Senior Clinical Research Associate (Cell & Gene - FSP)

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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.

Location Information

This is a home-based position and preferably based in Sydney or Melbourne

Key responsibilities

• 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 supervising 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 vital. 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 crucial 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.

Education and Experience:

• Bachelor's degree in a life sciences-related field, Registered Nursing qualification, or an equivalent relevant academic or vocational qualification.
• Previous experience demonstrating the knowledge, skills, and abilities required to perform the role, equivalent to at least one year of experience as a Clinical Research Monitor.
• Experience in Cell and Gene Therapy (CGT) is mandatory for this position.

Knowledge, Skills and Abilities:

• Proven clinical monitoring skills.
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
• Demonstrated ability to attain and maintain a solid understanding 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 digital literacy: solid 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

Benefits

Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer. 

• Health & Wellbeing: Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues. 

• Flexibility: Balance your work and personal life with flexible arrangements. 

• Extra Leave: Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave. 

• Charitable Giving & Volunteering: Make an impact with paid volunteer time to support non-profit organizations that matter to you. 

• Learning & Development: Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development. 

Thermo Fisher Scientific Australia WGEA Employer of Choice for Gender Equality 

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!