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Dartmouth Health · 2 hours ago

Research Coordinator I - Cancer Center

Lebanon, NH

Full-time

Onsite

New Grad, Entry Level

Dartmouth Health is a prominent healthcare organization seeking a Clinical Research Coordinator I to support clinical trial operations. The role involves assisting with administrative tasks, maintaining essential records, and ensuring compliance with regulatory standards in clinical research.

Health CareHospitalMedical

Responsibilities

May arrange/schedule required appointments

Learns and supports all of aspects of the study operations (subject management/regulatory) with substantial oversight from the investigator or their designee

Primarily supports subject management, such as subject visit preparation, performs data entry in the Clinical Trial Management System (CTMS), scans informed consents into Electronic Medical Record (EMR) and supports data entry needs of the study

Assists with compiling and maintaining essential records and documents required by Dartmouth-Hitchcock Medical Center (DHMC) and various sponsor organizations in compliance with applicable standards operating procedures for the execution of clinical trial operations, including timely Institutional Review Board (IRB) submissions meeting sponsor and departmental requirements

Provides support to supervisor and IRB with regard to regulatory and sponsor-related issues

Assists with maintaining accurate and timely sponsor communications regarding status of research studies

Under the direction of the supervisor, assists DMHC investigators with regulatory processes

Maintains basic current understanding of IRB and Dartmouth-Hitchcock Health (D-HH) Institutional processes

Maintains and tracks on-site and off-site storage of required study records and assists with data entry and accurate use of a tracking system for maintaining required essential documents

Assists with local and commercial IRB, including initial submissions, modifications, renewal applications, and study closeout procedures

Assists with scheduling and coordination of site visits, participates in site visits as assigned and tracks and ensures action items noted during site visits are completed and closed

Tracks all required essential regulatory documents according to International Council on Harmonization (ICH) Good Clinical Practice (GCP) guidelines including but not limited to investigators’ Curriculum Vitae (CVs), medical licenses, Collaborative Institutional Training Initiative (CITI), clinical laboratory certifications, etc

Adheres to the principles for the ethical conduct of research, and safeguards for protection of human subjects especially when conducting research with vulnerable populations

Understands and prioritizes the safety of research participants

Utilizes Electronic Data Capture (EDC) systems, technologies and software necessary for study operations

Completes data entry related to test results and/or measures according to protocol, and appropriate to role. Completes paper and electronic Case Report Forms (CRFs and eCRFs) accurately and according to protocol

Assists with investigating incomplete, inaccurate or missing data and or documents to ensure accuracy and completeness of data; follows Standard Operating Procedures (SOPs) for data quality assurance

Appropriately utilizes standard processes, policies and systems to ensure data integrity, attribution, and security

Understands and demonstrates the professional guidelines and code of ethics related to the conduct of clinical research

Completes all D-H and project-specific training requirements

Assists with administrative tasks associated with clinical research studies (e.g. document and supply management)

Maintains lab kits and creates and maintains regulatory and subject binders

May participate in manuscript/abstract development

Communicates appropriately (written and orally) between stakeholders

Assists with communications between principal investigators, regulatory agencies, D-H stakeholders and study participants to resolve problems

Performs other duties as required or assigned

Qualification

Clinical Trial Management SystemElectronic Data CaptureClinical PracticeHuman Subject ProtectionResponsible Conduct of ResearchBLS certificationData entryCommunication skillsTeam collaboration