Clinical Research Coordinator II

Thermo Fisher Scientific•Atlanta, GA

About The Position

The Clinical Research Coordinator II oversees clinical site activities and helps ensure high standards of patient care and data integrity. The role conducts studies in accordance with FDA/GCP and ICH regulations and guidelines, provides medical care with patient safety as the priority, and performs protocol-defined study activities. It also supports study documentation, regulatory compliance, patient scheduling and retention, and accurate, timely entry of information into sponsor systems. Work is performed in an office, laboratory, and/or clinical environment, with occasional domestic or international travel.

Requirements

Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
BLS certificate.
Comparable to 2+ years of previous experience providing the knowledge, skills, and abilities to perform the job.
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 and process sensitive complex information, and solve problems.
Demonstrated 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.
Ability to perform repetitive hand movements and frequent mobility, with occasional crouching and stooping and frequent bending and twisting of the upper body and neck.
Ability to lift and carry light to moderate loads of 15–20 lbs.; the job description also states the ability to lift 40 lbs. without assistance.
Ability to use a variety of in-house and off-the-shelf computer software.
Ability to communicate and understand information presented verbally, interact with diverse groups, perform variable tasks under changing conditions, work under stress, multitask, and maintain regular and consistent attendance.

Nice To Haves

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 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 forms in accordance with the protocol.
Complete investigational product accountability logs and associated 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 as 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 ensure records are current.
Adhere to company COP/SCOP.
Dispose of waste according to standards and help maintain the facility's neat appearance as required.