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FSP CRA (Level II)

  • Job
    Full-time
    Junior Level
  • Research & Development
    Healthcare
  • Melbourne
    Remote

AI generated summary

  • You need a relevant degree or nursing certification, 1+ year of monitoring experience, strong communication and organizational skills, ability to travel 80%, and a valid driver's license.
  • You will monitor clinical sites, ensure protocol compliance, document findings, manage investigator relationships, and facilitate communication while addressing issues and maintaining audit readiness.

Requirements

  • Bachelor's degree in life related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor).
  • Valid driver's license.
  • Proven clinical monitoring skills
  • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
  • Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
  • Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
  • Ability to manage Risk Based Monitoring concepts and processes
  • Good oral and written communication skills, with the ability to communicate effectively with medical personnel
  • Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues
  • Good organizational and time management skills
  • Effective interpersonal skills
  • Attention to detail
  • Ability to remain flexible and adaptable in a wide range of scenarios
  • Ability to work in a team or independently as required
  • Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
  • Good English language and grammar skills
  • Good presentation skills
  • Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
  • Able to work upright and stationary for typical working hours.
  • Able to work in non-traditional work environments.
  • Able to use and learn standard office equipment and technology with proficiency.
  • Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
  • May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.
  • This role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains.
  • This position requires overnight travel either regionally or nationally, dependent on business needs.
  • As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.
  • This home-based position requires candidates to currently live in one of the following cities: Sydney, Melbourne, Brisbane, Adelaide or Perth.

Responsibilities

  • Performs and coordinates all aspects of the clinical monitoring and site management process.
  • Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation.
  • Manages procedures and guidelines from a specific sponsor/s and monitoring environment.
  • Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability.
  • Ensures audit readiness.
  • Develops collaborative relationships with investigational sites.
  • Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
  • Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
  • Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
  • Assesses investigational products through physical inventory and records review.
  • Documents observations in reports and letters in a timely manner using approved business writing standards.
  • Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
  • May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
  • Conducts monitoring tasks in accordance with the approved monitoring plan.
  • Participates in the investigator payment process.
  • Ensures a shared responsibility with other project team members on issues/findings resolution.
  • Investigates and follows-up on findings as applicable.
  • Participates in investigator meetings as necessary.
  • Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
  • Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
  • Performs trial close out and retrieval of trial materials.
  • Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
  • Conducts on-site file reviews as per project specifications.
  • Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
  • Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
  • Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
  • Responds to company, client and applicable regulatory requirements/audits/inspections.
  • Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
  • Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
  • Contributes to other project work and initiatives for process improvement, as required.

FAQs

What is the work schedule for the FSP CRA (Level II) position?

The work schedule is standard, Monday to Friday.

Is this position home-based?

Yes, this is a home-based position, but candidates must currently live in one of the following cities: Sydney, Melbourne, Brisbane, Adelaide, or Perth.

What is the salary for the FSP CRA (Level II) role?

The salary for this position is AUD 93,000.

What travel commitments are expected for this role?

This role requires independent travel up to 80%, including traveling in automobiles, airplanes, and trains, as well as overnight travel either regionally or nationally, depending on business needs.

What qualifications are necessary for this position?

A Bachelor's degree in a life-related field or a Registered Nursing certification, or equivalent relevant formal academic/vocational qualification is required.

What type of experience is preferred for this role?

Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to at least 1 year as a clinical research monitor, is preferred.

Are there specific skills that are important for success in this position?

Yes, important skills include proven clinical monitoring skills, understanding of ICH GCP, critical thinking, good communication skills, and strong organizational abilities.

What are the environmental conditions for this job?

The job has office environmental conditions and may have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.

Is a driver's license required for this position?

Yes, a valid driver's license is required.

What are the key responsibilities of the FSP CRA (Level II)?

Key responsibilities include monitoring investigator sites, ensuring compliance with protocols, conducting monitoring tasks, maintaining communication with investigative sites, and ensuring audit readiness among others.

Is Covid-19 vaccination required for this role?

Yes, as a condition of employment with PPD, this role requires that you have received your Covid-19 vaccine and disclose proof of your vaccination status upon employment.

Does Thermo Fisher offer equal employment opportunities?

Yes, Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

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Mission & Purpose

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.