Sr. CRA

Job Description

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 with 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!

Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and leads documentation. Leads procedures and guidelines from sponsors and/or monitoring environments. 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 to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites and client company personnel. May assist project manager or clinical team manager on assigned projects and/or may assist in the mentoring and training of team members. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

Education and Experience:

• Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent formal academic / vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years as a clinical research monitor).
• 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 and Abilities:

• Effective clinical monitoring skills
• 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.
• Leads Risk Based Monitoring concepts and processes
• Mentor and train other monitors in a positive and effective manner
• Evaluate medical research data and proficient knowledge of medical terminology
• Effective verbal and written communication skills, with the ability to connect with medical personnel
• Ability to maintain customer focus through the utilization of listening skills, attention to detail and the ability to perceive customers’ underlying issues
• Can work independently and apply problem-solving techniques applicable to constantly evolving environment
• Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software

Working Conditions and Environment:

• Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.
• 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.

Physical Requirements:

• Work in an upright and /or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Frequent mobility required. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others to obtain or relate information to diverse groups.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.