This sign-on bonus is available to external hires only for full-time 40-hour positions only. Certain conditions do apply.
In order to qualify for a level II position, you must have a Bachelor’s or equivalent years of experience, 2 years of post-college research experience, OR equivalent years of relevant experience. SOCRA or ACRP is preferred.
Requires BLS certification within 30 days of hire. These positions are on site in Lebanon, NH.
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 requires a license to perform.
RESPONSIBILITIES:
Research Operations
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 the supervision of the investigator.
May interview study participants about medical history, medications, adverse events, demographics, and quality of life issues depending on the 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.
QUALIFICATIONS:
Bachelor’s 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 certification is required within 30 days of hire
Dartmouth Hitchcock Medical Center and Clinics are part of the Dartmouth Health system in northern New England. From our beautiful facilities and extraordinary employees to the majestic mountains and lakes of the Upper Valley of New Hampshire, you’ll find a place where you can thrive, both personally and professionally. As the state’s only Academic Medical Center and Level-I Trauma Center, Dartmouth Hitchcock Medical Center provides some of the most sophisticated and technologically advanced tertiary care in the country.
We are also incredibly proud of the awards and recognition that reinforce who we are as an employer. Dartmouth Hitchcock Medical Center was recently named the #1 hospital in New Hampshire by U.S. News & World Report, and we were also recognized by Forbes as America’s Best in State Employer for the state of New Hampshire.
At Dartmouth Health, we believe that the diversity of our patients, people, and community shows a strength we support and celebrate. We are committed to creating a welcoming and inclusive environment for everyone to thrive, honoring all within our organization and the communities we serve. Our belief is simple and actionable: Dartmouth Health is better when we embrace each other with open hearts and minds, confront our biases, and take a stand for equity and inclusion.
How can the lifestyle in New Hampshire and Vermont compliment your career? You can have amazing 4-season living with a career at one of the top health systems in the country. The Dartmouth-Hitchcock health system stretches over New Hampshire and Vermont and offers the quintessential New England experience. With no income or sales tax, this beautiful area combines history, industry and business and has been ranked consistently as one of the best places in the US to live and work. Anchored by the academic Dartmouth-Hitchcock Medical Center in Lebanon, NH, the system includes the NCI-designated Norris Cotton Cancer Center, the Children's Hospital at Dartmouth-Hitchcock; 4 affiliated hospitals and 30 Dartmouth-Hitchcock ambulatory clinics across the region. We are close to the urban centers of Boston, New York and Montreal, but also offer proximity to the seacoast and multiple top-tier ski mountains within a short driving distance. Throughout New Hampshire, the opportunities – both career and personal – truly make our area the ideal place to work and play.Dartmouth-Hitchcock is an equal opportunity employer and all qualified applicants will receive consideration for employment without ...regard to race, color, religion, gender, national origin, disability status, veteran status, or any other characteristic protected by law.