Clinical Research Coordinator I - Cardiology

Medstar Research Institute•Clinton, MD

44d

About The Position

Under moderate supervision of the Manager the Clinical Research Coordinator I is responsible for a variety of activities in support of clinical research studies. The Clinical Research Coordinator I is responsible for the implementation of their assigned portfolio of studies which may include but not limited to IRB applications and related forms data collection forms patient screening and enrollment verification of investigative procedures to accomplish research goals and preparation of reports. Required to enter study and/or research participant data into the Clinical Trial Management System (CTMS) as applicable.

Requirements

High School Diploma or GED required or equivalent required
1-2 years Relevant clinical research experience or equivalent combination of education and experience. required
Undergraduate and/or work experiences that demonstrates aptitude for research facilitation required
Verbal and written communication skills.
Basic computer skills preferred

Nice To Haves

Bachelor's degree preferred or an allied health professional degree preferred
Experience in a healthcare setting preferred

Responsibilities

Contributes to the achievement of established department goals and objectives and adheres to department policies procedures quality standards and safety standards; complies with governmental and accreditation regulations.
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).
Must possess basic understanding of Good Clinical Practices (GCPs) provided by the International Conference of Harmonization (ICH).
Required MedStar Health Research Institute trainings include but not limited to Collaborative Intuitional Training Initiative (CITI) Conflict of Interest (COI) and annual MedStar Health mandatories.
Participates in multidisciplinary quality and service improvement teams as appropriate. Participates in meetings serves on committees and represents the department and hospital/facility in community outreach efforts as appropriate.