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Customer Support / TeleCaller
Clinical Research Associate
Customer Support / TeleCaller
#696748
Remote / WFH
Job Description
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Precision Medicine Group
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.
Precision for Medicine is looking for a CRA II.
Position Summary:
The CRA II provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH) -Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as point of contact for study sites. The CRA is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in complex activities.
Essentials functions of the job included but not limited to:
Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
Updates, tracks and maintains study specific trial management tools/systems, and status reports.
If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses 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.
Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
Travels as necessary according to project needs.
Performs other duties as assigned by management.
Qualifications:
Minimum Required:
Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline.
Minimum of 2 years of on-site monitoring experience; 1 year oncology and Phase I experience preferred
Other required:
High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
Customer service demeanour; demonstrate flexibility and teamwork.
Ability to focus on detail for extended periods of time, high attention to accuracy.
Fluency in English communication, verbally and in writing.
Working knowledge of the drug development process.
Travelling required (60-70%)
Preferred:
Solid experience in clinical research or related experience.
Excellent organizational skills.
Ability to work efficiently in a remote work environment.
Competencies:
Good knowledge and utilization of ICH-GCP, Precision SOPs, and regulatory guidance.
Demonstrates solid interpersonal skills.
Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment.
Good written and verbal communication skills and presentation skills.
Ability to deliver on commitments.
Commitment to performing professionally consistent with Precision Principles.
We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, ****** orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Start of main content
work from home
city, state/territory, postcode or 'remote'
work from home jobs
2,000+ jobs
Relationship Manager
Australian Retirement Trust
Brisbane QLD 4000
Candidate Manager
Talent
Brisbane QLD 4000
Opportunities for promotion
Work from home
View similar jobs with this employer
Business Unit Manager - EndoTherapy
Olympus Australia
Melbourne VIC
Remote work allowance
Employee assistance program
Work from home
Client Associate - Responsible Entity Services – Perpetual Corporate Trust
Perpetual Limited
Sydney NSW
Work from home
Corporate Accounts and Insurance Consultant
Aware Super
Melbourne VIC
Product Manager, Australia
Omnidian
Remote
Annual leave
Opportunities for advancement
Marketing Specialist
Aware Super
Melbourne VIC
Credit Controller
Lander & Rogers
Melbourne VIC
Annual leave
Wellness allowance
Service Hub Consultant
Athena Mortgage
Sydney NSW 2000
Work from home
Senior Finance Partner (International Projects)
Baptist World Aid Australia
North Ryde NSW
Parental leave
Employee assistance program
Extended annual leave
Salary packaging
Work from home
Clinical Research Associate II
Precision Medicine Group
Melbourne VIC
Talent Acquisition Partner
Capricorn Society Limited
Perth WA
Parental leave
Gym membership
Employee rewards program
Wellness program
Associate
Perpetual Limited
Melbourne VIC
Work from home
Broker Support Specialist
Thinktank
Sydney NSW
FACEM – Virtual Emergency Care (Contractor, Remote)
FAST TRACK EMERGENCY
Remote
Work from home
AEW&C Product Support - Support Equipment Analyst
Boeing RIV Site
Brisbane QLD
On-the-job training
Parental leave
Health insurance
Insurance services
Employee assistance program
Salary packaging
View similar jobs with this employer
Technical Officer
Fraser Coast Regional Council
Hervey Bay QLD 4655
Parental leave
Employee discount
Relocation assistance
Employee assistance program
Work from home
Maternity leave
Claims Managers
Australian Retirement Trust
Brisbane QLD 4000
Year 7-10 Maths Assistant Tutor
Contour Education
Glen Waverley VIC
Subscriptions
View similar jobs with this employer
Advisor Creative Services
City of Melbourne
Melbourne VIC 3000
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Financial Analyst
Wotton Kearney
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Employee assistance program
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Aware Super
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Extended annual leave
Salary packaging
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People also searched:
Employers: Post a Job
Precision Medicine Group
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.
Precision for Medicine is looking for a CRA II.
Position Summary:
The CRA II provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH) -Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as point of contact for study sites. The CRA is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in complex activities.
Essentials functions of the job included but not limited to:
Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
Updates, tracks and maintains study specific trial management tools/systems, and status reports.
If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses 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.
Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
Travels as necessary according to project needs.
Performs other duties as assigned by management.
Qualifications:
Minimum Required:
Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline.
Minimum of 2 years of on-site monitoring experience; 1 year oncology and Phase I experience preferred
Other required:
High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
Customer service demeanour; demonstrate flexibility and teamwork.
Ability to focus on detail for extended periods of time, high attention to accuracy.
Fluency in English communication, verbally and in writing.
Working knowledge of the drug development process.
Travelling required (60-70%)
Preferred:
Solid experience in clinical research or related experience.
Excellent organizational skills.
Ability to work efficiently in a remote work environment.
Competencies:
Good knowledge and utilization of ICH-GCP, Precision SOPs, and regulatory guidance.
Demonstrates solid interpersonal skills.
Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment.
Good written and verbal communication skills and presentation skills.
Ability to deliver on commitments.
Commitment to performing professionally consistent with Precision Principles.
We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, ****** orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
