Clinical Research Coordinator

ThermoFisher Scientific; Atlanta (GA); Vor Ort; USD 55.000 - 75.000; Vollzeit

Zusammenfassung

Thermo Fisher Scientific is seeking a Clinical Research Coordinator II to oversee site activities and uphold patient care and data integrity in a lab/office setting. You will conduct FDA/GCP/ICH-compliant studies, manage visits, consent, and protocol procedures while safeguarding patient safety and trial quality.

This role requires a bachelor’s degree (or equivalent), preferred BLS, and 2+ years of related experience; strong organization, communication, and attention to detail are essential for

Qualifikationen

• Bachelor's degree or equivalent required; relevant formal academic qualification preferred
• BLS certificate preferred
• 2+ years’ experience in clinical research or related field
• In some cases, equivalency of education/training/experience may be considered

Aufgaben

• Oversee clinical site activities per FDA/GCP/ICH regulations
• Provide medical care prioritizing patient safety
• Schedule subject visits within protocol windows
• Perform study activities including informed consent, screening, vital signs, ECGs and other procedures
• Record patient information and test results on required forms
• Maintain source documents and sponsor system data with accuracy
• Ensure IRB approval and ongoing compliance
• Promote company and maintain patient retention
• Attend site initiation and protocol training meetings
• May perform patient calls or bookings and follow-ups
• Log data in EDC and CRF, ensuring timely completion
• Dispose of waste per standards and maintain clean facility

Kenntnisse

Clinical research process

Independent work

Attention to detail

Discretion

Decision making

Communication

Organization

Computer proficiency

Interpersonal skills

Ausbildung

Bachelor's degree or equivalent

BLS certification preferred

2+ years of experience

Jobbeschreibung

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Join us as a Clinical Research Coordinator II - And play a key role in overseeing clinical site activities and ensuring high standards of patient care and data integrity.

What You’ll Do:

• 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 are not limited to vital signs, pregnancy tests, height, weight, ECG's, etc.).
• Record 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 with 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.
• Attend 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/complete 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.
• Gather and maintain source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.
• Adhere 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.

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• BLS certificate preferred.
• Previous experience to provide 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

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 is 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.

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.

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.