Talent.com
Alimentiv
Remote Clinical Research Associate IIAlimentiv • Charlottetown, Prince Edward Island
Remote Clinical Research Associate II

Remote Clinical Research Associate II

Alimentiv • Charlottetown, Prince Edward Island
30+ days ago
Job type
  • Full-time
  • Remote
Job description
Performs and coordinates all aspects of the clinical site monitoring services, assessing for protocol and regulatory compliance. Responsibilities include driving investigative site and patient recruitment, conducting source data verification, assessing drug accountability, data collection, (regulatory) document collection, performing qualification, initiation, monitoring and close out visits at investigational sites in accordance with corporate, sponsor and regulatory (ICH GCP and other) standards and guidelines. Represents the corporation by maintaining collaborative relationships with stakeholders.

Investigational Site Monitoring (55-60%)

    • Conducts and documents site initiation, routine monitoring and close out visits, reviewing files, forms, and filings to ensure alignment with SOPs, study guidelines and GCP best practices.
    • Work with site staff to verify CRF data are consistent with patient clinical source documents.
    • Monitor, resolve and/or facilitate resolution of queries arising out of regular and/or safety reviews, adverse events, and other data management activities throughout the trial.
    • Conduct remote visits\contacts as requested or as needed.
    • Assess and manage Investigational Product supply including supply, accountability, and destruction\return status.
    • Ensures site staff is trained on all aspects of the study including but not limited to the protocol, study plans and systems.

Site Recruitment and Setup (15-20%)

    • Identify and recruit site investigators, coordinate the movement and delivery of trial materials, samples, tests, and forms, including investigational medicinal product, protocols, SOPs, CRFs, project documents, forms, and support tools.
    • Ensure SOPs in place to optimize patient recruitment providing guidance to site teams of inclusion/exclusion criteria.

Investigational Site Management (10-15%)

    • Primary clinical site contact for any questions or issues that arise from investigational sites.
    • Oversee overall integrity of the study to promote positive working relationships with the site and staff.
    • Facilitate and support site staff with access to study systems and ensure sites are compliant with project specific training requirements.

Project Monitoring Lead (5-10%)

    • May be required to act as lead CRA on small, local, or single modality projects, providing peer training, contributing to the design of monitoring plans, tools, documents, CRFs and protocols as requested.
    • Participate and/or present at study team, kickoff, and investigator meetings, monitor site budget adherence and act as primary contact to sponsors for all monitoring related issues.

Qualifications

    • Undergraduate university degree (Bachelor or Honors Bachelor), & 1-3 years' related experience with initial and On-going training.
      • OR
    • College Diploma/Degree, & 4-6 years related experience +substantial on-going job-related training.

      • Other:
    • Health Sciences, Life Sciences, or Clinical Research Specialty preferred, or RPN Certification/Designation.
$61,000 - $102,000 a year+ bonus

PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.
Create a job alert for this search

Remote Clinical Research Associate II • Charlottetown, Prince Edward Island

Similar jobs

Remote Bilingual Program Manager Position

BioScript SolutionsPE, CA
Remote
Full-time

Step into a vital role as a Remote Bilingual Associate Program Manager at BioScript Solutions, focusing on enhancing patient support programs.Bring your leadership and project management expertise ... Show more

 • Promoted

Remote Market Research Assistant – Earn Up to $50/Task

Occupons QuebecPort Kayla, PE, Canada
Remote
Part-time

Compensation: Up to $50 per task.We are seeking individuals to complete small, remote market research tasks from home.Your insights help shape future products, services, and public trends.All tasks... Show more

 • Promoted

Physical Therapist - Outpatient at Home (Queens)

KinsPE, CA
Full-time

Applicants must be authorized to work for ANY employer in the U.We are unable to sponsor or take over sponsorship of an employment Visa at this time.You became a PT to help people—not to sprint thr... Show more

 • Promoted

Warehouse Associate I

White Cap CanadaCharlottetown, Prince Edward Island, Canada
Full-time

A position at White Cap isn’t your ordinary job.You’ll work in an exciting and diverse environment, meet interesting people, and have a variety of career opportunities.The White Cap family is commi... Show more

 • Promoted • New!

Writer/Journalist Internship Part-Time in Worldwide - Remote Worldwide

The Borgen Projectlot 34, PE, Canada
Remote
Part-time +1

Are you passionate about making a difference in the world? Look no further! The Borgen Project is an international organization that works at the political level to improve living conditions for pe... Show more

 • Promoted

Trauma-Informed Clinical Therapist — Community Impact

TEEMA Solutions GroupCharlottetown, PE, CA
Full-time

A community-based nonprofit organization in Charlottetown, Prince Edward Island is seeking a Clinical Therapist to provide trauma-informed counselling to survivors of sexual violence.The role inclu... Show more

 • Promoted

Earn Money By Taking Surveys - Remote

AlmediaCharlottetown, Canada
Remote
Full-time

Get paid for testing apps, games and surveys.Almedia runs a dynamic platform where users earn money online by completing tasks, playing games, and filling out surveys.Since our launch 5 years ago, ... Show more

 • Promoted

Market Research Associate - No Experience

Clubshop | USCharlottetown, Prince Edward Island
Full-time

Discover The System Surveoo That’s Helping Newbies Earn Daily.Turn your free time into daily earnings by answering simple surveys.No product or tech skills needed.Join For Free And Start Earn... Show more

IT Consultant - Clinical Information System

Government of Prince Edward IslandCharlottetown, PE, CA
Permanent

IT Consultant - Clinical Information System – Government of Prince Edward Island.Join to apply for the IT Consultant - Clinical Information System role at Government of Prince Edward Island.Rochfor... Show more

 • Promoted

Senior Director of Quality in Biologics

BioVectra Inc.Charlottetown, PE, CA
Full-time

Join Agilent Technologies as the Director, Quality Science & Technology, shaping quality strategies for biologics and complex chemistry.Leverage expertise to enhance regulatory compliance and patie... Show more

 • Promoted

Director Of Care (Registered Nurse)

Andrews-Senior-CareCharlottetown, Prince Edward Island, Canada
Full-time +1

Director of Nursing, Andrews Senior Care.Established 80-bed Community Care operation plus primary leadership of the new 90-bed Long Term Care expansion opening January 2027.Are you passionate about... Show more

 • Promoted

Clinician

Resolve Sleep HealthCharlottetown, PE, CA
Full-time +1

Location: Charlottetown PEI | In-Clinic Role.We are looking for a full-time permanent Clinician in Charlottetown, PEI! $1500 Signing Bonus.This is an exciting opportunity for an experienced Clinici... Show more

 • Promoted

Bilingual Associate Program Manager

BioScript SolutionsPE, CA
Full-time +1

Empowering lives, healing hearts, embracing future.Are you ready to make a lasting impact in specialty care? We’re seeking a dedicated and dynamic Bilingual Associate Program Manager to join our Pa... Show more

 • Promoted

RDA II: On-Site Patient Care, X-Rays & Sterilization

Northwest DentistryCharlottetown, PE, CA
Full-time

A dental practice located in Charlottetown, PE is seeking a full-time Registered Dental Assistant to support patient care and assist the dentist during procedures.The ideal candidate will have stro... Show more