Clinical Research Associate

Location: REMOTE, Alberta

Category: Clinical Development and Operations

Salary: Apply for details

Country: United States

Employment: Direct Hire/Perm

Worksite: On-Site

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Experienced Various Levels – DOE

The Clinical Research Associate (CRA) is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from the source documents. The CRA is the primary contact between the Investigational Sites, and Sponsor.

Key responsibility of a CRA is as a site relationship manager ensuring that clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Client SOPs.

Responsibilities:

- CRAs primary responsibility is to build relationships with Principal Investigators, study co-ordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited, and smooth management of clinical trials.
- Foster internal and external customer relationships to ensure focus on effective, timely and productive project delivery as per study requirements and timelines.
- In collaboration with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA), prepare site essential documents, and support the ethics and regulatory submission and approval processes as needed.
- In collaboration with Regulatory Start-up (RSU) Team, understand the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials.
- Ensure recruitment of participants as per the site target. Drive site recruitment and engagement initiatives and prepare site-specific recruitment plan(s) and update as required.
- Monitoring of investigational sites as per ICH GCP
- 5.18 (Monitoring) and the Clinical Monitoring Plan (CMP) for each study. This includes all monitoring visit types across all phases of a clinical trial including Site Selection, Site Initiation, Site Monitoring and Site Close Out, unblinded pharmacy visits, and co monitoring visits. Visits can be conducted either onsite or remote as per CMP.
- Ensure the rights & wellbeing of trial participants are protected, including consent form checks, patient eligibility confirmation, protocol compliance, investigational drug compliance, and review of Adverse Events/SAEs. Ensure safety issues are reported to the sponsor promptly.
- Verify trial data are accurate and complete, ensure CRF data and queries are completed and resolved as per the study timelines documented in the Clinical Monitoring Plan.
- Ensure all study drug is appropriately stored, dispensed,



accounted for, and reconciled as per the Clinical Monitoring Plan and the Protocol.

Minimum Qualifications & Experience:

- Graduate in a clinical or life sciences-related field. Relevant

Experience/qualifications In Allied Professions May Also Be Considered. Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate. Preferably experience of working in the research, pharmaceutical industry or a related field per job level as follows:

- CRA I: Entry-level training position.
- CRA II: Approximately 1-2 years of Clinical Research Associate experience or

equivalent experience (CRA II fast track) in other roles in the Clinical industry.
- CRA III: At least 2-3 years of Clinical Research Associate experience in the

Clinical industry.
- Senior CRA (SCRA): At least 3-5 years of Clinical Research Associate

experience in the Clinical industry.
- Principal CRA (PCRA): At least 5 years of Clinical Research Associate

experience in the Clinical industry

CRA II

- Responsible for learning the company culture, policies, and procedures through

specialized training called CRA II fast track training program including observational visits for all types of visits (if applicable) and on the job training by supporting the day-to-day CRA activities of clinical project team members such as CRAs and Line managers (LMs).
- Responsible for quality study management and monitoring deliverables at the

country and site level; follows project requirements and applicable country rules, with moderate oversight from the LM or PM.

CRA III

- Provide mentorship to junior staff and can also provide support to the line

manager or project manager as per request.
- Responsible for quality study management and monitoring deliverables at the

country and site level; follows project requirements and applicable country rules, with moderate oversight from the LM or PM.

Senior CRA (SCRA)

- Provide mentorship to junior staff and can also provide support to the line

manager or project manager in the role of Lead Clinical Research Associate.
- Provide the support on ad hoc visits and can be assigned to evaluate and assess junior CRA staff as needed.
- Participate in activities of the Clinical Services department,



including presenting at clinical department meetings, assisting with the development of clinical processes and SOPs. Identify areas of inefficiency in processes and make recommendations for improvements

Principal CRA (PCRA)
- Prepare, review, and deliver CRA training program modules and workshops in collaboration with Clinical Services Training team.
- Act as LCRA on assigned projects according to study-specific, documented

delegation. Possible tasks are outlined in the LCRA Role Description. As a PCRA a high degree of delegation from the PM is expected especially regarding mentoring and matrix management of CRA’s and championing processes with the team.
- Serve as a back-up line manager or formal mentor to assigned CRAs and

IHCRAs; Conduct co-monitoring visits, solo signoffs, and assessment visits as required.
- Assume project management responsibilities, i.e., serve as back-up PM, where

appropriate, under the supervision of a Project Manager or Line Manager.

Equal Opportunity Employer

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate.

We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

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The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

📌 CLINICAL RESEARCH ASSOCIATE (Alberta)
🏢 Planet Pharma
📍 Alberta