Clinical Research Coordinator

Thermo Fisher Scientific•Atlanta, GA

15d

About The Position

The Clinical Research Coordinator oversees clinical site activities and helps ensure high standards of patient care and data integrity. The role conducts clinical studies in accordance with FDA/GCP and ICH requirements, provides patient care, carries out study procedures, and maintains accurate study and patient records. The position works in office, laboratory, and/or clinical environments and may involve occasional domestic or international travel.

Requirements

Bachelor’s degree or equivalent and relevant formal academic or vocational qualification.
Previous experience providing relevant knowledge, skills, and abilities comparable to 2+ years.
Solid understanding of the clinical research process, including GCP, SOPs, informed consent, and safety monitoring.
Ability to work independently, analyze information, maintain attention to detail, prioritize sensitive and 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 and ability to work in a team environment.
Regular and consistent attendance.
Ability to work upright and/or stationary for 6–8 hours per day; perform repetitive hand movements; and meet mobility, bending, twisting, and occasional crouching or stooping demands.
Ability to lift and carry objects; the physical requirements specify a maximum of 15–20 lbs, while the work schedule/environment section states ability to lift 40 lbs without assistance.
Ability to communicate and understand information presented verbally, interact with diverse groups, multitask, and perform under stress.

Nice To Haves

BLS certificate preferred.
English fluency is 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 help maximize scheduling capacity.
Perform study activities such as informed consent, screening, 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 patient relationships to support retention.
Attend site initiation and other relevant meetings for protocol training.
Call patients, book appointments, and make follow-up calls to confirm bookings or provide information or results when required.
Enter and complete 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 keep records current.
Adhere to company COP/SCOP.
Dispose of waste according to standards and help maintain the facility’s general appearance when required.