Logo of Huzzle

Home

Matches

Explore

Manage

Clinical Research Associate

image

Altasciences

2mo ago

  • Job
    Full-time
    Junior Level
  • Research & Development
    Healthcare
  • Montréal
    Remote
  • Quick Apply

AI generated summary

  • You need a bachelor’s degree, 2 years of clinical experience, knowledge of ICH/GCP, strong communication skills, EDC familiarity, and proficiency in MS Office. Travel may be necessary.
  • You will train on protocols, monitor sites for compliance, document activities, verify data accuracy, review informed consent, manage audits, track adverse events, and train site personnel.

Requirements

  • Bachelor's or equivalent health related (e.g., Medical, Scientific, Nursing) degree preferred.
  • Minimum of 2 years of clinically-related experience, of which a period of 6 months is preferable in clinical research monitoring or equivalent experience.
  • Knowledge of clinical research industry, terminology and practices.
  • Knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
  • Strong verbal and written communication skills.
  • Familiarity with EDC systems; ability to learn required systems quickly and to train others, especially site staff.
  • Ability to meet deadlines, multitask, and prioritize based on study needs. Ability to make sound decisions based on available information.
  • Ability to establish and maintain a good working relationship with site personnel/ colleagues.
  • Ability to work both in a team and independently. Ability to facilitate team meetings and teleconferences. Ability to present at internal study team meeting(s).
  • Proficient with Microsoft Office Word, Excel and Power Point.
  • Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
  • Ability to travel.

Responsibilities

  • Complete Protocol and CMP training for all assigned projects.
  • Identify investigators.
  • Assist in the Creation of Clinical Monitoring Plans (CMP).
  • Performs site qualification, initiation, interim monitoring, site management and close-out visits (on-site or remotely) ensuring regulatory, ICH-GCP and protocol compliance.
  • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and CMP.
  • Assesses site processes.
  • Conducts source documents review of appropriate site source documents and medical records.
  • Verifies required clinical data entered in the case report forms (CRFs) is accurate and complete via review of site source documents and medical records.
  • Applies query resolution techniques (on-site or remotely) and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
  • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject as required/appropriate.
  • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness, and when applicable, compares its content to the Trial Master File (TMF) inventory list.
  • Performs investigational products (IPs) inventory, reconciliation and reviews of storage conditions.
  • Facilitate audits and audit resolution.
  • Process and track (S)AEs.
  • Review study protocols and Informed Consent forms.
  • Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.

FAQs

What is the primary role of a Clinical Research Associate at Altasciences?

The primary role of a Clinical Research Associate at Altasciences is to assist and perform monitoring and site management activities for clinical research projects, ensuring compliance with protocols, regulatory requirements, and standard operating procedures.

What are the education requirements for this position?

A Bachelor's or equivalent health-related degree (e.g., Medical, Scientific, Nursing) is preferred for this position.

How much clinical-related experience is required for this job?

A minimum of 2 years of clinically-related experience is required, with at least 6 months preferably in clinical research monitoring or equivalent experience.

What skills are needed to succeed as a Clinical Research Associate?

Success in this role requires knowledge of clinical research regulations, strong verbal and written communication skills, familiarity with EDC systems, planning and organizational skills, and the ability to establish good working relationships with site personnel.

Will I need to travel for this position?

Yes, the role requires the ability to travel as part of the monitoring and site management activities.

What benefits does Altasciences offer to employees?

Altasciences offers a variety of benefits, including Health/Dental/Vision Insurance Plans, RRSP with Employer Match, Paid Vacation and Holidays, Paid Sick and Bereavement Leave, Employee Assistance & Telehealth Programs, and opportunities for telework when applicable.

Are there any incentive programs available for employees?

Yes, Altasciences provides incentive programs, including training and development programs, an employee referral bonus program, and annual performance reviews.

Does Altasciences prioritize diversity and inclusion in its hiring practices?

Yes, Altasciences is committed to diversity and inclusion and aims to attract, develop, and retain a diverse workforce while ensuring equal consideration for all qualified applicants.

What is the work environment like at Altasciences?

Altasciences fosters a passionate and collaborative work environment where all employees play an important part in the discovery, development, and manufacturing of new drug therapies.

Is training provided for new Clinical Research Associates?

Yes, training is provided, including completing Protocol and Clinical Monitoring Plan (CMP) training for all assigned projects.

image

Altasciences

Quicker go/no-go decisions with integrated preclinical, clinical, bioanalytical, manufacturing, and CRO services.

Science & Healthcare
Industry
1001-5000
Employees
1992
Founded Year

Mission & Purpose

Outsourcing made easy with a one-stop solution to early phase drug development. We are an integrated drug development solution company, offering pharmaceutical and biotechnology companies a proven, flexible approach that removes the need for multiple service providers during the early stages of drug development. Whether for one study or an end-to-end program, we help you reach critical decision-making milestones sooner by improving speed and ease from lead candidate selection to clinical proof of concept, and beyond. When partnering with Altasciences, you can experience up to 40% in time savings thanks to our integrated, one-stop solution offering. We strive to create a true partnership with our clients, our partners, and our colleagues that enables a mutually supporting relationship built on a combination of excellent science and solid communication. Helping sponsors get better drugs to the people who need them, faster, for over 25 years. Our full-service offering is always tailored to your specific research needs: - Preclinical research - Clinical pharmacology - Drug formulation - Manufacturing and analytical services - Bioanalysis - Program management - Medical writing - Biostatics - Data management - And so much more!

Culture & Values

  • Respect

    We are open to differences of opinions and value different viewpoints. We treat each other, our customers, participants in our studies, and the research animals in our care with dignity.

  • Quality and Excellence

    We provide services and solutions of the highest quality, and pride ourselves on challenging the status quo. We strive to exceed expectations by truly giving our best at everything we do.

  • Integrity

    We are honest and uphold strong moral principles. We conduct our business with transparency and high ethical standards.

  • Customer Focus

    We actively partner with our clients. We listen, remain accessible, deliver on commitments, and maintain open channels of communication to build and nurture a lasting relationship based on trust.

  • Employee Development

    We provide leadership, encourage professional development, recognize individual and team contributions, and offer a stimulating, safe working environment.