Research Coordinator I - Medical Specialties

Dartmouth Health; Lebanon (NH); Vor Ort; USD 26.000 - 41.000; Vollzeit

Zusammenfassung

Dartmouth Health is seeking a Clinical Research Coordinator I to support study operations under the supervision of the Principal Investigator. This role emphasizes regulatory compliance, data entry in CTMS, and coordination of site activities.

Responsibilities include assisting with regulatory submissions, maintaining essential documents, coordinating site visits, and ensuring data quality in CTMS and CRFs.

Qualifikationen

• Bachelor's degree or equivalent combination of education and experience required.
• Previous research experience preferred.
• BLS certification within 30 days of hire date.
• Human Subject Protection, Responsible Conduct of Research and Good Clinical Practice certificates required within 30 days of hire.

Aufgaben

• Arrange and schedule required appointments.
• Support all study operations with oversight from the investigator or designee.
• Assist with subject management and data entry in CTMS; scan informed consents into EMR.
• Assist with compiling and maintaining essential regulatory documents for IRB submissions and sponsor communications.
• Maintain on-site and off-site storage of study records and tracking of essential documents.
• Assist with local and commercial IRB submissions, modifications, renewals, and closeout procedures.
• Follow ICH GCP guidelines and ensure data integrity and security.
• Complete all required training and adhere to professional guidelines.

Ausbildung

Bachelor's degree or equivalent

Jobbeschreibung

Overview

Clinical Research Coordinator I works closely with other research staff and is involved at a fundamental level to support basic administrative clinical trial tasks. The Clinical Research Coordinator I has no supervisory responsibilities and works under direct supervision of the Principal Investigator or designee. They cannot perform any tasks that by state or local law require a license to perform.

Responsibilities

Research Operations

1. May arrange/schedule required appointments.
2. Learns and supports all of aspects of the study operations (subject management/regulatory) with substantial oversight from the investigator or their designee.
3. Primarily supports subject management, such as subject visit preparation, performs data entry in the Clinical Trial Management System (CTMS), scans informed consents into Electronic Medical Record (EMR) and supports data entry needs of the study.

Regulatory Affairs

1. Assists with compiling and maintaining essential records and documents required by Dartmouth-Hitchcock Medical Center (DHMC) and various sponsor organizations in compliance with applicable standards operating procedures for the execution of clinical trial operations, including timely Institutional Review Board (IRB) submissions meeting sponsor and departmental requirements.
2. Provides support to supervisor and IRB with regard to regulatory and sponsor-related issues.
3. Assists with maintaining accurate and timely sponsor communications regarding status of research studies.
4. Under the direction of the supervisor, assists DMHC investigators with regulatory processes.
5. Maintains basic current understanding of IRB and Dartmouth-Hitchcock Health (D-HH) Institutional processes.
6. Maintains and tracks on-site and off-site storage of required study records and assists with data entry and accurate use of a tracking system for maintaining required essential documents.
7. Assists with local and commercial IRB, including initial submissions, modifications, renewal applications, and study closeout procedures.
8. Assists with scheduling and coordination of site visits, participates in site visits as assigned and tracks and ensures action items noted during site visits are completed and closed.
9. Tracks all required essential regulatory documents according to International Council on Harmonization (ICH) Good Clinical Practice (GCP) guidelines including but not limited to: investigators’ Curriculum Vitae (CVs), medical licenses, Collaborative Institutional Training Initiative (CITI), clinical laboratory certifications, etc.

Ethics & Participant Safety

1. Adheres to the principles for the ethical conduct of research, and safeguards for protection of human subjects especially when conducting research with vulnerable populations.
2. Understands and prioritizes the safety of research participants.

Data and Informatics

1. Utilizes Electronic Data Capture (EDC) systems, technologies and software necessary for study operations.
2. Completes data entry related to test results and/or measures according to protocol, and appropriate to role. Completes paper and electronic Case Report Forms (CRFs and eCRFs) accurately and according to protocol.
3. Assists with investigating incomplete, inaccurate or missing data and or documents to ensure accuracy and completeness of data; follows Standard Operating Procedures (SOPs) for data quality assurance.
4. Appropriately utilizes standard processes, policies and systems to ensure data integrity, attribution, and security.

Leadership and Professionalism

1. Understands and demonstrates the professional guidelines and code of ethics related to the conduct of clinical research.
2. Completes all D-H and project-specific training requirements.

Site and Study Management

1. Assists with administrative tasks associated with clinical research studies (e.g. document and supply management).
2. Maintains lab kits and creates and maintains regulatory and subject binders.
3. May participate in manuscript/abstract development.

Communication and Team Science

1. Communicates appropriately (written and orally) between stakeholders.
2. Assists with communications between principal investigators, regulatory agencies, D-H stakeholders and study participants to resolve problems.
3. Performs other duties as required or assigned.

Qualifications

• Bachelor's degree or the equivalent combination of education and experience required.
• Previous research experience preferred

Required Licensure/Certifications

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

• Area of Interest: Research/Science
• Pay Range: $19.20/Hr. - $29.76/Hr.
• FTE/Hours per pay period: 1.00 - 1.00 - 40 hrs/week
• Shift: Day
• Job ID: 41864

Dartmouth Health offers a total compensation package that includes a comprehensive selection of benefits. Our Core Benefits include medical, dental, vision and life insurance, short and long term disability, paid time off, and retirement plans.

Click here for information on these benefits and more: Benefits | DHMC and Clinics Careers

Dartmouth Health is an Equal Opportunity and Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy-related conditions), sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, veteran or military status, or any other status protected by applicable federal, state, or local law.

Dartmouth Health provides reasonable accommodations to qualified individuals with disabilities and to applicants and employees with sincerely held religious beliefs in accordance with applicable law. Applicants who require an accommodation during the application or interview process may contact [e-mail] for assistance.