[Hiring] FSP CRA (Level 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. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.

Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Summarized Purpose:

• 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.
• Ensures audit readiness and develops collaborative relationships with investigational sites.
• Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

Key responsibilities:

• 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.
• 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.
• Maintains regular contact between monitoring visits with investigative sites.
• Conducts supervising 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 vital.
• Identifies potential investigators in collaboration with the client company.
• Initiates clinical trial sites according to the relevant procedures.
• Performs trial close out and retrieval of trial materials.
• Ensures that required crucial documents are complete and in place.
• Conducts on-site file reviews as per project specifications.
• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM).
• 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.
• Valid driver's license where applicable.

Requirements

• Proven clinical monitoring skills.
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
• Demonstrated ability to attain and maintain a solid understanding 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 manage Risk Based Monitoring concepts and processes.
• Good oral and written communication skills.
• 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 digital literacy: solid knowledge of Microsoft Office and the ability to learn appropriate software.
• Good English language and grammar skills.
• Good presentation skills.

Benefits

• Competitive remuneration.
• Annual incentive plan bonus.
• Healthcare and a range of employee benefits.
• Employment with an innovative, forward-thinking organization.
• Outstanding career and development prospects.
• Exciting company culture that stands for integrity, intensity, involvement, and innovation.