Clinical Research Associate I

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

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 be resident in New Zealand, located within proximity of a well-connected air travel hub.

What you'll do

• 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.
• 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.
• May participate in investigator meetings as necessary. Initiates clinical trial sites to ensure compliance.
• Performs trial close out and retrieval of trial materials. Conducts on-site and remote file reviews.
• 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.
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
• Job Complexity; works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
• Job Knowledge; learns to use professional concepts. Applies company policies and procedures to resolve routine issues.
• Supervision Received; normally receives detailed instructions on all work.
• Business Relationships; contacts are primarily with immediate supervisor, and other personnel in the department. Builds stable working relationships internally.

Education

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

Experience

• Previous Clinical trial monitoring experience preferred.
• 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.
• Valid New Zealand driver's license.
• 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.

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
• Good IT literacy skills, e.g., MS Word, Excel, Outlook, Power Point
• 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

Other Important Information

• Occasional off-hours support or project-based flexibility may be required to support critical activities such as commissioning or equipment start-ups.

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.

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 125,000+ 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 at 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.