Senior Clinical Research Associate (Remote) | Expression of Interests

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 with at least 3 years within New Zealand. Experience in Phase I Healthy Volunteers studies/Early Developmental Studies is essential for consideration. This position requires travel 60%-70% and occasionally overnight nationally but occasionally internationally dependent on business needs.

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 permanent resident/citizens located in New Zealand located within proximity of a well-connected air travel hub ideally in Auckland.

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. 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.
• Maintains 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.
• May participate 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 and remote 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. Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 4 years as a clinical research monitor). Monitoring experience in phase-I healthy volunteers studies is essential.
• Valid New Zealand drivers license is required and ability to drive.
• 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 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

Physical Requirements / 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.
• This role requires independent travel up to 60% inclusive of traveling in automobiles airplanes and trains.
• 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.
• You must possess unrestricted work rights i.e. NZ Citizen and/or Permanent Resident or equivalent

Our Mission is to enable our customers to make the world healthier cleaner and safer. As one team of 125000 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.

This position will also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy.

Apply today!

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.