Trial Operations Quality Control Coordinator

COG Research Foundation, LLC Childhood Cancer Research

RemoteFull-TimeMiddle

Salary70296 - 101911 USD per year

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Job Details

Experience: Two (2) years of relevant experience; four (4) additional years of relevant experience can substitute for a Bachelor's degree. Five (5) years of experience involving oncology protocol management, published manuscripts, grants or other documents related to scientific research is highly desired.

Requirements

Two (2) years of relevant experience in quality control and/or clinical trial protocol development
Familiarity with clinical trial components such as IND and IRB process, study methodology, informed consent, eligibility and adverse events
Bachelor’s degree in Life Sciences or a related field (or substitute with four (4) additional years of relevant experience)
Demonstrated success and skill at researching, analyzing, and evaluating scientific information
Ability to work independently as well as collaboratively with staff and investigators
High level of computer literacy, including intermediate to advanced knowledge of Microsoft Word
Excellent verbal and written communications skills
Knowledge of word processing and medical terminology
Clinical research experience in development of investigator initiated trials, management of NCI- sponsored protocols, or related field is desired
Five (5) years of experience involving oncology protocol management, published manuscripts, grants or other documents related to scientific research is highly desired
Master’s degree in Life Sciences or related field is preferred

Responsibilities

Maintain a working knowledge of Protocol Coordinator responsibilities and work instructions
Attend monthly Protocol Coordinator meetings, Quarterly Senior Protocol Coordinator meetings, Monthly Trial Operations meetings, Epi meetings, and monthly ROR Committee meetings
Provide quality control reviews on protocols, informed consent documents (ICDs), and supplemental documents across Leagues, as assigned
Provide feedback on consistency, clarity, and adherence to templates and standards to the assigned Protocol Coordinator for incorporation into protocols and related documents
Serve as the subject matter expert in the creation of Informed Consent Forms and Therapy Delivery Maps consistent with the organization’s standards
Present quality control review findings or issues regarding consistency and/or clarity in protocols, ICDs and other study documents to improve processes and templates
Provide quality control reviews of the weekly postings for consistency, clarity, and adherence to templates and standards to the Protocol Coordinator, Research Coordinator and the League Administrative Coordinators
Train new Protocol Coordinators and Research Coordinators in the weekly Protocol Posting Process
Assist the League Directors in the development and maintenance of departmental templates and SOPs
Provide coverage for Protocol Coordinators as assigned, based on temporary needs across leagues
Serve as the Protocol Coordinator of Epi trial proposals utilizing future contact consent
Represent Operations team on the Return of Results committee
Escalate questions or information to League Directors as appropriate
Travel to COG Group Meetings as needed to provide Protocol Coordinator coverage and attend Epi and Return of Results committee meetings
Perform related duties as required or assigned

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