Description

Senior clinical research associates (CRAs) handle the day-to-day operations of the clinical investigative phase of drug development. They are in charge of laboratory and research duties to reach all the organizational objectives. They need to have strong analytical aptitudes and pay strict attention to detail during all clinical research. They also handle experiment inquiries and take assessment notes on a frequent basis. Most senior clinical research associates are in charge of keeping investigative reports and providing project communications.Frequently, senior clinical research associates work in a lab setting, and their schedule can vary according to their projects and company needs.. They are responsible for monitoring experiment tools in this laboratory setting and any variables that may impact the research. They also must effectively train other research associates to operate complex equipment and follow proper laboratory conduct. They also work with different research professionals to share research results and reach different conclusions.A bachelor's degree in a scientific discipline, at minimum, is required for this position, as well as years of successful laboratory experience and additional certifications and/or education. These research associates need to have excellent interpersonal skills to cooperate in a team environment and deliver conclusions to research managers. They are also required to uphold ethical research practices and maintain advanced safety standards.

Roles & Responsibilities

As a Senior Clinical Research Associate CRA with 9+ years of experience in Canada, your main responsibilities include:

  • Conducting site qualification visits, ensuring compliance with protocols, regulations, and Good Clinical Practice GCP guidelines. You will assess potential clinical trial sites for their suitability and adherence to study protocols, regulations, and ethical guidelines.
  • Overseeing site initiation, monitoring, and close-out visits, ensuring data integrity and patient safety. You will provide guidance and support during the entire lifecycle of a clinical trial, ensuring accurate data collection, patient safety, and adherence to study timelines.
  • Training and mentoring junior CRAs, ensuring their knowledge and skills development. You will share your expertise and provide guidance to junior CRAs, supporting their professional growth and ensuring high-quality work.
  • Collaborating with cross-functional teams, including investigators, sponsors, and regulatory authorities.

Qualifications & Work Experience

For a Senior Clinical Research Associate (CRA), the following qualifications are required:

  • The candidate should have a strong background in clinical research and a deep understanding of Good Clinical Practice (GCP) guidelines. They should have worked on multiple clinical trials, demonstrating their knowledge of study protocols, data collection, and management.
  • A Senior CRA should be able to identify and address issues that arise during clinical trials effectively. They should have the ability to analyze complex clinical data, identify trends, and propose appropriate solutions to ensure the integrity of the study.
  • It is crucial for a Senior CRA to have exceptional communication skills to effectively communicate with study investigators, site personnel, and sponsor representatives. They should be able to build strong relationships and effectively collaborate with cross-functional teams.
  • As a Senior CRA, attention to detail is essential to ensure data accuracy and project timelines are met.

Essential Skills For Senior Clinical Research Associate (CRA)

1

Clinical Research

2

Research and Analysis

3

Project Management

4

Research Methods

Skills That Affect Senior Clinical Research Associate (CRA) Salaries

Different skills can affect your salary. Below are the most popular skills and their effect on salary.

Monitoring Data

4%

Career Prospects

The role of a Senior Clinical Research Associate CRA is crucial in the field of clinical research. With 9+ years of experience in Canada, professionals in this role may consider exploring alternative positions. Here are four options to consider:

  • Clinical Trial Manager: A role that involves overseeing the planning, implementation, and management of clinical trials, ensuring adherence to protocols and regulatory requirements.
  • Medical Affairs Specialist: A position focused on providing scientific and medical support to various stakeholders, including healthcare professionals, regulatory agencies, and internal teams.
  • Pharmacovigilance Manager: A role that involves monitoring and evaluating the safety and efficacy of pharmaceutical products, ensuring compliance with global pharmacovigilance regulations.
  • Clinical Operations Manager: A position focused on managing and coordinating the operational aspects of clinical trials, including study site selection, budgeting, and resource allocation.

How to Learn

The role of Senior Clinical Research Associate (CRA) in Canada is expected to experience significant growth in the market. According to a 10-year analysis, the demand for CRAs is projected to rise steadily, reflecting the growing importance of clinical research in the healthcare industry. With advancements in medical technology and an increasing focus on evidence-based medicine, the need for skilled CRAs is likely to continue to rise. This will result in a substantial number of employment opportunities in the future, making it an attractive career choice for individuals interested in the field of clinical research.