Oncology Clinical Research Associate

4 months ago

Laval, Canada Scimega Full time

ROLE

Under the direction of the Director, Clinical and Scientific Affairs, the CTL is responsible for execution of clinical trials, from the site selection, start-up and enrollment phases up to the study closure, in compliance with the industry standards such as Scimega SOPs, ICH-GCP, FDA & Health Canada regulations, and in accordance with our client’s expectations. The CTL is also responsible for customer relationships maintenance, and CRAs supervision.

ACTIVITIES / RESPONSIBILITIES

Site selection and Study start-ups

  • Identify the clients’ expectations/objectives/deliverables
  • Identify the performance metrics
  • Identify the roles and responsibilities all parties involved from the sponsor, the external vendors and Scimega, as well as the communication process within parties.
  • Set up “Kick-off meetings” with our clients
  • Assist with the conduct of feasibility studies
  • Recruit investigators in accordance with the feasibility studies
  • Organize pre-study visits
  • Organize and coordinate start-up activities at the different sites including negotiation of site’s clinical trial agreement and clinical grants
  • Prepare/review training material for the study initiation visits
  • Organize study initiation visits

Study management and maintenance of client relationships

  • Develop and implement internal processes for the conduct of clinical trials, including, but not limited to, the monitoring plan, communication plan, tracking systems, study tools and safety plan
  • Host/Attend conference calls and periodic meetings with clients and prepare  minutes (as applicable)
  • Manage Trial Master File (as applicable)
  • Prepare and distribute progress reports to clients in respect with Scimega’s contractual obligations
  • Prepare and distribute Scimega project review at every 2 months to Director Clinical and Scientific Affairs
  • Interact/Collaborate with different vendors (as applicable)
  • Write newsletters and have them approved by our clients (as applicable)
  • Identify solutions to problems and take the necessary actions to avoid/minimize them and document the action in the Scimega project review
  • Identify clients’ needs and change in the scope of work and communicate the information to the Director Clinical and Scientific Affairs and document in Scimega project review

Supervision of our CRAs 

  • Clearly communicate our client’s expectations, objectives and deliverables (performance measures) to the CRAs
  • Plan and organize CRA training on the specifics of clinical trials and our clients’ needs. Ensure that all CRAs are adequately trained at all phases of the project.
  • Ensure that all trainings are documented with a training log and are in the Scimega training binder.
  • Provide initial study-specific training to new CRAs
  • Schedule regular meetings and conference calls with the CRAs to discuss the progress of each trial and prepare the agenda and minutes.
  • Discuss individually and regularly with each CRA to go over their performance measures
  • Perform QC visit /Accompany CRAs during site visits on a regular basis
  • Review monitoring reports and follow-up letters
  • Support the  CRAs (i.e. provide clarifications and answer questions, as applicable) and help them gain autonomy in their work and be proactive in their daily activities
  • Review and approve CRAs timesheets

 

REQUIREMENTS

Tangibles (qualifications)

  • Education: Bachelor’s Degree in a Health Science field or Registered nurse.  A master degree would be an asset
  • Experience:  Minimum 3 years experience as a CRA or pertinent experience in clinical trial management
  • Other requirements/knowledge:  Excellent knowledge in the field of oncology, very good knowledge of the Good Clinical Practices and regulatory environment
  • Languages spoken and written:  French and English if based in the province of Quebec.  English if based in any other Canadian province.
  • Ability to travel

Intangibles (skills and attitudes)

  • Excellent interpersonal skills
  • Strong organizational skills and ability to handle competing priorities
  • Strong communication (written and verbal) and presentation skills
  • Ability to identify and solve problems
  • Creativity
  • Integrity/Honesty/Ethical behavior
  • Passionate about our field of expertise
  • Accountability
  • Leadership
  • Ability to supervise employees and manage their performance
  • Flexibility
  • Autonomy

  • Clinical Research Associate

    1 week ago

    Laval, Quebec, Canada Scimega Full time

    Job Title: Clinical Research Associate - OncologyScimega is seeking a highly skilled Clinical Research Associate to join our team in the field of oncology. As a Clinical Research Associate, you will be responsible for the execution of clinical trials, from site selection to study closure, in compliance with industry standards and client expectations.Key...

  • Clinical Research Associate

    1 week ago

    Laval, Quebec, Canada Scimega Full time

    Job Title: Clinical Research Associate - OncologyScimega is seeking a highly skilled Clinical Research Associate to join our team in the field of oncology. As a Clinical Research Associate, you will be responsible for the execution of clinical trials, from site selection to study closure, in compliance with industry standards and client expectations.Key...

  • Clinical Research Associate

    2 weeks ago

    Laval, Quebec, Canada Scimega Full time

    {"title": "Clinical Research Associate - Oncology", "content": "Job SummaryScimega is seeking a highly skilled Clinical Research Associate - Oncology to join our team. As a key member of our clinical trials team, you will be responsible for the execution of clinical trials in the oncology field, ensuring compliance with industry standards and client...

  • Clinical Research Associate

    2 weeks ago

    Laval, Quebec, Canada Scimega Full time

    {"title": "Clinical Research Associate - Oncology", "content": "Job SummaryScimega is seeking a highly skilled Clinical Research Associate - Oncology to join our team. As a key member of our clinical trials team, you will be responsible for the execution of clinical trials in the oncology field, ensuring compliance with industry standards and client...

  • Clinical Research Associate

    3 weeks ago

    Laval, Quebec, Canada Scimega Full time

    Job SummaryWe are seeking a highly skilled Clinical Research Associate to join our team at Scimega. As a Clinical Research Associate, you will be responsible for the execution of clinical trials, from site selection to study closure, in compliance with industry standards and client expectations.Key ResponsibilitiesSite Selection and Study Start-upsIdentify...

