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City of Hope · 7 hours ago

Clinical Study Coordinator

Newnan, GA

Full-time

Onsite

Entry, Mid Level

$28/hr - $47/hr

2+ years exp

City of Hope is one of the largest and most advanced cancer research and treatment organizations in the U.S. They are seeking a Clinical Study Coordinator to support clinical trials for oncology therapies, ensuring compliance with protocols and regulations while coordinating care for research subjects.

AssociationEducationHealth Care

Comp. & Benefits

Responsibilities

Supporting clinical trials at the top of their scope for existing and novel oncology therapies

Coordinating all aspects of therapeutic trials in various oncology disease areas

Demonstrating an in-depth knowledge of applicable federal regulations, institutional guidance documents and SOPs for the conduct of clinical trials

Collaborating with Investigators in review of subjects’ recruitment and pre-screening efforts for protocol eligibility

Developing an individualized strategy for recruitment and retention of assigned trials

Presenting trial concepts and details to research subjects and participating in the informed consent process

Enrolling and coordinating care of subjects in compliance with protocol requirements

Providing education on investigational agents/devices to research subjects and maintaining test article accountability

Monitoring subjects for changes in condition, adverse events, concomitant medication use, protocol compliance, response/reactions to test articles, and thoroughly documenting all findings

Ensuring accurate and timely data collection, documentation, and reporting

Scheduling and/or participating in off-site investigator meetings, pre-site selection visits, site-initiation visits, site-assessments, monitoring visits, and auditing activities as delegated

Assisting with completion and maintenance of regulatory documents in accordance with regulations, hospital and organizational policies and Standard Work Instructions

Participating in required training and education programs and providing clinical research education to local clinic staff

Ensuring site research quality by practicing in compliance with policies, SWIs, principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations

Developing or assisting with development of study tools for therapeutic trials including source documents, eligibility checklists, and criteria cards

Involved in the collection, processing, and shipping of protocol required lab specimens

Maintaining adequate supplies to conduct the studies and ordering replacements as needed

Maintaining the equipment inventory (per protocol) and having appropriate certifications as required by protocol activities

Assisting clinicians (LVN/LPNs, MAs, and/or RNs) as needed to ensure that protocol-required specimen collections, electrocardiograms, vital signs, study drugs dispensation, as well as follow-up observations are performed per protocol

Qualification

Clinical trial coordinationOncology experienceClinical Practice (GCP)ACRPSOCRA certificationHuman Subjects Protection (HSP)Basic Life Support (BLS)International Air Transport Association (IATA)Data collectionRegulatory compliancePatient recruitmentCollaboration with investigatorsDocumentation

Required

Bachelor's degree in Science, Health or related field from an accredited university; 3 additional years of experience plus the minimum experience requirement may substitute for minimum education

Minimum of 2 years research or relevant clinical experience

ACRP or SOCRA certification within 1 year of employment

International Air Transport Association (IATA) within 1 month of employment

Good Clinical Practice (GCP) within 1 month of employment

Human Subjects Protection (HSP) within 1 month of employment

Basic Life Support (BLS) within 1 month of employment