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Medix™ · 1 week ago

Senior Clinical Research Coordinator/Trial Manager - 247540

Southfield, MI

Full-time

Onsite

Senior Level

$72K/yr - $80K/yr

5+ years exp

Medix™ is a company focused on clinical research, and they are seeking a Senior Clinical Research Coordinator/Trial Manager. The role involves coordinating complex activities related to clinical research protocols, ensuring compliance with regulations, and maintaining accurate documentation throughout the trial phases.

CrowdsourcingRecruitingSocial NetworkStaffing AgencyVenture Capital

Hiring Manager

Ashley Kaufman

Responsibilities

Read, understand, and can accomplish protocol specified patient visits and procedures

Clearly and concisely document patient assessments, observations, test results and other study related information per federal regulations, protocol requirements and GCPs

Obtain patient informed consent according to federal regulations, GCPs and IRB requirements

Is creative and diligent in recruiting qualified study subjects into assigned protocols to fulfill enrollment obligations within the sponsor’s timeline while following regulations and rules governing medical ethics, IRB, GCP and ICH guidelines

Complete all required training in a timely manner

Schedule and conduct patient visits according to protocol requirements and timelines

Maintain accurate and complete written source documentation of patient visits and protocol related activities

Accurately complete case report forms (CRFs &/or eCRFs) and/or worksheets generated by the sponsor

Maintain confidentiality of patient and protocol issues as appropriate and as bound by Confidentiality Agreements with company, between company and sponsors, and between company and other entities, as well as HIPAA regulations

Promptly report adverse events to supervisor and/or Principal Investigator/Sub-Investigator as deemed necessary

Report Serious Adverse Events (SAEs) to sponsor within 24 hours of becoming aware of the SAE. Also report the SAE to the supervisor, Principal Investigator and/or Sub-Investigator

Account for clinical trial materials (i.e., CRFs, study drug, lab supplies, and/or other required items) and ensure availability of appropriate amounts for the conduct of the study

Maintain ongoing communication with team manager; Principal Investigator; Sub-Investigators and other persons assisting with the trial and document these communications according to protocol requirements and company policies

Attend required training courses/conferences in order to stay abreast of current and changing federal regulations and company policies

Pursue educational opportunities to increase knowledge of the research process and associated rules and regulations governing clinical research

Attend Investigator Meetings and/or other trainings as directed

Perform all study-related duties in a time- and cost-effective manner in adherence with company policies

Represent the company in a professional and courteous manner (verbal, written and in appearance) when interacting with company staff, sponsors, IRBs, patients/subjects, nursing and medical staff members of various clinics, hospitals, and physician’s offices

Additional duties as assigned by management

Qualification

Clinical Research CoordinationClinical Practices (GCP)Informed Consent ProceduresData DocumentationPatient RecruitmentCommunication SkillsTeam CollaborationTime Management