[Hiring] Clinical Research Associate Level II @Thermo Fisher Scientific

Role Description

Join Us as a Clinical Research Associate (Level II) – Make an Impact at the Forefront of Innovation. As part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. 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 in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability.

• Monitors investigator sites with a risk-based monitoring approach.
• Applies root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures and corrective/preventive actions.
• 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 and follows all issues through to resolution.
• Maintains regular contact between monitoring visits with investigative sites to confirm protocol adherence.
• Conducts monitoring tasks in accordance with the approved monitoring plan.
• Participates in the investigator payment process.
• Ensures shared responsibility with other project team members on issues/findings resolution.
• Investigates and follows up on findings as applicable.
• Participates in investigator meetings as necessary.
• Identifies potential investigators in collaboration with the client company.
• Initiates clinical trial sites according to relevant procedures.
• Performs 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 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.
• Facilitates effective communication between investigative sites, the client company, and the PPD project team.
• 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.
• Contributes to other project work and initiatives for process improvement, as required.

Qualifications

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 year as a clinical research monitor) or completion of PPD Drug Development Fellowship.
• At least 1-2 years of independent monitoring experience in clinical development phases I-III.
• Understanding of ICH-GCP, KGCP requirements.
• Fluency in English.

Requirements

• Proven clinical monitoring skills.
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
• Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations, and procedural documents.
• Well-developed critical thinking skills, including critical mindset and 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 good listening skills and attention to detail.
• 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 English language and grammar skills.
• Good presentation skills.