Clinical Research Associate II (SRI) - Odette Cancer Centre Clinical Trials - Regular Full-time[...]

Sunnybrook Health Sciences Centre; Toronto; On-site; CAD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Clinical Research Associate II to support their oncology clinical trials. This dynamic role involves collaborating with a dedicated team to maintain active studies, ensuring compliance with protocols, and engaging with patients throughout the trial process. The successful candidate will thrive in a fast-paced environment, showcasing their expertise in clinical research while contributing to groundbreaking cancer treatments. If you're passionate about making a difference in clinical research and patient care, this opportunity offers a rewarding career path with comprehensive benefits and a supportive team culture.

Benefits

Health Benefits Plan

Pension Plan

Paid Time Off

Sick Days

Qualifications

• Minimum 3-5 years of clinical research experience required.
• Oncology trial experience preferred, along with SoCRA/CCRP certification.
• Knowledge of ICH guidelines and Good Clinical Practice is essential.

Responsibilities

• Assist with maintenance of oncology clinical research studies and databases.
• Conduct patient assessments, including vital signs and ECG tests.
• Coordinate with internal departments and manage trial-related documents.

Skills

Clinical Research Experience

Oncology Clinical Trial Experience

Organizational Skills

Time Management Skills

Communication Skills

Data Entry Skills

Analytical Skills

Education

Bachelor's Degree in Health or Science

Tools

MS Office (Outlook, Word, Excel, PowerPoint)

Job description

Summary of Duties and Responsibilities:

The Odette Cancer Center (OCC) Clinical Research program is part of Sunnybrook Research Institute’s (SRI) ongoing commitment to participate in innovative and high quality clinical research. Within OCC Clinical Research, the Clinical Trials Manager, Operations Manager, and Budget & Operations Coordinator, work with 35+ physicians actively participating in clinical research and 55+ clinical research staff. Our program is comprised of 12 disease site groups; Breast, CNS, NETS, GI, GU medical, GU radiation, Gynecology, Head & Neck, Hematology, Lung, Melanoma and Personalized Medicine; as well as 2 pan-Canadian initiatives (Personalize My Treatment & The Canadian Cancer Clinical Trials Network (3CTN)).

The goal of this Clinical Research Associate (CRA) II position is to assist the Head & Neck Oncology Disease Site Group with the maintenance of their active oncology clinical research studies, databases, and clinical trials. This position is for a full-time position working weekdays (8hr) on-site at Sunnybrook, Bayview campus. This position is entitled to health benefits plan, pension, and paid time off/sick days.

The goal of this position is to assist with our Head & Neck Disease Site Group with the maintenance of several complex ongoing clinical trials with a split focus on patient-facing responsibilities and protocol activation of new clinical trials. Primary responsibilities include but are not limited to, consenting patients, reviewing trial eligibility criteria; ongoing patient protocol requirements; reporting Adverse Events/Serious Adverse Events; scheduling patient appointments; conducting measurements on patients including vital signs, height/weight measurements, and ECG tests; communication with various hospitals and health service facilities to obtain medical information; data entry and resolving sponsor queries; completing forms and maintaining supportive documentation; and processing blood, urine, or tissue specimens.

In addition, the CRA II will dedicate part of their time to supporting Protocol Activation activities, complete REB submissions, conduct impact assessment and communication with internal hospital departments, coordinate with the budget coordinator, liaising with Contract Research Organizations (CROs) and Sponsors/Trial Lead hospitals to manage the trial master file and applicable documents, SIV coordination, and other activation-related activities.

The CRA II will be based on-site and will report to the Site Lead and PIs, also working closely with an interdisciplinary team including the Clinical Trials Manager, Operations Manager, and all other OCC Clinical Research Program staff. The position will be a regular full-time position entitled to paid vacation & sick time, health benefits package, and HOOPP pension. This position may require walking between depts across Sunnybrook Bayview campus.

The successful candidate will be an eager team player who meets the following qualifications/skills:

Qualifications/Skills:

• Requires the successful minimum completion of a Bachelor’s degree, or recognized equivalent, in a health or science-related discipline with a minimum of 3-5+ years clinical and/or professional experience including at least 3 years clinical research-related experience
• Oncology clinical trial experience and/or Interventional Health Canada Regulated trial experience, highly preferred
• SoCRA/CCRP certification an asset
• Well-developed organizational and time management skills
• Demonstrated knowledge of ICH guidelines, Good Clinical Practice, Division 5, 21CFR11
• Proven experience in processing and shipping blood samples
• Knowledge and experience in the clinical trial protocol activation process
• Familiarity with the Trial Master File and management of trial-related documents
• Experience preparing/submitting research documents to research ethics boards
• Excellent oral and written communication skills
• Ability to follow established trial protocols, guidelines, procedures, and standards
• Demonstrated ability to work collaboratively in a team environment
• Ability to take responsibility in meeting multiple deadlines and making progress on multiple projects with direct and indirect supervision
• Strong analytical skills with close attention to detail
• Experience in data collection, data entry, and query resolution using electronic data capture systems
• Intermediate to advanced skills with MS Office software (Outlook, Word, Excel, PowerPoint)
• Experience with medical terminology and patient-facing communication, including obtaining AE/SAE or other trial-related medical information
• Experience with the informed consent process and experience consenting patients to clinical trials
• Satisfactory attendance

Application screening will continue until a suitable candidate is identified. If your expertise qualifies you for this challenging full-time position, please apply below.

Please submit your resume with your First and Last name in the file name.