Clinical Research Coordinator III

Thermo Fisher Scientific • Atlanta, GA

2d • Hybrid

About The Position

Join us as a Senior Clinical Research Coordinator – To oversee and manage clinical operations at our research site, ensuring compliance with study protocols and regulatory guidelines, providing training and support to staff, and serving as a liaison between the site and clinical trial sponsors to facilitate successful study execution and patient enrollment.

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.

Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• BLS certificate required.
• Previous experience to provide the knowledge, skills, and abilities to perform the job (comparable to 5+ years’)
• Thorough understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.)
• Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving
• Demonstrated ability to exercise discretion and sound judgement
• Solid decision-making, negotiation and influencing skills
• Strong communication skills and English fluency will be an advantage
• Strong organizational skills
• Strong proficiency in basic computer applications
• Solid interpersonal skills to work in a team environment

Responsibilities

• Conduct clinical studies according to FDA/GCP and ICH regulations and guidelines.
• Provide medical care to patients, always ensuring patient safety comes first.
• Schedule subject visits within protocol windows, ensuring scheduling capacity is maximized.
• Perform all defined study activities (i.e., informed consent, screening, and protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, ECG's, blood samples, etc.).
• Record all patient information and results from test as per protocol on the required forms.
• Where required, may complete IP accountability logs and associated information.
• Report suspected of non-compliance to relevant site staff.
• Ensure that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.
• Promote the company and builds a positive relationship with patients to ensure retention.
• Attend site initiation meetings and all other relevant meetings to receive training on protocol.
• Review the plan for study conduct for multiple assigned studies and determine how to accomplish.
• Identify and communicate any obstacles impeding efficient study conduct.
• Accurately collect and document data.
• Ensure correct study documents and Computer generated forms are used in compliance with protocol.
• Ensure that timelines are met by working with relevant staff.
• Monitor safety and well-being of all study participants through direct and indirect interaction with subjects, and communicate problems to relevant stakeholders.
• Perform clinical assessments of participants, monitor laboratory safety reports, and communicate any serious or potentially serious adverse events as per the company procedure.
• Serve as a primary point of sponsor contact for all research activities for studies assigned.
• Ensure all communications are documented and shared with the appropriate team members.
• Act as a back-up to direct people manager. This includes but is not limited to, overseeing and assigning work to team members, scheduling, and monitoring time.
• Involved in the interview and hiring process of new team members.
• Assist in the training of new team members and providing mentoring.
• Provide input into evaluations performance reviews of team members.
• Perform other study related duties as qualified by documented training.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior