Senior Clinical Research Associate - Sponsor Dedicated - Ph I Oncology (Home-Based in Alberta)

Syneos Health, Inc.; Canada; Remote; CAD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Senior Clinical Research Associate to join their dynamic team. This role is pivotal in ensuring the highest standards of clinical trial conduct, focusing on site management and compliance with regulatory guidelines. The successful candidate will have the opportunity to work remotely while contributing to impactful projects in oncology. With a commitment to diversity and inclusivity, this forward-thinking organization values every employee's contribution and fosters a supportive work environment. If you are passionate about clinical research and eager to make a difference, this is the perfect opportunity for you.

Qualifications

• Bachelor's degree or RN in a related field or equivalent experience required.
• Knowledge of regulatory requirements and Good Clinical Practice is essential.

Responsibilities

• Perform site qualification, initiation, and monitoring ensuring compliance.
• Document activities and prepare for Investigator Meetings.
• Provide guidance towards audit readiness standards.

Skills

Good Clinical Practice/ICH Guidelines

Communication Skills

Interpersonal Skills

Computer Skills

Project Management

Education

Bachelor’s degree or RN in a related field

Job description

Senior Clinical Research Associate - Sponsor Dedicated - Ph I Oncology (Home-Based in Alberta)

Updated: December 20, 2024
Location: Canada-North America - CAN-Home-Based
Job ID:24006804

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

Job Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
• Assesses site processes as per the Clinical Monitoring/Site Management Plan (CMP/SMP).
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents.
• Understands project scope, budgets, and timelines for own and others’ activities in the clinical team.
• May act as primary liaison with project site personnel.
• Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.
• Provides guidance at the site and project level towards audit readiness standards.
• May provide training or mentorship to more junior level CRAs.
• May be mentored and assigned clinical operations lead tasks under supervision.
• For Real World Late Phase (RWLP), the Sr. CRA I will use the business card title of Sr. Site Management Associate I.

Qualifications

What we’re looking for

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Must demonstrate good computer skills and be able to embrace new technologies.
• Excellent communication, presentation and interpersonal skills.
• Ability to manage required travel of up to 75% on a regular basis.

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway.

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status.