Clinical Research Coordinator II - St. Louis, MO

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 Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.
Summarized Purpose:
Conducts multiple ongoing clinical trials involving patients or healthy volunteers/subjects. Completes all paperwork required to capture all data as specified by a study protocol, and for ensuring subject safety, understanding, and cooperation during the study process. Interacts with the research site team and other interdepartmental staff. Engages in the entire site operations process, which includes recruitment, enrollment, and retention of study participants.

Essential Functions:

• Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.

• Provides medical care to patients, always ensuring patient safety comes first. • Schedules subject visits within protocol windows, ensuring scheduling capacity is maximized.

• Performs 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, etc.).

• Records all patient information and results from tests as per protocol on required forms.  Where required, may complete IP accountability logs and associated information.  Reports suspected non-compliance to relevant site staff. • Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.

• Promotes the company and builds a positive relationship with patients to ensure retention.
• Attends site initiation meetings and all other relevant meetings to receive training on protocol.
• May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results.
• Logs/completes information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe.
• Gathers and maintains source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.
• Adheres to company COP/SCOP.
• May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility.

Job Complexity:
Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
Job Knowledge:
Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
Supervision Received:
Normally receives general instructions on routine work, detailed instructions on new projects or assignments. Exercises judgment within defined procedures and practices to determine appropriate action.
Business Relationships:
Contacts are primarily internal to the company with infrequent external customer / vendor contact on routine matters. Builds productive internal / external working relationships.
Qualifications:

Education and Experience:

• Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
• BLS certificate required.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’).

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:

• Solid 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  Good decision-making, negotiation and influencing skills
• Good communication skills and English fluency will be an advantage
• Good organizational skills
• Good proficiency in basic computer applications
• Good interpersonal skills to work in a team environment

Management Role:
No management responsibility

Working Conditions and Environment:

• Work is performed in an office/ laboratory and/or a clinical environment.

• Exposure to biological fluids with potential exposure to infectious organisms. • Exposure to electrical office equipment.

• Personal protective equipment required such as protective eyewear, garments and gloves.
• Occasional travel, may be domestic or international.

Physical Requirements:

• Ability to 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.
• Ability to communicate 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.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.

Percent Billable: 80% - 100%

Essential Functions:

• Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines

• Records all patient information and results from tests as per protocol on required forms.  Where required, may complete IP accountability logs and associated information.  Reports suspected non-compliance to relevant site staff. • Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.

• Promotes the company and builds a positive relationship with patients to ensure retention.
• Attends site initiation meetings and all other relevant meetings to receive training on protocol.
• May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results.
• Logs/completes information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe.
• Gathers and maintains source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.
• Adheres to company COP/SCOP.
• May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility