Clin/Tran Research Coord II

Responsibilities

Prepare, submit, and manage IRB applications (new studies, amendments, continuing reviews, and adverse event reports) in compliance with institutional policies and federal regulations

Conduct and support study procedures, including participant screening, recruitment, scheduling, informed consent, interviews, assessments, specimen collection, and assisting with EEG/MRI and other protocol-required activities

Accurately collect, document, and enter study data from source documents into paper or electronic case report forms, ensuring completeness, accuracy, and timeliness

Prepare, maintain, and organize regulatory and essential study documents to ensure ongoing compliance with Good Clinical Practice (GCP)

Monitor participant safety by identifying, documenting, and reporting adverse events in accordance with protocol, IRB, FDA, sponsor, and institutional requirements

Coordinate packaging and shipment of biological specimens in compliance with sponsor, laboratory, and shipping regulations, maintaining required documentation

Participate in site visits, audits, and monitoring activities by sponsors and regulatory authorities, addressing queries and resolving findings in a timely manner

Collaborate professionally with investigators, participants, sponsors, and multidisciplinary teams, serving as an advocate for human subject protections

Assist with study operations, including equipment and supply procurement, budget development and tracking, invoicing, and ensuring clinical trial billing compliance

Engage in ongoing professional development through required training, certifications, research councils, and continuous education to maintain and advance clinical research expertise

Benefits

A comprehensive benefits package which may include health, disability, retirement and/or wellness offerings to enhance your well-being and professional growth.

Glassdoor

3.8

Vanderbilt University Medical Center is a nonprofit institution specializing in patient care, research, and nobility in medical education.

Nashville, Tennessee, USA

https://www.vumc.org/main/home

Distribution of Different Job Fields Receiving Sponsorship

53

Represents job field similar to this job

Engineering and Development

Education and Training

Customer Service and Support

Management and Executive

Accounting and Finance

Arts and Entertainment

Trends of Total Sponsorships

*2026

(64)

2025

(89)

2024

(72)

2023

(71)

2022

(113)

2021

(96)

2020

(70)

Qualifications

Excellent written and verbal communication skills

Strong attention to detail and organizational skills

Initiative and sound judgment in a clinical research setting

Adaptability and comfort managing competing priorities

A mindset of continuous improvement and process optimization

Bachelor's degree (or equivalent experience)

1 year of relevant experience

Prior to advancing to a Clinical/Translational Research Coordinator II, must have completed a Research 101 course such as RSS Boot camp

applicant/new hire must complete a Research 101 course within six (6) months of hire

Knowledge and understanding of policies, procedures, and regulations governing human subject's research and incorporates them in securing approval for and the conduct of research

Knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH , and HIPAA regulations

Knowledge and understanding of the implementation, coordination, management and reporting of clinical/translational research operations

Relevant Work Experience

1 year

Bachelor's

Applicant/new hire must complete a Research 101 course within six (6) months of hire

Required skills

Human Subjects Research Regulations, Clinical Practice (GCP), ICH Guidelines, HIPAA Regulations, FDA Regulations, OHRP Guidelines, Clinical/Translational Research Operations

Preferred skills

Written and Verbal Communication

Experience

1+ years