Clinical Research Coordinator

JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join us as a Clinical Research Coordinator I – To coordinate and manage clinical trials, ensuring adherence to protocols, regulatory requirements, and timelines while working closely with the clinical team to support patient recruitment, data collection, and documentation efforts for advancing medical research.

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.

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.
• 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.).
• Phlebotomy and sample processing/shipping

• Record all patient information and results from tests as per protocol on 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 build 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.
• Log/complete information on sponsor systems and ensure all information provided is accurate (i.e., case report forms, EDC, etc.) and ensure it is completed within timeframe.
• Gather source documents, update 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 in the clinical / medical field
• BLS certificate required.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 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:
• Basic 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
• Adequate decision-making, negotiation and influencing skills
• Decent communication skills and English fluency will be an advantage
• Decent organizational skills
• Essential proficiency in basic computer applications
• Decent 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.
• Accelerated Enrollment Solutions is a business unit of Pharmaceutical Product Development, LLC, a Delaware limited liability company (“PPD”),
collectively made up of Acurian, Inc. and Synexus, each a subsidiary of PPD.

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.

Apply today to help us deliver tomorrow’s breakthrough.

Compensation and Benefits

The hourly pay range estimated for this position based in Minnesota is $26.00–$29.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: