Clinical Research Coordinator I

CenExel•Evesham Township, NJ

13d•$26 - $33

About The Position

The Clinical Research Coordinator I assists with coordinating clinical trials while adhering to ICH, GCP, study protocols, and company guidelines, regulations, and policies. The role supports patient involvement throughout each study, organizes trial information, observes participants, assists with data analysis and reporting, and helps maintain research quality and compliance. It also includes administrative and regulatory work, participant education, protocol-related activities, and safety and efficacy assessments as assigned. The position is based in an indoor office environment and may involve shift work depending on location. Essential activities include sitting, typing, standing, and walking. The role is lightly active, with occasional lifting of up to 20 pounds and rare lifting of more than 20 pounds. Overnight travel may be required for training or investigative meetings, and reporting to work as scheduled is essential.

Requirements

High school graduate or equivalent.
0–3 years of experience in the medical field.
Knowledge and understanding of federal regulations protecting human subjects in research and governing clinical trials.
Strong leadership and mentorship skills.
Ability to develop and maintain effective working relationships at all levels of the organization and with sponsors and vendors.
Crisis management and problem-solving skills, including the ability to react calmly and effectively in emergent situations.
Ability to work independently and as part of a team.
Effective verbal and written communication skills.
Ability to meet the position's physical requirements, including sitting, typing, standing, walking, and occasional lifting of up to 20 pounds.

Nice To Haves

Bachelor’s degree.

Responsibilities

Assist with coordinating all aspects of patient involvement from study initiation through study completion.
Organize research information for clinical trials.
Observe subjects and assist with data analysis and reporting.
Schedule data collection.
Document adverse events, protocol deviations, and other unanticipated problems appropriately.
Report research data to maintain quality and compliance.
Perform administrative and regulatory duties related to studies as appropriate.
Participate in other protocol development activities.
Ensure the site receives accurate information and supplies from sponsors, including source documents, protocols, scales, supplies, approvals, and contacts.
Educate potential participants and caregivers about protocol-specific details and expectations.
Perform safety and efficacy assessments according to protocol, including vital signs, EKGs, blood draws, and other assigned assessments.
Assume other duties and responsibilities as assigned.