Sr Clinical Research Associate

2 days ago

Canada Syneos Health Full time

Job Title: Senior Clinical Research Associate I

Join our team as a Senior Clinical Research Associate I and contribute to the acceleration of customer success in the biopharmaceutical industry.

About the Role

As a Senior Clinical Research Associate I, you will be responsible for performing site qualification, site initiation, interim monitoring, site management and close-out visits to ensure regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.

Key Responsibilities

  • Perform site qualification, site initiation, interim monitoring, site management and close-out visits to ensure regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
  • Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
  • Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
  • Conduct Source Document Review of appropriate site source documents and medical records.
  • Verify required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records.
  • Utilize available hardware and software to support the effective conduct of the clinical study data review and capture.
  • Verify site compliance with electronic data capture requirements.
  • Perform investigational product (IP) inventory, reconciliation and reviews storage and security.
  • Routinely review the Investigator Site File (ISF) for accuracy, timeliness and completeness.
  • Reconcile contents of the ISF with the Trial Master File (TMF).
  • Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
  • Support subject/patient recruitment, retention and awareness strategies.
  • Enter data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
  • Understand project scope, budgets, and timelines for own and others' activities in the clinical team.
  • Manage site-level activities / communication to ensure project objectives, deliverables and timelines are met.
  • Act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate.
  • Prepare for and attend Investigator Meetings and/or sponsor face to face meetings.
  • Participate, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
  • Provide guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
  • May provide training or mentorship to more junior level CRAs.
  • May perform training and sign off visits for junior CRA staff, as assigned.
  • May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager.

About Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

What We Offer

  • A dynamic and collaborative work environment.
  • Opportunities for career development and progression.
  • Supportive and engaged line management.
  • Technical and therapeutic area training.
  • Peer recognition and total rewards program.
  • A company car or car allowance.
  • Health benefits to include Medical, Dental and Vision.
  • Company match 401k.
  • Eligibility to participate in Employee Stock Purchase Plan.
  • Eligibility to earn commissions/bonus based on company and individual performance.
  • Flexible paid time off (PTO) and sick time.

Qualifications

  • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience.
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
  • Must demonstrate good computer skills and be able to embrace new technologies.
  • Excellent communication, presentation and interpersonal skills.
  • Ability to manage required travel of up to 75% on a regular basis.

  • Clinical Research Associate

    4 weeks ago

    Canada Just Fix It, LLC Full time

    Position OverviewAs a Clinical Research Associate at Just Fix It, LLC, you will play a pivotal role in advancing healthcare research initiatives. Your primary focus will be on the evaluation and enhancement of care practices within long-term care facilities.Key Responsibilities1. Collaborate with healthcare professionals to investigate the impact of personal...

  • Research Associate in Clinical Trial Inclusivity

    4 weeks ago

    Canada Rbiq Qbin Full time

    Rbiq Qbin is seeking a highly motivated PhD graduate or post-doctoral researcher to join our team on a pivotal project focused on enhancing inclusivity in clinical trials. POSITION TITLE: Research Associate on Inclusivity, Diversity, Equity, and Accessibility (IDEA) in Clinical Trials POSITION OVERVIEW: This is a full-time opportunity for a recent PhD...

  • Senior Statistical Programmer

    3 days ago

    Canada Everest Clinical Research Full time

    {"title": "Senior Statistical Programmer", "description": "Job SummaryWe are seeking a highly skilled Senior Statistical Programmer to join our team at Everest Clinical Research. As a Senior Statistical Programmer, you will be responsible for leading efforts in resolving day-to-day work-related issues and problems, ensuring quality of deliverables, and...

  • Senior Statistical Programmer

    3 days ago

    Canada Everest Clinical Research Full time

    {"title": "Senior Statistical Programmer", "description": "Job SummaryWe are seeking a highly skilled Senior Statistical Programmer to join our team at Everest Clinical Research. As a Senior Statistical Programmer, you will be responsible for leading efforts in resolving day-to-day work-related issues and problems, ensuring quality of deliverables, and...

  • Clinical Research Associate I

    4 weeks ago

    Canada Accoravillage Full time

    About the PositionWe are seeking a Clinical Research Associate I to become a vital part of our team. If you are eager to engage in research activities, possess strong interpersonal skills, and can execute tasks efficiently while maintaining a keen eye for detail, this role may be the perfect fit for you.Key ResponsibilitiesMeasure vital signs, conduct...

  • Clinical Research Associate

    2 days ago

    Canada Syneos Health Full time

    Job SummaryWe are seeking a highly skilled Clinical Research Associate to join our team at Syneos Health. As a Clinical Research Associate, you will be responsible for managing clinical trials from site initiation to close-out, ensuring compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines.Key ResponsibilitiesConduct site...

  • Clinical Research Associate

    2 days ago

    Canada Syneos Health Full time

    Job SummaryWe are seeking a highly skilled Clinical Research Associate to join our team at Syneos Health. As a Clinical Research Associate, you will be responsible for managing clinical trials from site initiation to close-out, ensuring compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines.Key ResponsibilitiesConduct site...

