FSP CRA (Level I) in Melbourne, Australia

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

Discover Impactful Work:

Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from a sponsor (FSP). 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.

A day in the Life:

• 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.

• Assess investigational product through physical inventory and records review.

• Raises 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 identified issues are being resolved and that the data is being recorded.

• Participates in investigator meetings. Initiates clinical trial sites to ensure compliance.

• Performs trial close out and retrieval of trial materials. Conducts on-site file reviews.

Keys to Success:

Education

• Bachelor’s degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.

Experience

• Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) in a clinical environment where experience is gained in clinical trials may be considered.

• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

• Valid driver’s license.

Knowledge, Skills, Abilities

• Ability to attain and maintain a solid understanding of ICH GCPs and applicable regulations and procedural documents

• 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 and attention to detail

• Good organizational and time management skills

• Ability to remain flexible and adaptable in a wide range of scenarios

• Well-developed critical thinking skills and problem solving

• Ability to manage Risk Based Monitoring concepts and processes

• Ability to work in a team or independently as required

Work Environment

Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• 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 balancing 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.

Location/Division Specific Information

Performs and coordinates different aspects of the clinical monitoring and site management process. This home-based position requires candidates to currently live in one of the following cities: Sydney, Melbourne, Brisbane, Adelaide or Perth.

Apply today! http://jobs.thermofisher.com

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

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values – Integrity, Intensity, Innovation and Involvement – working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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