MedStar Health · 8 hours ago
Clinical Research Coordinator I - Cardiology
Clinton, MD
Full-time
Onsite
Entry Level
1+ years expMedStar Health is seeking a Clinical Research Coordinator I to support clinical research studies. The role involves managing IRB submissions, participant screening and enrollment, as well as ensuring compliance with regulatory requirements.
Health CareMedical
Responsibilities
Assists and/or responsible for the Institutional Review Board (IRB) submissions and other related regulatory forms (e.g. radiation safety); coordinates essential regulatory documents and submits timely and accurate regulatory documents to the sponsor as applicable; supports the safety of clinical research participants; ensures the appropriate delegation of study related tasks (i.e. Delegation of Authority)
Participates in the informed consent process of research participants
Pre-screening of potential research participants to determine their initial eligibility and interest in a research study and adhering to important guideline to protect the privacy of the patient; screen recruit and enroll research participants
Maintains study source documents (e.g. surgical reports pathology reports medical history); accurately completes and maintains case report forms; addresses all queries and clarifications; documents written and verbal communication with study contacts (e.g. research participant sponsor laboratory); completes and submits case report forms on a close to a real time basis
Ensures proper collection processing and shipment of biospecimens (e.g. centrifuge freezing refrigeration); maintains current Occupational Safety and Health Administration (OSHA) training regarding Bloodborne Pathogens; maintains International Air and Transportation Association (IATA) training for routine packaging labeling and transporting of biological materials
Receives and maintains test articles form sponsor and inventory test articles; works with research pharmacist as applicable; stores test articles according to Food and Drug Administration (FDA) regulations and sponsor requirement; with oversight administers test article as appropriate; retrieves test articles and calculates research participant compliance as applicable; documents on accountability log and research participant record (e.g. test article received used disposed)
Ensures that non-serious and serious adverse events are properly identified documented and reported per all applicable requirements; presents investigator with relevant information for determination of seriousness causality and intervention; acts of investigator's recommendation for adverse event intervention (e.g. stop test article calls research participant re-test treat); maintains follow-up to determine resolution of adverse event
Understands and complies with rules for billing Medicare Medicaid and third party payors for services drugs devices tests and procedures rendered in the clinical research context; responsible for following the billing matrix/billing plan generated by administration for research participants enrolled in clinical studies; ensures research participant stipend information is submitted
Close-out responsibilities include the return or disposition of unused supplies per sponsor requirement; reconciles test article accountability; documents research participants who are lost to follow-up or who have dropped out (e.g. causes contact efforts)
Coordinates protocol related research procedures study visits and follow-up care; with oversight from the clinical research team educates research participants and family on protocol and study intervention; facilitates site qualification study initiation and monitoring visits; works effectively with multidisciplinary ancillary and inter-professional research teams; possesses a basic understanding of scientific center goals and the importance of serving our customers
Must comply with federal state and sponsor policies; must comply with institutional policies procedures and guidelines; must possess basic understanding of the ethical treatment of research participants aspects of human protection and safety in the conduct of clinical research (21 CFR 50 Protection of Human Subjects 21 CFR 54 Financial Disclosure 21 CFR 56 Institutional Review Boards)
Qualification
Required
High School Diploma or GED required
1-2 years Relevant clinical research experience or equivalent combination of education and experience required
Undergraduate and/or work experiences that demonstrate aptitude for research facilitation required
Verbal and written communication skills
Preferred
Bachelor's degree or an allied health professional degree preferred
Experience in a healthcare setting preferred
Basic computer skills preferred
Company
MedStar Health
MedStar Health is a not-for-profit healthcare organization
10001+ employees
H1B Sponsorship
MedStar 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 (18)
2024 (13)
2023 (14)
2022 (14)
2021 (12)
2020 (14)
Funding
Current Stage
Late StageTotal Funding
$29MKey Investors
American Medical AssociationAgency for Healthcare Research and QualityA. James and Alice B. Clark Foundation
2023-06-21Grant
2022-09-27Grant· $2M
2020-07-03Grant· $27M
Leadership Team
David Mayer
Executive Director MedStar Institute for Quality and Safety Quality and Safety CEO Patient Safety Mo
Recent News
2025-12-17
Maryland Daily Record
2025-12-05
Company data provided by crunchbase