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About the Role
As part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level I), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure 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. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities outlined in the task matrix.
Responsibilities
- Monitors investigator sites with a risk-based monitoring approach, applying root cause analysis, critical thinking, and problem-solving skills to identify site processes failures and corrective/preventive actions.
- Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
- Assesses 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 follows all issues through to resolution.
- Maintains regular contact between monitoring visits with investigative sites to confirm protocol adherence, issue resolution, and timely data recording.
- Conducts monitoring tasks in accordance with the approved monitoring plan.
- Participates in the investigator payment process.
- Ensures 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 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 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 and completes administrative tasks such as expense reports and timesheets in a timely manner.
- Contributes to the project team by assisting in the preparation of project publications/tools, and sharing ideas/suggestions with team members.
- Contributes to other project work and initiatives for process improvement, as required.
Requirements
- Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
- Valid driver's license where applicable.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 year as a clinical research monitor) or completion of PPD Drug Development Fellowship.
- 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.
Skills
- 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 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 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
Location
- Melbourne
- Sydney
- Brisbane
Work Type
- Office
- Remote
- On-site
Experience Level
- 1 year as a clinical research monitor
Education Level
- Bachelor's degree in a life sciences related field
- Registered Nursing certification
Benefits
- Comprehensive benefits
- Wellness programs
- Employee Assistance Program
- Flexible arrangements
- Generous leave policies
- Option to purchase additional leave
- Paid birthday leave
- Company paid parental leave
- Paid volunteer time to support non-profit organizations
- Access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning
- Workshops
- Mentorship programs
About the Company
- Thermo Fisher Scientific's mission is to enable customers to make the world healthier, cleaner and safer.
- As one team of 125,000+ colleagues, we share common values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.
- Diverse experiences, backgrounds and perspectives are valued.
Equal Opportunity
- 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.