Sr CRA

at  Thermo Fisher Scientific

JOB 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. 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.

EDUCATION

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

EXPERIENCE

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years as a clinical research monitor).Valid driver’s license where applicable.
• 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, ABILITIES

• Effective clinical monitoring skills
• Fluency in English and Danish
• Excellent understanding and demonstrated application of FDA guidelines, 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.
• Manages Risk Based Monitoring concepts and processes
• Ability to mentor and train other monitors in a positive and effective manner
• Ability to evaluate medical research data and proficient knowledge of medical terminology
• Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
• Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues
• Excellent interpersonal skills
• Strong attention to detail
• Effective organizational and time management skills
• Ability to remain flexible and adaptable in a wide range of scenarios
• Excellent team player with team-building skills
• Ability to work independently as required
• Ability to utilize problem-solving techniques applicable to constantly changing environment
• Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software
• Effective presentation skills

• 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.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.
• This role requires independent travel up to XX%, inclusive of traveling in automobiles, airplanes, and trains