Clinical Research Coordinator Sr.

CenExel•Marlton, NJ

3d•Onsite

About The Position

Independently responsible for coordinating all aspects of multiple and/or complex clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies.

Requirements

Must have proper experience and demonstrate mastery of Clinical Research Coordinator II position.
Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials.
Strong leadership and mentorship skills.
Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level.
Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations.
Works independently as well as functioning as part of a team.
Must be able to effectively communicate verbally and in writing.

Nice To Haves

Bachelor's degree, preferred.
CCRC certification preferred.
5 years of experience in the medical field or Masters Degree, preferred.

Responsibilities

Coordinates all aspects of patient involvement for complex and/or multiple studies from study initiation until study completion.
Organizes research information for clinical trials.
Observes subjects and assists with data analysis and reporting.
Oversees study protocol scheduling and collection of data.
Identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately.
Manages, monitors, and reports research data to maintain quality and compliance.
Performs administrative and regulatory duties related to the study as appropriate.
Participates in other protocol development activities.
Works collaboratively with internal departments, sponsors and investigators to ensure protocols are understood and assists in training staff members.
Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.)
Educates potential participants and caregivers on protocol specific details and expectations.
Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned).
Assists senior management with site qualification visits by knowledge of staff credentials, equipment, calibrations, and enrollment capabilities.
Assesses and delegates daily tasks to research staff, ensuring goals of accuracy and timeliness.
Trains, mentors, and/or manages Research Assistants and lower level Clinical Research Coordinators.
Assumes other duties and responsibilities as assigned.