Research Coordinator II - Cancer Center

Dartmouth-Hitchcock Health•Lebanon, NH

40d

About The Position

The Clinical Research Coordinator II performs clinical research duties at a skilled level, applying working knowledge of the clinical research process and governing regulations. The role performs progressively more complex and comprehensive duties with increasing independence while working closely with the Principal Investigator (PI). The coordinator works under the supervision and direction of the PI or their designee and may not perform tasks that state or local law requires a license to perform. The position supports study operations, including participant management, regulatory documentation, data collection and quality, research ethics and safety, and study-site management. It serves as a liaison among investigators, regulatory agencies, organizational stakeholders, and study participants. Some duties may occur outside defined operating hours, and travel may be required.

Requirements

Bachelor's degree and 2 years of relevant research experience, or equivalent years of experience.
Ability to travel as required.
BLS certification required within 30 days of hire.
Human Subject Protection, Responsible Conduct of Research, and Good Clinical Practice certificates required within 30 days of hire.

Nice To Haves

SOCRA or ACRP certification, or eligibility for certification.

Responsibilities

Arrange and/or schedule required tests and other appointments.
Support study operations, including participant management and regulatory activities, with oversight from the investigator or designee.
Perform participant-management tasks such as entering data in the Clinical Trial Management System, scanning informed consents into the electronic medical record, and supporting study data-entry needs.
Carry out study-visit tasks, such as administering Quality of Life questionnaires, under investigator supervision.
Interview participants about medical history, medications, adverse events, demographics, and quality-of-life issues as appropriate to study complexity, with PI review and source data informed by medical records.
Communicate with participants during the study and provide education and support to participants and their families.
Prepare and submit regulatory documents to study sponsors and applicable regulatory agencies.
Maintain study and regulatory documentation and manage tasks involving Institutional Review Boards, sponsors, and Dartmouth-Hitchcock Medical Center regulatory committees.
Apply Good Clinical Practice and Human Subjects Protection practices; maintain familiarity with research ethics and safeguards.
Assist with study design safeguards for ethical conduct and protection of vulnerable populations, and develop or assist with safety and security documents.
Explain to participants the distinction between clinical and research activities and the risks and benefits of participation.
Use electronic data capture systems, technologies, and software needed for study operations.
Score tests, enter data, and complete Case Report Forms accurately and according to protocol.
Develop or assist with data-collection documents, instruments, and quality-assurance procedures.
Monitor data capture, collection, and management for potential issues; suggest solutions; investigate incomplete, inaccurate, or missing data and documents.
Run queries, summaries, and reports to monitor data quality; recognize data-quality trends and escalate issues as appropriate.
Use required processes, policies, and systems to ensure data security.
Follow professional guidelines, research ethics, and Dartmouth-Hitchcock and project-specific training requirements.
Travel to investigator meetings or protocol-specific training as needed.
Participate in new-employee mentoring or training under the guidance of a supervisor or senior team member.
Organize and manage clinical trials and research studies; review protocols for feasibility and seek new research opportunities.
Participate in study-site selection activities.
Collaborate with investigators to develop recruitment and screening procedures; design and develop recruitment documentation.
Compose informed consent forms and protocol abstracts, and maintain other study documents and management tools.
Participate in manuscript or abstract development.
Serve as a liaison among principal investigators, regulatory agencies, Dartmouth-Hitchcock stakeholders, and study participants to resolve problems.
Recognize team members' roles and uphold the value of interdisciplinary teamwork.
Perform other duties as required or assigned.