[Hiring] Clinical Research Associate II @Thermo Fisher Scientific

Role Description

At 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.

• Performs and coordinates different 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.
• 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.
• Develops collaborative relationships with investigational sites and client company personnel.
• Assists project manager or clinical team manager on assigned projects and will take a lead role where required.
• Supports the line manager to mentor, train and contribute to the development of junior clinical team members.
• Monitors investigator sites with a risk-based monitoring approach.
• Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
• Documents observations in reports and letters in a timely manner using approved business writing standards.
• Escalates observed deficiencies and issues to clinical management expeditiously.
• Conducts monitoring tasks in accordance with the approved monitoring plan.
• Ensures a shared responsibility with other project team members on issues/findings resolution.
• 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.
• Participates in investigator meetings as necessary.
• Initiates clinical trial sites according to the relevant procedures.
• Ensures trial close out and retrieval of trial materials.
• Conducts on-site file reviews as per project specifications.
• Facilitates effective communication between investigative sites, the client company and the PPD project team.
• 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.

Qualifications

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

Requirements

• Considerable clinical research monitoring experience (comparable to 5+ years).
• Expert clinical monitoring skills.
• Expert knowledge of FDA guidelines, ICH GCPs, applicable regulations and procedural documents.
• Excellent critical thinking skills, including root cause analysis and problem solving.
• Proficient in Risk Based Monitoring concepts and processes.
• Demonstrated ability to evaluate medical research data and proficient knowledge of medical terminology.
• Excellent oral and written communication skills.
• Ability to maintain customer focus.
• Excellent interpersonal skills.
• Excellent organizational and time management skills.
• Strong attention to detail.
• Ability to remain flexible and adaptable in a wide range of scenarios.
• Effective presentation skills.
• Good digital literacy: proficient knowledge of Microsoft Office.

Benefits

• Competitive remuneration.
• Annual incentive plan bonus.
• Healthcare.
• A range of employee benefits.
• Outstanding career and development prospects.
• Exciting company culture that stands for integrity, intensity, involvement, and innovation.