Health Services Research Coordinator
Overview
Join a highly collaborative team conducting impactful research on cancer care delivery, palliative care, and patient-reported outcomes (PRO) symptom monitoring. The Research Coordinator will play a key role in running the PRO-CONNECT trial. The trial is testing a novel patient-reported outcome (PRO)-directed referral system to palliative care among patients with advanced cancer at the Dartmouth Cancer Center. The goal of the research study is to understand how to screen patients for unmet care needs during treatment and connect them to supportive services to improve outcomes for patients. This full-time, on-site position offers hands-on experience working directly with patients with advanced cancer and their families. Ideal for those considering medical or graduate school, this role includes opportunities for mentorship and potential publication.
Examples of Work Performed
Screen, recruit, consent, enroll, randomize and collect data on study participants following the research study protocol. Coordinate the clinical trial under the supervision of the PI, including the scheduling of potential participants, tracking patient participation and drop out, assisting with IRB submissions, and entering and verifying study data. The research will involve collection of patient-reported data, and the researcher must be comfortable with speaking with patients, including in-person, by phone or virtual video visit to collect data. Experience and/or degree of comfort with patients with advanced cancer is necessary.
The researcher will coordinate logistical support for ongoing research project(s) or major sub-component(s) thereof. This may include but is not limited to literature searches and creation of reference libraries with reference management software, developing presentations of data with Word and/or PowerPoint, and coordinating and following up on tasks from research team meetings. This individual will carry out established project objectives and directives. This work often consists of handling varied technical and/or administrative tasks.
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.
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