Clinical Research Coordinator II - Orthopedics - Hand Center

General Summary of Position

We are actively recruiting for an experienced Clinical Research Coordinator II to join our Hand Center research team at MedStar Health Research Institute at MedStar Union Memorial Hospital in Baltimore, Maryland.

Implements and coordinates research and administrative procedures for the successful management of clinical trials. Performs diverse administrative duties requiring analysis, sound judgment and a high level of knowledge of study specific protocols. Enters study and / or research participant data into the Clinical Trial Management System (CTMS) as applicable.

Primary Duties and Responsibilities

• Regulatory responsibilities include the oversight and / or responsibility for the Intuitional Review Board (IRB) submissions, and other related regulatory forms (e.g., scientific review), and adhering to the timelines of the study start-up process; developing informed consent documents and other documents as applicable; supporting the safety of clinical research participants; ensuring the appropriate delegation of study related tasks (i.e., Delegation of Authority).
• Explains the informed consent process and the study to the research participant (e.g., purpose, duration, risks / benefits) and obtains all required signatures; ensures the research participant has sufficient time and opportunity to ask the investigator medical questions; documents the informed consent process in the source document and provides the research participant with a copy of the informed consent.
• Develops an effective recruitment plan (e.g., central recruitment core); recruits research participants and discuss study protocol; educates research participants about protocol expectations and meets with research participants for each visit and maintains accessibility to discuss any questions or concerns regarding the study.
• Data entry responsibilities include the completion and maintenance of case report forms and reviews data against the research participant's medical record for completeness and accuracy; addressing all queries, clarifications and outstanding data queries and appropriately communicating with the sponsor and / or Contract Research Organization (CRO); completing and submitting case report forms on as close to a real time basis" as possible.
• Ensures proper collection, processing and shipment of biospecimens and pharmacokinetics as applicable (e.g., centrifuge, freezing, refrigeration) and maintains current Occupational Safety and Health Administration (OSHA) training regarding Bloodborne Pathogens;
• Study conduct responsibilities include research participant interviews and assessments at study visits as required by protocol; assessing and ensuring research participant safety through study participation; maintaining close communication with investigator;
• Attending investigator meetings as appropriate and communicating relevant information to the research team; understanding and proficiently communicating all components of research documents, such as protocol, investigator brochure and research instructions.
• Study close-out responsibilities include return or disposition of unused supplies per sponsors requirement; reconciling test article accountability; document research participants who are lost to follow-up or who have dropped out (e.g., causes, contact efforts); ensuring long term storage of documents; submitting IRB closing report (i.e., termination) after sponsor has closed study site.
• Acts as a liaison with research participants, investigators, sponsors and healthcare professionals; prepares for site qualification, study initiation, monitoring and close-out visits.

Minimum Qualifications

Education

Experience

Knowledge, Skills, and Abilities

This position has a hiring range of $58,656 - $98,384

Salary : $58,656 - $98,384