Clinical Research Coord I

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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.
 

Summarized Purpose:

Conducts at least one ongoing clinical trial that may involve patients or healthy volunteers. Interacts with the research site team and interdepartmental staff to ensure positive interactions with patients  at site for study planning, from initiation to closeout.

Essential Functions and Other Job Information:

Conduct clinical studies in strict adherence to FDA/GCP and ICH regulations, ensuring patient safety and providing medical care to patients. Perform study activities, including informed consent, screening, and protocol procedures (vital signs, pregnancy tests, height, weight, ECGs). Accurately record patient information and test results, complete IP accountability logs, and report non-compliance. Ensure IRB approval and compliance, promote the company, and build positive patient relationships. Manage patient bookings, follow-up calls, and log information on sponsor systems. Gather source documents, update patient files, and adhere to company standards while maintaining a neat facility appearance.

Bachelor’s degree or equivalent experience in a clinical/medical field along with a BLS certificate is mandatory. Prior experience (0 to 2 years) demonstrating the necessary knowledge, skills, and abilities for the role is essential. Consideration will be given to those with a comparable combination of education, training, and/or directly relevant experience.

Proficiencies and aptitudes:

A basic understanding of clinical research processes, including GCP, SOPs, informed consent, and safety monitoring, is essential. The capability to work autonomously, evaluate data, and prioritize intricate information with meticulousness is required. Proven ability to exercise discretion and good judgment, along with adequate decision-making, negotiation, and influencing skills, is necessary. Strong communication skills and proficiency in English are advantageous, as are excellent organizational skills. Proficiency in basic computer applications and strong interpersonal skills to work effectively in a team environment are also important.

Working Conditions and Environment:

• Work performed in office, laboratory, and/or clinical environments.
• Exposure to biological fluids and potential infectious organisms.
• Exposure to electrical office equipment.
• Use of personal protective equipment like protective eyewear, garments, and gloves is required.
• Occasional domestic or international travel.

Physical Requirements:

• Capability to remain in a vertical or fixed position for 6-8 hours daily.
• Repetitive hand movements with the ability to make fast, simple, repeated movements.
• Frequent mobility required.
• Occasional crouching, stooping, and frequent bending and twisting of the upper body and neck.
• Ability to lift and carry objects, including luggage and laptop computers, up to 15-20 lbs.
• Ability to use various computer software applications.
• Strong ability to communicate and understand information and ideas.
• Interact frequently with diverse groups to acquire or relay information.
• Ability to perform under stress and multitask.
• Regular and consistent attendance is essential.