Clinical Research

• In collaboration with other members of the clinical research site team, works to support source document requirements for assigned studies.
• Creation of source documents that will follow GCP Guidelines and 21 CFR Part 11 Compliance in addition to internal SOPs.
• Create templates, worksheets, supplemental source for visits based on detailed review of protocol-defined exams, tests, evaluations, and assessments.
• Initial creation of source documents will use all available protocol specific documents (i.e., current IRB approved protocol, blank or annotated CRF, Sponsor provided source templates/worksheets, or reference manuals) to create a source document that is accurate and complete and to ensure that the source document is equipped to record all the required data for the visit.
• Creating, maintaining, updating, control, and release source documents, including paper and electronic source documents in line with the study protocol, and relevant sponsor guiding documents.
• Reviewing draft source and ensuring it is accurate and complete and to ensure that the source document is equipped to record all the required data for the trial.
• Coordinating initial source review and update process.
• Filing, maintaining, distributing, organizing, and archiving source documents for each clinical trial.
• Updating current source documents according to new clinical study protocol amendments.
• Activating studies and visits at the appropriate time.
• Supporting Quality Control (QC) of source documents before it goes to the users.
• Attending all relevant meetings to stay up to date with upcoming studies, progress on current studies, and studies closing out.
• Maintaining a single tracker for the department to track source document design activities and the status of the activities.
• Maintaining version control of all source documents.
• Managing daily communication with site staff and other internal departments.
• Remaining up to date with all assigned Clinical Study Protocol for study.
• Developing and maintaining excellent working relationships with internal and external clients to understand and meet their needs in line with company policies and procedures.
• Maintaining a positive, results-oriented work environment, building partnerships within the team and across the organization at large, and modeling teamwork.
• Participating in continuing education activities to maintain current knowledge of source document design and relevant software.
• Performing all other duties that may be requested or assigned.

Clinical Research Source Development Coordinator

• Ensure compliance with each study’s protocol by providing thorough review and documentation at each subject study visit.
• Participate in recruitment and selection of study participants by interviewing and documenting medical history to determine compliance with eligibility requirements.
• Perform medical tests, collect labs, and administer investigational medications and perform patient assessments during clinic visits to determine presence of side effects; notify Principal Investigator of findings/issues.
• Provide patient education and medical information to study patients to ensure understanding of proper medication dosage, administration, and disease treatment.
• Document medical data in patient chart to capture protocol requirements.
• Provide accurate and timely data collection, documentation, entry, and appropriate reporting to sponsors and institutions.
• Support regulatory components and site research compliance for study feasibility, study start-up, ongoing study monitoring, and site close out.
• Provide training and mentorship to clinical research team on clinical trial assessments, best practices for clinical research visits, and ALOCA+ data maintenance.
• Serve as liaison between PI, sponsoring agent, regulatory groups, patient, family members, referring MD's/community MD's, pharmacist, statistician, and other members of the research team.

Clinical Research Nurse – Pediatrics

• Drive the execution of Lilly clinical trials through exceptional investigator engagement and site performance management
• Ensure Lilly’s portfolio is prioritized at high-performing sites and that trials are delivered with quality, speed, and insight
• Combine deep therapeutic and scientific knowledge with strategic agility to influence investigators, elevate protocol understanding, and co-develop tailored enrollment strategies
• Serve as trusted partners to investigators, building strong relationships that improve return on enrollment
• Partner closely with internal Lilly teams to ensure that insights from the field shape development strategies
• Lead site-level strategy and risk planning to ensure predictable enrollment and data delivery

Associate Director, Clinical Research Lead – East Coast/Midwest

• Conduct clinical studies according to FDA/GCP and ICH regulations and guidelines.
• Provide medical care to patients, always ensuring patient safety comes first.
• Schedule subject visits within protocol windows, ensuring scheduling capacity is maximized.
• Perform all defined study activities (i.e., informed consent, screening, and protocol procedures which include but are not limited to vital signs, pregnancy tests, height, weight, ECG's, etc.).
• Record all patient information and results from tests as per protocol on required forms.
• Where required, may complete IP accountability logs and associated information.
• Reports suspected non-compliance with relevant site staff.
• Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.
• Promotes the company and builds a positive relationship with patients to ensure retention.
• Attend site initiation meetings and all other relevant meetings to receive training on protocol.
• May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results.
• Logs/complete information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe.
• Gather and maintain source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.
• Adhere to company COP/SCOP.
• May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility.

