Sr CRA (Level I)

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. 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.

Ideal candidates will possess four or more years of onsite monitoring experience and have experience monitoring oncology. This position requires overnight travel either regionally or nationally dependent on business needs.

Discover Impactful Work:

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 different sponsors and/or monitoring environments (i.e. FSO FSP Government etc.). 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. Ensures data accuracy through SDR SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product 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
• 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 CTMS). Performs QC check of reports generated from CTMS system where required.
• 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. Ensures 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.
• Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review newsletter creation lead CRA team calls etc).
• 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 other project work and initiatives for process improvement as required.

Keys to Success:

Education and Experience:

• Bachelors degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
• Minimal 4 years experience independant monitoring experience in Australia that provides the knowledge skills and abilities to perform the job (comparable to 2 years as a clinical research monitor).
• Valid drivers license where 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.
• Therapeutic experience in Oncology essential
• Phase I experience essential

Knowledge Skills and Abilities:

• Effective clinical monitoring skills
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
• Excellent understanding and demonstrated application 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 manages Risk Based Monitoring concepts and processes
• Effective 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
• Effective interpersonal skills
• Strong attention to detail
• Effective organizational and time management skills
• 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: proficient knowledge of Microsoft Office and the ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills
• Australian citizenship or permanent residency 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 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.

Benefits

We offer competitive remuneration annual incentive plan bonus and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!