As a Senior Clinical Research Associate (Level II), 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 -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 and client company personnel.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.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 maintat 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 applicableProvides updates on potential trends noted across multiple sites and discusses potential strategies for their management to the Clinical Team Manager (CTM).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 ording to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.Contributes to the project team by mentoring new members, assisting in preparation of project publications/tools including informed consents, CRF guidelines and monitoring plans, and sharing ideas/suggestions with team members. Assists in project specific training for the clinical team where necessary. Identifies areas for potential process improvements & share potential solutions for improvements.Performs additional tasks as assigned by CTM or Clinical Manager of CRAs (CM-CRA) (e.g. trip report review, newsletter creation, lead CRA team calls etc).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). Perform QC check of reports generated from CTMS system where required.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 federal regulatory requirements/audits.Maintains & completes administrative tasks such as expense reports and timesheets in a timely mannerEducationBachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.Valid driver's license where applicable.ExperiencePrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years as a clinical research monitor).sisting 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, AbilitiesEffective clinical monitoring skillsExcellent understanding and demonstrated application of FDA guidelines, ICH GCPs, applicable regulations and procedural documentsWell-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.Manages Risk Based Monitoring concepts and processesAbility to mentor and train other monitors in a positive and effective mannerAbility to evaluate medical research data and proficient knowledge of medical terminologyEffective oral and written communication skills, with the ability to communicate effectively with medical personnelAbility to maintaention to detail and the ability to perceive customers’ underlying issuesExcellent interpersonal skills and strong attention to detailAbility to remain flexible and adaptable in a wide range of scenariosExcellent team player with team building skillsAbility to work independently as requiredPhysical Requirements / Work EnvironmentWork is performed in an office/laboratory/clinical/and/or home office environment with exposure to electrical office equipment.Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals.May also include extended overnight stays.Exposure to biological fluids with potential exposure to infectious organisms.Personal protective equipment required such as protective eyewear, garments and gloves.Exposure to fluctuating and/or extreme temperatures on rare occasions.Must be able to comply with specific sponsor/client/site requirements, even if not required byBenefitsJoin 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 Linkedkshops, and mentorship programs for continuous learning and skill development.Thermo Fisher Scientific Australia WGEA Employer of Choice for Gender EqualityOur 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,
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