Traveling Clinical Research Coordinator II

• Coordinating and conducting clinical trial procedures according to protocol requirements
• Performing technical and clinical requirements of study protocols, i.e., venipuncture, specimen processing, vital signs, electrocardiograms, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, injections (IM or SQ) or any procedure necessary for the protocol as ordered by the investigator
• Collecting and documenting patient data accurately and efficiently
• Assisting in patient recruitment, screening, and enrollment processes
• Providing nursing care and support to trial participants
• Collaborating with interdisciplinary teams to ensure trial compliance and quality data collection

Clinical Research Coordinator, Nurse

• Serve as a primary point of contact for study participants during on-site visits, providing a welcoming and professional experience.
• Guide participants through study visit procedures, answering questions and ensuring they feel informed and comfortable throughout the process.
• Assist in the informed consent process, ensuring participants understand study expectations, risks, and benefits prior to enrollment.
• Monitor and document participant well-being during visits, escalating any safety concerns to the supervising Coordinator or Investigator promptly.
• Schedule and confirm participant appointments, sending reminders and managing visit logistics to support timely enrollment and retention.
• Perform and document vital signs, including blood pressure, heart rate, temperature, respiratory rate, and weight.
• Conduct electrocardiograms (EKGs) per protocol, ensuring proper lead placement and tracing quality.
• Perform phlebotomy (blood draws) in accordance with study protocols and applicable safety standards.
• Administer and document other protocol-specified assessments as trained and permitted by scope of practice.
• Collect, process, label, and store biological samples (blood, urine, etc.) per study protocol and applicable regulatory requirements.
• Ensure proper cold-chain handling and timely shipment of samples to central labs or sponsors.
• Maintain specimen logs and chain-of-custody documentation accurately.
• Ensure proper disposal of biohazardous materials in compliance with institutional and regulatory standards.
• Accurately enter study data into the clinical trial management system (CTMS) and/or electronic data capture (EDC) systems in a timely manner.
• Complete and maintain source documentation for all participant visits, assessments, and clinical activities.
• Perform basic quality control checks on data entry to ensure accuracy and completeness.
• Flag discrepancies or missing data to the supervising Coordinator for resolution.
• Assist in preparing exam rooms and ensuring all equipment and supplies are ready prior to study visits.
• Support the Coordinator with site initiation, monitoring visits, and closeout activities as directed.
• Maintain adequate inventory of study supplies and assist with the receipt and storage of study materials.
• Support study staff training on visit procedures as needed.

Clinical Research Assistant

• Ability to phone screen patients or caregivers in caring and empathetic manner.
• Document patient information correctly in the computer database.
• Schedule/reschedule patient screen and prescreen appointments.
• Manage incoming calls from patients interested in taking part in research studies.
• Evaluate eligibility of potential subjects through methods such as screening interviews, reviews of medical records, or discussions with site clinic staff.
• Learn and maintain knowledge regarding clinical research studies including inclusion and exclusion criteria for different studies.
• Record contact status of patients and document information in the database.
• Review, call and update sponsor patient portals as needed.
• Perform all other duties that may be requested or assigned.

Clinical Research Patient Recruiter

• 100% FTE, Monday through Friday, 8 hour shift between 7:00am- 4:00pm; no weekends or holidays
• Hybrid position, in person work location will be UW Health N. Bell School Rd. Clinic 3535 Bell School Rd.

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