Clinical Research Coordinator - Clinical Research

CenExel•Savannah, GA

1d•$25 - $29•Onsite

About The Position

This position is responsible for coordinating all aspects of clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. The role involves managing patient involvement from study initiation to completion, organizing research information, observing subjects, assisting with data analysis, scheduling data collection, and reporting adverse events and protocol deviations. The coordinator will also monitor and report research data for quality and compliance, perform administrative and regulatory duties, participate in protocol development, ensure the site receives accurate information and supplies from sponsors, and educate participants and caregivers on protocol details. Additionally, the role includes performing safety and efficacy assessments, and assisting the Clinical Trial Manager (CTM) with vendor oversight, accounting, regulatory matters, client satisfaction, recruitment, quality, and trial outcomes, as well as planning, process creation, training, and staff development.

Requirements

Must have experience and demonstrate mastery of a Clinical Research Coordinator position.
High school graduate or equivalent
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

Bachelors Degree, preferred
CCRC certification preferred
2-3 years of experience in the medical field, preferred

Responsibilities

Under supervision, coordinates 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.
Schedules the collection of data.
Reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately.
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.
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 Clinical Trial Manager (CTM) with oversight of vendors, accounting, regulatory, client satisfaction, recruitment, quality, and trial outcomes.
Assists the CTM in planning, creating processes, trainings and development of staff.
Assumes other duties and responsibilities as assigned.