Dartmouth Health

Academic health system and medical education

Clinical Research Coordinator 2 - Cancer Center

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeLebanon, NH, USANo salary listedIn-person

About the Job

Requirements

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

Responsibilities

Arrange and schedule required tests and other appointments as needed.
Support study operations, including subject management and regulatory work, under investigator oversight.
Support subject management through Clinical Trial Management System data entry, scanning informed consents into the electronic medical record, and other study data-entry needs.
Carry out study visit tasks, such as administering Quality of Life questionnaires, under investigator supervision.
Interview study participants about medical history, medications, adverse events, demographics, and quality-of-life issues as appropriate to complexity, with Principal Investigator review and source data collected from medical records.
Communicate with participants throughout 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.
Manage study tasks involving Institutional Review Boards, study sponsors, and Dartmouth-Hitchcock Medical Center regulatory committees.
Apply Good Clinical Practice and Human Subjects Protection practices and safeguards for ethical research.
Assist in designing studies with safeguards for ethical conduct and vulnerable populations, and develop safety and security documents.
Explain to research participants the differences between clinical and research activities and the risks and benefits of participation.
Use Electronic Data Capture systems, technologies, and software for study operations.
Score tests, enter data, and complete Case Report Forms and electronic Case Report Forms accurately and according to protocol.
Develop or assist with data-collection documents, instruments, and data-quality-assurance procedures.
Monitor data capture, collection, and management for potential issues; investigate incomplete, inaccurate, or missing data and documents, and suggest solutions to ensure data accuracy and completeness.
Run queries, summaries, and reports to monitor data quality; recognize data-quality trends and escalate as appropriate.
Use required processes, policies, and systems to ensure data security.
Follow professional guidelines and codes of ethics for clinical research, Dartmouth-Hitchcock, and project-specific training.
Travel to investigator meetings or protocol-specific training as needed.
Participate in new-employee mentoring or training under 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 and collaborate with investigators to develop recruitment and screening procedures.
Design and develop recruitment documentation; compose informed consent forms and protocol abstracts; maintain study documents and management tools.
Participate in manuscript or abstract development as needed.
Serve as a liaison among principal investigators, regulatory agencies, Dartmouth-Hitchcock stakeholders, and study participants to resolve problems.
Recognize team members' roles and uphold interdisciplinary collaboration in clinical studies.
Perform other duties as required or assigned.

Desired Qualifications

SOCRA or ACRP certification, or eligibility for certification.

Overview

Clinical Research Coordinator II performs a full range of clinical research duties at a skilled level and has a working knowledge of the clinical research process and the regulations that govern it. The expectation is to perform progressively more complex and comprehensive clinical research duties with an increasing level of independence, working closely with the Principal Investigator (PI). The Clinical Research Coordinator II works under the supervision of and at the direction of the PI or their designee. They cannot perform any tasks that state or local law require a license to perform.

Responsibilities

Research Operations – Occasionally requiring tasks outside of defined operating hours

May arrange and/or schedule required tests and other appointments.

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

Primarily supports subject management, such as data entry in the Clinical Trial Management System(CTMS), scanning informed consents into EMR, and supporting data entry needs of the study.

May carry out study visit tasks such as administering Quality of Life (QoL) questionnaires under supervision of investigator.

May interview study participants about medical history, medications, adverse events, demographics, and quality of life issues depending on complexity with review by PI with collection of source data directly informed by medical records.

May communicate with participants throughout the course of the study.

May provide education and support to study participants and their families.

Prepares and submits regulatory documents to study sponsors and applicable regulatory agencies.

Maintains study and regulatory documentation.

May manage study tasks primarily related to working with Institutional Review Boards (IRBs) and study sponsors as well as Dartmouth-Hitchcock Medical Center (DHMC) regulatory committees.

Ethics & Participant Safety

Applies and implements Good Clinical Practice (GCP)/Human Subjects Protection (HSP) practices.

Maintains familiarity with the ethical conduct of research and safeguards needed when conducting research.

May assist in the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations.

May develop or assist with the development of documents related to safety and security.

May communicate with research participants regarding the difference between clinical activities and research activities, and the risks and benefits of study participation.

Data and Informatics

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

Scores tests, enter data, and completes Case Report Forms (CRFs, eCRFs) accurately and according to protocol.

Develops or assists with the development of data collection documents and instruments and procedures for data quality assurance.

Monitors for and identifies potential issues related to data capture, collection or management and suggests solutions. Investigates incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data.

Adheres to processes and runs queries, summaries and reports to monitor the quality of data.

May be responsible for recognizing trends related to data quality and escalating as appropriate.

Uses required processes, policies and systems to ensure data security.

Leadership and Professionalism

Understands and employs the professional guidelines and code of ethics related to the conduct of clinical research and Dartmouth-Hitchcock (D-H) and project specific training requirements.

May travel to investigator meetings or protocol specific training.

May participate in new employee mentoring/training under the guidance of a supervisor or senior team member.

Site and Study Management

Organizes and manages clinical trials and research studies.

Conducts protocol reviews to assess the feasibility of potential studies. Seeks out new research opportunities.

Participates in study site selection activities.

Collaborates with study investigators to develop recruitment and screening procedures.

Designs and develops recruitment documentation.

Composes informed consent forms and protocol abstracts.

Maintains other study documents and study management tools.

May participate in manuscript/abstract development.

Communication and Team Science

Serves as a liaison between principal investigators, regulatory agencies, D-H stakeholders and study participants to resolve problems.

Identifies and recognizes the respective roles of team members.

Understands and upholds the importance of an interdisciplinary team and the value each member can bring to clinical studies.

Performs other duties as required or assigned.

Qualifications

Bachelors and 2 years of relevant research experience OR equivalent years of experience
Ability to travel as required
SOCRA/ACRP Certification or eligible for certification preferred

Required Licensure/Certifications

BLS required within 30 days of hire date
Human Subject Protection, Responsible Conduct of Research and Good Clinical Practice certificates required within 30 days of hire.

About the Company

Dartmouth Health

Academic health system and medical education

Dartmouth Health runs New Hampshire’s largest private employer and a regional academic health system serving northern New England, with DHMC and a wide network of hospitals and clinics. It provides care through more than 2,000 providers across nearly every specialty, including the Dartmouth Cancer Center and Dartmouth Health Children’s. It blends clinical care with education and research by training about 400 residents and fellows each year with Dartmouth and the Geisel School of Medicine, and by conducting clinical trials with Geisel and the White River Junction VA Medical Center. Its goal is to deliver exceptional, personal care while advancing medicine and meeting the health needs of the communities it serves.

Company size: 201-500
Company stage: Not listed
Total funding: Not listed
Headquarters: Lebanon, NH
Founded: Not listed

Recently Posted Jobs

Explore more opportunities at Dartmouth Health

See more jobs