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Dartmouth Health · 12 hours ago

Research Coordinator II - OB-GYN

Lebanon, NH

Full-time

Onsite

Entry, Mid Level

2+ years exp

Dartmouth Health is a healthcare organization seeking a Clinical Research Coordinator II to perform a full range of clinical research duties. This role involves working closely with the Principal Investigator to manage clinical trials, support subject management, and ensure compliance with regulatory standards.

Health CareHospitalMedical

Responsibilities

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

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

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

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

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

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

Qualification

Clinical ResearchClinical Practice (GCP)Electronic Data Capture (EDC)Regulatory DocumentationData Quality AssuranceSOCRA/ACRP CertificationBLS CertificationHuman Subjects Protection (HSP)Communication SkillsTeam Collaboration