Clinical Research Coordinator I

CenExel•Gaithersburg, MD

10d•Onsite

About The Position

Responsible for assisting with coordinating clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies.

Requirements

High school graduate or equivalent; Bachelors Degree, preferred.
0-3 years of experience in the medical field.
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

Responsibilities

Assists with coordinating all aspects of patient involvement 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.
Documents adverse events, protocol deviations, and other unanticipated problems appropriately.
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).
Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.