Job detail

Clinical Research Coordinator II

CenExel

#EKGs #Blood Draws #GCP #Data Collection #ICH #Psychiatry #Clinical Trials #Neurology #Adverse Events #Protocol Deviations

Quick overview

The coordinator is responsible for managing all phases of clinical trials from initiation to completion, ensuring strict adherence to ICH, GCP, protocol, and company guidelines. This includes organizing research information, monitoring subjects, performing safety assessments, and handling administrative and regulatory duties.

Requirements summary

Candidates must demonstrate mastery of the Clinical Research Coordinator I position, typically requiring 2-3 years of experience in the medical field, though a Bachelor's degree and CCRC certification are preferred. Essential skills include strong leadership, effective communication, problem-solving abilities, and deep knowledge of federal regulations protecting human research subjects.

high schoolbachelor degreeQuality AssuranceCommunicationProblem SolvingData AnalysisLeadershipStaff TrainingRecruitmentVendor OversightProtocol AdherenceMentorshipICH ComplianceProtocol DevelopmentClient SatisfactionAdverse Event ReportingRegulatory DutiesGCP Compliance

Job description

About Us

Each of CenExel’s research sites specialize in Phase I to Phase IV clinical trials.
Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country.
Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology.
Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability.
We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.

Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.

Job Summary

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.

Essential Responsibilities and Duties

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.

Clinical Research Coordinator II

Quick overview

Requirements summary

Job description

About Us

Job Summary

Essential Responsibilities and Duties

Benefits

Education/Experience/Skills

Working Conditions

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