  • Clinical Research Associate

    3 weeks ago

    Laval, Quebec, Canada Scimega Full time

    Job SummaryWe are seeking a highly skilled Clinical Research Associate to join our team at Scimega. As a Clinical Research Associate, you will be responsible for the execution of clinical trials, from site selection to study closure, in compliance with industry standards and client expectations.Key ResponsibilitiesSite Selection and Study Start-upsIdentify...

  • Clinical Research Associate

    3 weeks ago

    Laval, Quebec, Canada Scimega Full time

    Job SummaryWe are seeking a highly skilled Clinical Research Associate to join our team at Scimega. As a Clinical Research Associate, you will be responsible for the execution of clinical trials, from site selection to study closure, in compliance with industry standards and client expectations.Key ResponsibilitiesSite Selection and Study Start-upsIdentify...

  • Clinical Research Associate

    3 weeks ago

    Laval, Quebec, Canada Scimega Full time

    Job SummaryWe are seeking a highly skilled Clinical Research Associate to join our team at Scimega. As a Clinical Research Associate, you will be responsible for the execution of clinical trials, from site selection to study closure, in compliance with industry standards and client expectations.Key ResponsibilitiesSite Selection and Study Start-upsIdentify...

  • Research Associate

    3 weeks ago

    Laval, Quebec, Canada Scimega Full time

    Job SummaryWe are seeking a highly skilled Clinical Research Associate to join our team at Scimega. As a Clinical Research Associate, you will be responsible for the execution of clinical trials, from site selection to study closure, in compliance with industry standards and client expectations.Key ResponsibilitiesSite Selection and Study Start-upsIdentify...

  • Research Associate

    3 weeks ago

    Laval, Quebec, Canada Scimega Full time

    Job SummaryWe are seeking a highly skilled Clinical Research Associate to join our team at Scimega. As a Clinical Research Associate, you will be responsible for the execution of clinical trials, from site selection to study closure, in compliance with industry standards and client expectations.Key ResponsibilitiesSite Selection and Study Start-upsIdentify...

  • Clinical Research Project Manager

    1 month ago

    Laval, Quebec, Canada Scimega Full time

    POSITION SUMMARYUnder the guidance of the Director of Clinical and Scientific Affairs, the Clinical Trial Leader (CTL) is accountable for the management of clinical studies, overseeing the entire process from site selection and initiation to enrollment and study closure. This role ensures adherence to industry standards, including Scimega SOPs, ICH-GCP, FDA,...

  • Research Associate or Research Associate

    3 weeks ago

    Laval, Quebec, Canada Institut national de la recherche scientifique Full time

    Job SummaryWe are seeking a highly skilled Research Associate or Research Associate to join our team at the Institut national de la recherche scientifique. The successful candidate will be responsible for conducting research in the field of chemistry, specifically in the area of organometallic synthesis and bioinorganic chemistry.Key ResponsibilitiesDesign...

  • Research Associate or Research Associate

    3 weeks ago

    Laval, Quebec, Canada Institut national de la recherche scientifique Full time

    Job SummaryWe are seeking a highly skilled Research Associate or Research Associate to join our team at the Institut national de la recherche scientifique. The successful candidate will be responsible for conducting research in the field of chemistry, specifically in the area of organometallic synthesis and bioinorganic chemistry.Key ResponsibilitiesDesign...

  • Research Associate or Research Associate

    3 weeks ago

    Laval, Quebec, Canada Institut national de la recherche scientifique Full time

    Job SummaryWe are seeking a highly motivated and experienced Research Associate or Research Associate to join our team at the Institut national de la recherche scientifique (INRS). The successful candidate will be responsible for conducting research in the field of bioinorganic chemistry, collaborating with our existing research team, and contributing to the...

  • Research Associate or Research Associate

    3 weeks ago

    Laval, Quebec, Canada Institut national de la recherche scientifique Full time

    Job SummaryWe are seeking a highly motivated and experienced Research Associate or Research Associate to join our team at the Institut national de la recherche scientifique (INRS). The successful candidate will be responsible for conducting research in the field of bioinorganic chemistry, collaborating with our existing research team, and contributing to the...

  • Clinical Trials Project Manager

    1 month ago

    Laval, Quebec, Canada Scimega Full time

    POSITION SUMMARYUnder the guidance of the Director of Clinical and Scientific Affairs, the Clinical Trial Leader (CTL) is tasked with overseeing the execution of clinical trials. This includes managing the site selection, initiation, enrollment phases, and study closure, ensuring adherence to industry standards such as Scimega SOPs, ICH-GCP, and FDA & Health...

  • Bilingual Clinical Specialist

    4 days ago

    Laval, Canada BAXTER Full time

    **This is where you save and sustain lives** At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...

  • Research Associate I

    4 months ago

    Laval, Canada Charles River Laboratories Full time

    **Req ID #**:222464**Location**:Laval, Quebec, CA, H7V 4B3- For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life...

  • Research Associate Immunology

    4 months ago

    Laval, Canada Charles River Laboratories Full time

    **Req ID #**:220008**Location**:Laval, Quebec, CA, H7V 4B3- For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life...

  • Research Associate in Organometallic Chemistry

    1 month ago

    Laval, Quebec, Canada Institut national de la recherche scientifique Full time

    About the RoleAs a Research Associate in Organometallic Chemistry at INRS, you will contribute to cutting-edge research under the guidance of a leading professor in the field. Your primary focus will be collaborating with a dedicated team to design innovative catalysts and therapeutic agents.Key Responsibilities:Actively participate in the development and...