Clinical Research Coordinator

Thermo Fisher Scientific•Atlanta, GA

13d

About The Position

The Clinical Research Coordinator oversees clinical site activities and supports patient care and data integrity. The role conducts clinical studies in accordance with FDA/GCP and ICH regulations and guidelines, provides medical care with patient safety as the priority, and carries out study procedures and documentation. The coordinator works with patients, site staff, institutional review boards (IRBs), and sponsors to ensure study requirements are met and information is complete and accurate. Work is performed in an office, laboratory, and/or clinical environment, with exposure to biological fluids and potential infectious organisms, electrical office equipment, and required personal protective equipment. Occasional domestic or international travel may be required. The standard schedule is Monday through Friday.

Requirements

Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 2+ years; an appropriate combination of education, training, and/or directly related experience may be considered equivalent.
Solid understanding of the clinical research process, including GCP, SOPs, informed consent, and safety monitoring.
Ability to work independently, analyze information, attend to detail, process and prioritize sensitive complex information, and solve problems.
Ability to exercise discretion and sound judgment.
Good decision-making, negotiation, and influencing skills.
Good organizational skills.
Good proficiency in basic computer applications.
Good interpersonal skills for working in a team environment.
Ability to work upright and/or stationary for 6–8 hours per day; perform repetitive hand movements; maintain frequent mobility; and occasionally crouch or stoop, with frequent bending and twisting of the upper body and neck.
Ability to lift and carry light to moderate loads, including luggage and a laptop, with a stated maximum of 15–20 lbs.
Ability to perform variable tasks under changing conditions, manage stress, multitask, and maintain regular and consistent attendance.
Ability to access and use in-house and off-the-shelf computer software and to communicate and understand information conveyed verbally.
Ability to interact frequently with others to obtain or convey information to diverse groups.

Nice To Haves

BLS certificate preferred.
English fluency will be an advantage.

Responsibilities

Conduct clinical studies according to FDA/GCP and ICH regulations and guidelines.
Provide medical care to patients while prioritizing patient safety.
Schedule subject visits within protocol windows and maximize scheduling capacity.
Perform study activities, including informed consent, screening, and protocol procedures such as vital signs, pregnancy tests, height and weight measurements, and ECGs.
Record patient information and test results on required protocol forms.
Complete investigational product accountability logs and related information where required.
Report suspected non-compliance to relevant site staff.
Ensure IRB approval is obtained before study initiation and that IRB requirements are met throughout the study.
Promote the company and build positive relationships with patients to support retention.
Attend site initiation and other relevant meetings to receive protocol training.
Call patients, book appointments, and make follow-up calls to confirm bookings or provide information or results when required.
Enter and maintain accurate information in sponsor systems, including case report forms and EDC, within required timeframes.
Gather and maintain source documents, update patient files and notes, and ensure records are current.
Adhere to company COP/SCOP.
Dispose of waste according to standards and help maintain the facility’s neat appearance when required.