Clinical Research Associate/Clinical Study Monitor

Clinical Research Associate/Clinical Study Monitor

June 15, 2022 By

Introduction:

We are looking for an experienced and assertive senior-level Clinical Research Associate/Clinical Study Monitor who would be responsible for the overall monitoring of clinical trials, ensure compliance with the clinical trial protocol, and create monitoring plans for clinical trials. The ideal candidate must be assertive and willing to challenge team members (including those in a position of authority) and question decisions in time-sensitive and stressful situations. Additionally, the Clinical Research Associate/Clinical Study Monitor must make certain that the scientific integrity and quality of the data collected are protected and verified and assure that adverse events are correctly documented and reported.

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Why join us

Best workplace
We nourish an environment devoted to honesty and fairness, trust and respect. We care deeply for our team members and take work-life balance seriously, allowing our people to decide on a schedule that best fits their life and working preferences.

Best people
We unite cross-industry professionals with a shared passion for improving people’s health and wellness. Our inspiring leaders are accessible and work eagerly side-by-side with individual employees to help them understand and achieve their objectives.

Best opportunities
We encourage our team members to continuously develop and enhance their skills and expertise. We recognize and reward courageous choices and innovative ideas that result in the growth of our people and company, and in the success of our clients.

Become a part of a purpose-driven and future-oriented business that impacts and improves millions of lives worldwide!

Responsibilities:

  • Develops and implements monitoring plans and reporting procedures, methods, guidelines, and tools; participates in the establishment of baseline parameters and edit check specifications, and in the development and implementation of subject tracking systems as well as Site and Trial Master Files.

  • Oversees the development, execution, monitoring and closeout of clinical trial protocols from a compliance perspective; ensuring research site and personnel compliance with all relevant guidelines including but not limited to ICH-GCP E6(R2).

  • Participates in the assessment of external clinical sites as necessary, both nationally and internationally (if any); conducts pre-study site visits, collects and reviews data, and prepares evaluative/monitoring reports that detail this assessment.

  • Conducts clinical trial site initiation visits (SIV’s); advises and trains site personnel on sponsor and regulatory requirements for study conduct; participates and/or conducts site meetings and multicenter investigator meetings and prepares reports.

  • Conducts site monitoring visits and follow-ups to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with all applicable regulations, guidelines, local laws and policies.

  • Reviews on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides remedial training and/or initiates corrective action as required.

  • Ensures appropriate transmission of clinical case data; reviews case report queries and problems, and clarifies and/or obtains changes to data as appropriate.

  • Assists in the termination of clinical studies by identifying items and issues for review and/or follow-up; assemble necessary documents, conducts site termination visits to include test article reconciliation and disposition, review of completeness and accuracy of files, and retrieval of relevant codes and documents; prepares study termination reports.

Qualifications 

  • Bachelor’s degree in Sciences, Health Sciences or Nursing.

  • Preferred: SOCRA CCRP or ACRP certification OR equivalent CRO industry experience.

  • Minimum 5 years of clinical trial experience with solid experience in creating and adhering to monitoring plans.

  • Must be experienced in designing Monitoring Plans. 
  • Exceptional interpersonal communication skills and professionalism.

  • Ability to work individually and as part of a team in a dynamic, efficient clinic setting.

  • Accountable and accurate, with a strong sense of attention to detail.

  • Comfortable handling important and private information while multi-tasking and working in a fast-paced environment.

In addition to the skills and qualifications above, we value the following qualities in all of our team members:

  • Ability to work independently with little supervision or as a team.

  • Willingness to take on challenges and learn in an ever-changing regulatory landscape.

  • Proficiency in using MS Office applications.

  • Strong attention to detail.

  • Strong problem-solving skills.

  • Strong verbal and written skills.

  • Ability to manage and prioritize tasks in a fast pace, hard-deadline environment.

  • Willingness to travel to client sites as needed.

Job Type: Full-time.  

Location: Toronto, ON office.

Applying:

To be considered for future opportunities, please email your cover letter, resume/CV, and any related supporting documentation to hr@dicentra.com with “Clinical Research Associate/Clinical Study Monitor” in the subject line.

As part of the hiring process, in addition to interviewing, successful candidates may be required to complete a skills assessment and a reference/background check. If you are sent a skills assessment, please complete it for consideration for the advertised position.

We thank all applicants for their interest, however, only those selected for an interview will be contacted.