Clinical Research Coordinator I jobs in United States
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Novant Health · 21 hours ago

Clinical Research Coordinator I

Novant Health is a healthcare organization dedicated to providing remarkable care with compassion. The Clinical Research Coordinator I will facilitate and coordinate daily clinical trial activities, ensuring compliance with regulatory requirements and assisting in patient enrollment for clinical trials.

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H1B Sponsor Likelynote

Responsibilities

Sets up and performs routine clinical trial related activities
Collects, enters and summarizes clinical trial data
Monitors patients, their results, detects and reports all events per protocol, applicable policies and applicable regulations
Complies with all regulatory requirements related to the conduct of research (FDA, GCP, IRB, ICH)
Assures regulatory submissions for all protocols, adverse events, revisions, renewals, and terminations
Communicates protocol information (through meetings, presentations, etc.) to physicians and staff
Read and understand clinical research protocols, informed consent documents and related materials
Assists in verifying patient history and medical information to assure appropriate enrollment in clinical trials
Confers with prospective study subjects to obtain informed consent as delegated by principal investigator
Schedules and attends patient visits
Perform protocol driven procedures as required and per licensure
Troubleshoot enrollment and study conduct issues
Maintains clinical and professional competency standards
Generates study specific source documents (paper and/or electronic) for use in clinical trial data collection
Collects blood samples, cultures, tissues and other samples for processing, shipping and or analysis
Collects and process information from patient charts, medical records, interviews and appropriate forms
Assesses and reports adverse events in a timely manner
Maintains protocol defined timelines and department guidelines
Completes study specific case report forms, electronic data capture systems and assures appropriate communication with study sponsors
Arranges and attends monitoring visits
Works with Sr. team members to prepare for and attend sponsor and/or FDA audits
Develop knowledge to understand protocol Screens incoming research proposals for feasibility
With leader or senior team member guidance, Coordinates scheduling of pre-site, initiation, monitoring and closeout visits
Assures drug and device accountability is up to date and available at all times

Qualification

Clinical Research ExperienceClinical Practice (GCP)Regulatory ComplianceData ManagementAnalytical SkillsCommunication SkillsInterpersonal SkillsAttention to DetailProblem SolvingTime Management

Required

High School Diploma or GED, required
Requires demonstrated knowledge of complex clinical research concepts gained through education and experience
Works with a high degree of independence, using discretion and independent judgement in the executions of tasks
Human relations and interpersonal skills necessary for interacting with patients and staff
Attention to detail and accuracy necessary
Ability and willingness to work irregular hours as necessitated by research protocols
Excellent verbal and written communication skills
Excellent telephone diplomacy
Working knowledge of Information Systems and database management
Excellent analytical and time management skills
Self-motivated and able to work independently as well as a team
Ability to prioritize and problem solving skills, with demonstrated competency in applying clinical knowledge to patient management
Able to meet multiple deadlines for concurrent projects
Knowledge and assessment skills to provide age appropriate care and protocol requirements

Preferred

4 Year / Bachelors Degree, preferred
Two years experience in clinical research and/or relevant clinical field, preferred
Two years in a healthcare setting or clinical research (CRA, Regulatory, clinic, CRO, pharma/biotech/device company, or other related experience), preferred
Good Clinical Practice (GCP), Human Subjects Training, and International Air Transportation Association (IATA) certification for shipping hazardous and biological substances
Certification in research

Company

Novant Health

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Novant Health is a four-state integrated network of physician clinics, outpatient centers and hospitals.

H1B Sponsorship

Novant Health has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (13)
2023 (13)
2022 (10)
2021 (17)
2020 (7)

Funding

Current Stage
Late Stage

Leadership Team

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Betsy Walsh
Senior Vice President Joint Partnerships
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Andrea M. Areskog
Vice President, Corporate Strategy & Development
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Company data provided by crunchbase