Clinical Research Coordinator

Job Summary Location: Methodist Physicians Clinic - Westroads Office Park III 1120 N. 103rd Plaza - Omaha, NE Work Schedule: Monday through Friday, hours between 8am - 5pm This position is on site only and not able to be offered as remote Responsibilities Trial Management- Clinical or Device Verifies investigator/site feasibility, facilitates site budget/contract approval process, and develop timelines for conducting and completing the trial, as well as manage financial agreements. Attends Investigator Meetings as required. Prepare and submit initial study submission to IRB/IEC and/or sponsor for review and approval. Select the investigational staff and assign roles and responsibilities, ensuring appropriate training of staff. Maintain trial master file (e.g., regulatory binder), Identify minimum regulatory document requirements for site trial master file (e.g., country-specific regulatory documents), while ensuring IRB/IEC review/approval of study and study documents. Develop and follow a recruitment strategy and study management plan, maintain screening/enrollment log and ensure trial subject retention. Select and manage local vendors (e.g., laboratory, x-ray, MRI), and maintain current vendor credentials (e.g., lab certification/licensure and normal ranges) as applicable. Prepare study documentation (e.g., schedule of events, description of procedures) as well as modifying per protocol amendments require. Search clinical databases for potential participants, and schedule participants for protocol specific procedures, including multi-department visits as indicated in protocol. Conduct informed consent, working with the participant's the trial Investigator and/or Primary Care Physicians to ensure the participant understands study design. Collect, record, and report accurate and verifiable data, conducts participant visits according to requirements, documenting protocol deviations/violations and implementing corrective actions plans as applicable. Enter and transmit data, as well as review and resolve CRF queries from the study monitor/data management. Communicate laboratory/diagnostic results with Principal Investigator and Sponsor/CRO ensuring timely review of study data (e.g., laboratory results, x-rays). Manage study supplies (e.g., lab kits, case report forms), equipment (e.g., calibration and preventive maintenance), and study record retention and availability. Coordinate study monitoring visits, including site initiation, interim and close-outs. Prepare study documents and study summary and/or close-out letter for IRB/IEC. Interrogate implantable cardiac devices (i.e. pacemakers, defibrillators). Analyze implantable cardiac devices, perform diagnostic tests, and make appropriate device programing changes. Trial Oversight Ensure adequate site management, while being compliant with electronic data requirements (e.g., electronic health records, eCRF). Ensure access to source data by authorized parties, in accordance with ICH-GCP, and protect confidentiality by limiting unauthorized access. Respond to or facilitate response to audit/inspection findings. Ensure proper adverse event reporting by the investigator. Escalate problems to appropriate in-house management. Investigate and/or report potential fraud and misconduct. Ensure follow-up medical care for study subjects is documented, as applicable. Ensure staff, facility, and equipment availability throughout the study. Ensure compliance with study requirements and regulations. Safety Assess participant safety during trial participation, by reviewing participant's medical records, as well as self-reported adverse events. Collaborates with physicians and nurses to coordinate a patient's plan of care to prevent duplication of patient services and to ensure continuity of care. Minimize potential risks to subject safety, oversee safety risks (e.g., clinical holds, product recalls), handle medical monitor oversight. Report required adverse events to Sponsor/CRO, regulatory authorities, and/or IRB/IEC, ensure proper documentation of adverse events, coding correctly (e.g., serious, severe, moderate, mild, expected, unexpected, and causality). Ensure reasons for subject discontinuation are documented (i.e., causes, contact efforts). Manage and motivate the investigational staff and other disciplines involved, and take measures to minimize any potential risks. Inform the sponsor and IRB/IEC of any changes to the protocol or safety concerns and submit progress reports to the IRB/IEC per requirements. Review common laboratory values and alerts, review for potential subject safety issues (e.g., toxicity, significant lab values). Implement Investigator's plan of action for management of adverse event (e.g., stop investigational product; call, retest, treat subject). Maintain follow-up to determine resolution of adverse event. Document follow-up medical care for study subjects, as applicable. Conduct safety monitoring/reporting activities. Initiate un-blinding procedures. Protocol Evaluate and review protocol for feasibility, review protocol during Investigator's meeting. Possess knowledge of protocol development, submission, and approval process, including protocol amendment submission and approval procedures. Understand clinical trial phases, study design characteristics, (e.g., double-blind, crossover, randomized), and study objective. Verify the eligibility of potential trial subjects, reviewing inclusion/exclusion as defined by the protocol. Execute study per protocol, following description of procedures (e.g., vitals, blood collection, EKG). Ensure proper collection, processing, and shipment of biological specimens (e.g., centrifuge, preparation of slides, freezing, and refrigeration). Investigational Product Management Ensure adequacy of investigational product and other supplies at site. Ensure randomization and emergency codes of investigational product have been maintained. Ensure proper storage, dispensing, handling, and disposition of investigational product and other supplies. Reconcile, maintain, prepare, dispense, and retrieve investigational product. Physical Requirements Weight Demands: Medium work - Exerting up to 50 pounds of force Physical Activity Not necessary for the position (0%): Climbing Crawling Kneeling Sitting Occasionally Performed (1%-33%): Balancing Carrying Crouching Distinguish colors Keyboarding/typing Lifting Pulling/Pushing Repetitive Motions Stooping/bending Twisting Frequently Performed (34%-66%): Balancing Carrying Crouching Distinguish colors Keyboarding/typing Lifting Pulling/Pushing Repetitive Motions Stooping/bending Twisting Constantly Performed (67%-100%): Grasping Hearing Reaching Seeing/Visual Speaking/talking Standing Walking Job Hazards Not Related: Electrical Shock/Static Radiation Non-Ionizing (Ultraviolet, visible light, infrared and microwaves that causes injuries to tissue or thermal or photochemical means) Rare (1-33%), Radiation Alpha, Beta and Gamma (particles such as X‑ray, Cat Scan, Gamma Knife, etc) Occasionally (34%-66%): Physical hazards (noise, temperature, lighting, wet floors, outdoors, sharps) (more than ordinary office environment) Equipment/Machinery/Tools Explosives (pressurized gas) Frequent (67%-100%): Chemical agents (Toxic, Corrosive, Flammable, Latex) Biological agents (primary air born and blood born viruses) (Jobs with Patient contact) (BBF) Nebraska Methodist Health System is an affirmative Action/Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, age, national origin, disability, veteran status, sexual orientation, gender identity, or any other classification protected by Federal, state or local law. #J-18808-Ljbffr Nebraska Methodist Health System