RN Clinical Research Coordinator - RN Required

• Ensures ongoing research informed consent, addresses participant questions throughout study participation, and supports their goal for participating or terminating study participation.
• Coordinates research activities to minimize participant risk and ensure participant safety.
• Distributes study articles (drugs, devices), administers study drugs, and maintains study article accountability documentation.
• Provides patient education and medical information to study patients to ensure understanding of proper medication dosage, administration, and disease treatment.
• Performs medical tests, including but not limited to vital signs, sample collection, and electrocardiograms.
• Collects, prepares, processes, and ships biological samples per study protocols and International Air Transport Association (IATA) requirements.
• Provides care coordination and continuity, integrating research and clinical activities to meet the clinical needs of research participants, coordinates and completes research protocol activities, and communicates with referring providers when necessary.
• Ensures appropriate credentialing and training of the Memorial Healthcare staff regarding research and protocol requirements.
• Ensures scientific data integrity and maintains participant privacy, confidentiality, and safety of patients enrolled in clinical trials.
• Develops source documentation forms and tools per study protocol requirements.
• Documents all study-related procedures/events via electronic data capture systems, case report forms, etc.
• Communicates effectively with research participants and their families, the research team, principal investigators, external study sponsors, primary care providers (e.g., clinical nurses, physicians, etc.), ancillary staff, and the IRB to ensure protocol adherence, participant safety, and Regulatory compliance.
• Participates in study site activation activities, including regulatory documentation training of the research team and impacted departments.
• Participates in clinical study planning for investigator-initiated Initiated Trials sponsored research agreements.
• Prepares and conducts training activities for assigned trials. The number of trials depends on the phase, number of enrolled subjects, and study complexity.
• Assists with internal and external site audits.
• Supports regulatory efforts in maintaining regulatory documents following Memorial Healthcare Standards of Practice and applicable regulations.
• Assists in maintaining clinicaltrials.gov information for investigator-initiated Initiated Trials and Sponsored Research Agreements.
• Promotes research revenue cycle best practices by communicating protocol coverage as outlined in the study’s Medicare Coverage Analysis (modifier codes, secondary diagnosis, etc.).
• Maintains accurate documentation of study stipend and reimbursement per study protocol, informed consent, and budget.
• Acts as a liaison between site, investigators, principal investigator, Memorial Healthcare, IRBs, and study sponsors.
• Creates study-related reports as requested.
• Participates in meetings and provides information regarding applicable clinical trials.
• Participates in continuing education activities related to research to improve knowledge for job performance.
• Ensures compliance with research protocols by providing ongoing quality control audits, including ongoing investigational drug accountability.
• Participates with the PI and study team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance.
• Maintains IATA, Good Clinical Practice, and other certifications as required.
• Occasional travel to satellite sites and to attend sponsor study training meetings as required
• Performs other duties as assigned.

• Clinical Research Certification CCRC/CCRP is preferred but not required.

• Minimum of 3-5 years experience with research-related activities with clinical practice, ICH guidelines, FDA and OHRP regulations, IND and SAE reporting, and protection of human research participant standards, regulations, and laws preferred.
• Current phlebotomy and ECG skills preferred
• MS Word, Excel, Outlook, and EMR experience required
• BLS required

• Vision: Requires the ability to perceive the nature of objects by the eye. Near acuity: Clarity of vision at 20 inches or less. Midrange Acuity: Clarity of vision at distances of more than 20 inches and less than 20 feet.
• Motor Coordination: While performing the duties of the job, it is required to regularly perform functions that include using hand and finger movement, handle or feel objects, be able to use tools or equipment that requires reaching with hands and arms. Must be able to travel independently throughout hospital; access patients/families including areas confined by space and/or equipment.
• Speaking/Hearing: Ability to give and receive information through speaking and listening skills.

• Use of Microsoft Office Products
• Computer and basic office equipment proficiency required.

• Detailed oriented with strong written and verbal communication skills.
• Able to problem solve. Identifies and resolves problems in a timely manner. Gathers and analyzes information skillfully.
• Analytical, prioritization and planning of work activities.
• Adapts for changing conditions.
• Ability to manage multiple priorities.

• Adapts to changes in the work environment.

Memorial Healthcare