Join us as our Clinical Research Associate

Thryv Therapeutics Inc. (previously LQT Therapeutics Inc.) is a privately owned company based in Montreal, Quebec, Canada.  Thryv Therapeutics is pioneering a precision medicine approach to treat genetic and drug-induced Long QT Syndromes, atrial fibrillation, and resistant cancers with potent and selective inhibitors of Serum Glucocorticoid inducible Kinase.

OPPORTUNITY SUMMARY

The Clinical Research Associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and all applicable regulatory requirements.

KEY RESPONSIBILITIES

  • Responsible for all aspects of study site monitoring, including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaising with vendors; and other duties, as assigned.

  • Responsible for all aspects of site management as prescribed in the project plans.

  • General On-Site Monitoring Responsibilities:

    • Ensure that study personnel have received the drug intended for clinical trials.

    • Ensure the protection of study participants by verifying that informed consent procedures and protocol requirements are followed in accordance with applicable regulatory requirements.

    • Ensure the integrity of data submitted to electronic databases following a thorough review of original documents and data.

    • Prepare monitoring reports.

  • Manage projects under the direction of a project manager/director, as required.

  • Monitor a protocol or project and participate in the development of monitoring plans as appropriate.

  • Review progress of projects and take action as necessary to achieve objectives.

  • Organize and give presentations at internal meetings and with investigators.

  • Participate in the development of protocols and case report forms as required.

  • Participate in the writing of clinical trial reports as required.

  • Interact with internal teams to assess needs, resources and time required.

  • Act as contact for clinical trial supplies and other suppliers (vendors) as required.

  • Undertake site assessments.

  • Recruitment of potential investigators, preparation of regulatory submissions, regulatory notifications, translation of study documentation.

  • Carry out the Serious Adverse Event (SAE) reporting process, production of reports, narratives and follow-up of SAEs.

  • Independently carry out CRF review, query generation and resolution based on established data review guidelines or data management processes, in accordance with management instructions.

QUALIFICATIONS

EDUCATION AND WORK EXPERIENCE

  • Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences.

  • Have a minimum of 3 years’ experience in monitoring pharmaceutical industry clinical trials.  Knowledge of several therapeutic areas, including oncology, cardiovascular, early development (Phase 1).

TECHNICAL KNOWLEDGE AND SKILLS

  • Ability to partner closely with investigator and site staff to meet all study timelines.

  • Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).

  • Strong team member and self-starter with the ability to work independently.

  • Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.

NON-TECHNICAL KNOWLEDGE AND SKILLS

  • Exudes the highest level of integrity and an acute sense of ethics.

  • Operates with a sense of urgency and perseverance to achieve results.

  • Ability and enthusiasm to work in a cross-functional team environment.

  • Superior organizational skills and the ability to multi-task and prioritize competing assignments.

  • Excellent oral/written communication, interpersonal, organizational and presentation skills.

  • Proactive and self-motivated with the ability to work independently with minimal supervision.

TRAVEL

  • Based in the Greater Montreal Area.

  • Need to travel up to 50 %.

EQUAL OPPORTUNITY WORKPLACE

Thryv Therapeutics is proud to be an equal opportunity employer. We are committed to equal employment opportunity regardless of race, colour, religion, sex, sexual orientation, gender identity, age, national origin, disability, and any other characteristic protected by law.

APPLY

Please send your resume and cover letter to admin@thryvtrx.com.