  • Clinical Research Associate

    2 days ago

    Canada Syneos Health Full time

    Job SummaryWe are seeking a highly skilled Clinical Research Associate to join our team at Syneos Health. As a Clinical Research Associate, you will be responsible for managing clinical trials from site initiation to close-out, ensuring compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines.Key ResponsibilitiesConduct site...

  • Clinical Research Associate

    2 days ago

    Canada Syneos Health Full time

    Job SummaryWe are seeking a highly skilled Clinical Research Associate to join our team at Syneos Health. As a Clinical Research Associate, you will be responsible for ensuring the successful execution of clinical trials by conducting site qualification, site initiation, and site management visits. You will work closely with investigators, site staff, and...

  • Clinical Research Associate

    2 days ago

    Canada Syneos Health Full time

    Job SummaryWe are seeking a highly skilled Clinical Research Associate to join our team at Syneos Health. As a Clinical Research Associate, you will be responsible for ensuring the successful execution of clinical trials by conducting site qualification, site initiation, and site management visits. You will work closely with investigators, site staff, and...

  • Clinical Research Associate

    2 days ago

    Canada Syneos Health Full time

    Job SummaryWe are seeking a highly skilled Clinical Research Associate to join our team at Syneos Health. As a Clinical Research Associate, you will be responsible for ensuring the successful execution of clinical trials by conducting site qualification, site initiation, and site management visits. You will work closely with investigators, site staff, and...

  • Director/Sr. Director of Clinical Operations

    1 month ago

    Canada, CA PharmaIN Full time

    Job DescriptionDirector/Sr. Director, Clinical OperationsOncology ProgramPOSITION TITLE: Director/Sr. Director, Clinical OperationsREPORTS TO: VP, Clinical OperationsPOSITION TYPE: Full-time, exempt position PharmaIN Corporation is a privately held clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, peptide-based...

  • Director/Sr. Director of Clinical Operations

    1 month ago

    Canada, CA PharmaIN Full time

    Job DescriptionDirector/Sr. Director, Clinical OperationsLiver ProgramPOSITION TITLE: Director/Sr. Director, Clinical OperationsREPORTS TO: VP, Clinical OperationsPOSITION TYPE: Full-time, exempt position PharmaIN Corporation is a privately held clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, peptide-based...

  • Clinical Trial Project Leader

    4 weeks ago

    Canada Innovaderm Research Full time

    Role OverviewAs a Clinical Trial Project Leader at Innovaderm, you will play a pivotal role in the success of our clinical research initiatives. Acting as the primary liaison for both internal teams and external stakeholders, you will ensure that all project activities and deliverables are executed efficiently, adhering to timelines and budgetary...

  • Clinical Research Associate I

    1 week ago

    Canada Syneos Health Full time

    About the RoleSyneos Health is seeking a highly skilled and experienced Clinical Research Associate I - Senior to join our team. As a Clinical Research Associate I - Senior, you will be responsible for performing site qualification, site initiation, interim monitoring, site management, and close-out visits to ensure regulatory, ICH-GCP, and protocol...

  • Clinical Research Associate I

    1 week ago

    Canada Syneos Health Full time

    About the RoleSyneos Health is seeking a highly skilled and experienced Clinical Research Associate I - Senior to join our team. As a Clinical Research Associate I - Senior, you will be responsible for performing site qualification, site initiation, interim monitoring, site management, and close-out visits to ensure regulatory, ICH-GCP, and protocol...

  • Clinical Research Associate I

    1 week ago

    Canada Syneos Health Full time

    About the RoleSyneos Health is seeking a highly skilled and experienced Clinical Research Associate I - Senior to join our team. As a Clinical Research Associate I - Senior, you will be responsible for performing site qualification, site initiation, interim monitoring, site management, and close-out visits to ensure regulatory, ICH-GCP, and protocol...

  • Senior Clinical Research Associate I

    5 days ago

    Canada Syneos Health Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Clinical Research Associate I to join our team at Syneos Health. As a key member of our clinical operations team, you will be responsible for ensuring the successful execution of clinical trials, from site qualification to close-out.Key ResponsibilitiesSite Management: Perform site...

  • Senior Clinical Research Associate I

    5 days ago

    Canada Syneos Health Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Clinical Research Associate I to join our team at Syneos Health. As a key member of our clinical operations team, you will be responsible for ensuring the successful execution of clinical trials, from site qualification to close-out.Key ResponsibilitiesSite Management: Perform site...

  • Senior Clinical Research Associate I

    6 days ago

    Canada Syneos Health Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Clinical Research Associate I to join our team at Syneos Health. As a key member of our clinical operations team, you will be responsible for ensuring the successful execution of clinical trials, from site qualification to close-out.Key ResponsibilitiesSite Management: Perform site...