem Solver

Team Player

Adaptable

Education

Bachelor’s degree in a science, nursing, pharmaceutical or related field

Tools

Microsoft Office

Job description

Are you passionate about supporting the successful execution of clinical trials and ensuring the development of life-changing therapies? At WEP Clinical, we are dedicated to helping patients gain early access to innovative treatments. We offer a collaborative environment where your contributions are valued, and we provide opportunities for both professional growth and personal fulfillment. Join our team as an In-House Clinical Research Associate and play a key role in advancing medical research while making a real impact on patients' lives!

Role Objectives:

The WEP Clinical In-House Clinical Research Associate (In-House CRA) coordinates aspects of clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA/MHRA/EMA guidelines, local regulations and WEP Clinical Standard Operating Procedures.

The In-House CRA provides operational support to ensure the effective and efficient delivery of clinical site monitoring and regulatory requirements as well as manages required documentation.

The In-House CRA will be a part of a multi-disciplinary team that provides scientific, statistical, operational, and support for clinical trials and Expanded Access Programs (EAP).

The Ideal Candidate:

• Team Player
• Detail Oriented
• Problem Solver
• Adaptable

What You'll Do:

• Support the project team in the feasibility and site process, including collecting relevant data and tracking site feasibility progress.
• Schedule and ensure on-site or remote monitoring visits (Investigator Meetings (IM), Qualification Visits (QV), Site Initiation Visit (SIV), Interim Monitoring Visit (IMV), and Close Out Visit (COV)) occur in accordance with project timelines and requirements.
• Facilitating or scheduling site trainings required per study protocol.
• Support the development of required documentation such as protocols, informed consent forms, case report forms.
• Support the development of required monitoring related documentation such as Monitoring Plans, Visit Reports, Confirmation Letters, Follow-Up Letters, and Action Item Logs.
• Coordinate with sites to resolve queries, actions items, data discrepancies and protocol deviations.
• Ensure accurate documentation and reporting of safety events according to protocol and regulatory requirements.
• Ensure timely, consistent and maintenance of Trial Master File for monitoring related documents.
• Ensure timely, consistent and maintenance of Clinical Trial Management System for monitoring related activities.
• Address protocol or monitoring related questions received from sites for assigned programs.
• Proactively identifies and communicates site performance and monitoring issues to key stakeholders and implements action plans in conjunction with the project team.
• Perform miscellaneous job-related duties as assigned.

What You'll Need:

• 2+ years’ experience in project management, clinical trials, and/or clinical research, (or equivalent combination of education, experience, and expertise)
• Bachelor’s degree (in a science, nursing, pharmaceutical or related field preferred)
• Computer literacy and proficient in Microsoft Office
• Strong organizational skills and attention to detail
• Positive attitude and ability to interact with all levels of staff to coordinate and execute project activities
• Ability to manage multiple priorities
• Effective verbal and written communication skills

What We Offer:

Medical, dental, and vision insurance, FSA, HSA

Voluntary short-term and long-term disability insurance

Voluntary life insurance

401K safe harbor plan and company match

Paid vacation, holiday, and sick time

Paid maternity & paternity leave

What sets us apart:

WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.

We're Committed to Our Team:

WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, and all that we do to support our employees.

We're Committed to DEI:

At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.

Our services include:

Access Programs

Clinical Trial Services

Patient Site Solutions

Clinical Trial Supply

Market Access and Commercialization

WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.

WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.

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