Clinical Research Coordinator IIClinical 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:
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 requiredSOCRA/ACRP Certification or eligible for certification preferred
- Required Licensure/CertificationsBLS 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.
