Clinical Research Coordinator I

General Summary of 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.

Primary Duties and 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.

Minimal Qualifications
Education

• High School Diploma or GED required.
• Bachelor's degree oran allied health professional degree preferred

Experience

• 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
• Experience in a healthcare setting preferred

Knowledge Skills and Abilities

• Verbal and written communication skills.
• Basic computer skills preferred