Clinical Research Associate (Remote Work)

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timePosted 13 days ago location United States salarySalary undisclosed
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Job Description

Our client, a world-leading Pharmaceutical Company is currently looking for a Clinical Research Associate (Remote Work) to join their expanding team.


Position Details:

Job Title: Clinical Research Associate (Remote Work )

Duration: 18 Months Contract

Location: Remote (West Coast candidates preferred)


Note:

Client has the right-to-hire you as a permanent employee at any time during or after the end of contract.

You may participate in the company g roup medical insurance plan


Responsibilities:

Clinical Trial Monitoring

Ensure proper conduct of clinical trials in accordance with the Monitoring Plan and applicable prevailing laws, Good Clinical Practices, and Pharmaceutical standards to achieve project goals, timelines and quality

Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from study start-up through database lock, ensuring relevant timelines and quality deliverables are met

Identify, evaluate and select investigator sites as needed

Serve as the primary point of contact for assigned investigator sites

Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites

Perform site qualification/Pre-Trial Assessment Visits and ensure selected sites have appropriate capabilities and access to patient populations to meet protocol and timeline requirements

Conduct site initiation visits in collaboration with study team members as needed

In collaboration with appropriate study team members, develop and implement effective site recruitment plans that are consistent with the global plan and local requirements

Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators.

Partner with study team to define and support recruitment initiatives at site level

Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure visits and ensure these are conducted accordance to Monitoring Plan, SOPs and commensurate with emerging issues and technologies.

Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution

Perform centralized/risk-based monitoring as required

Significant travel (60-80%) within area is required. May require some international travel and some weekend travel

Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team

Interact with investigator site heath care professionals in a manner which enhances Pharmaceutical's credibility, scientific leadership and in order to facilitate Pharmaceutical's clinical development goals

Collaborate with local regulatory and study team on follow-up and documents revisions needed for optimal regulatory approval

Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators

May Support the study team in following up with investigators regarding the ongoing evaluation of subjects

Identify and address Significant Quality Events or other quality issues at patient and/or site level

In collaboration with appropriate study team members, create and implement corrective actions and preventative actions (CAPA) as needed

Ensure resolution of investigator site issues in order to maintain sound investigator relations

Communicate with investigators, study coordinators and other site staff on a regular basis to build and maintain productive relationships and support investigator engagement through medical and scientific discussion



Job Requirements:

Requirement:

Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations

Minimum 2+ years of demonstrated knowledge of clinical research and development processes and ability to gain command of process details, global and local regulatory requirements, and CRA experience

Must be fluent in English

For individuals based in Canada: Bilingualism (French, English) is an asset

Demonstrated understanding of key operational elements of clinical research (e.g., site selection, monitoring, data acquisition and cleaning, reporting, etc.)

Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s)

Demonstrated ability to participate and support sponsor regulatory interactions/inspections

Demonstrated knowledge of the processes around protocol design and feasibility assessment

Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery