Clinical Research

• Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
• Oversees site interactions post activation through site closeout.
• This may include patient recruitment, investigator payments or other related activities.
• May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).
• Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/CeMs) is aware of the contractual obligations and parameters.
• Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
• Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope.
• Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
• Participates and presents in key meetings such as Kick Off Meeting.
• Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members.
• This may include accompanying CRA team members to sites for observation or conflict resolution.
• Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines.
• Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities.
• Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan.
• Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed.
• Ensures access and audit trail reviews are conducted as required.
• Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study.
• Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality.
• Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools.
• Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan.
• Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan.
• Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans.
• Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity.
• Document requested revisions and approvals in CTMS.
• Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines.
• Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables.
• Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements.
• Provides solutions for obstacles in protocol execution and site management.
• Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations
• This may include data management, study start up, patient recruitment, medical monitoring, pharmacovigilance and Quality Assurance (QA).
• Supports Inspection Readiness for clinical trial management scope.
• Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks.
• Develop and support execution of corrective action plans at site and study level.
• Supports and completes activities to achieve data cut and lock deadlines.
• Provides feedback to line managers on staff performance including strengths as well as areas for development.
• May be assigned to larger, more complex trials or may coordinate clinical activities for a team of CTMs across a portfolio of projects
• May coach and mentor CTMs regarding functional clinical delivery, evaluation of project risks, and action implementation.

Clinical Trial Manager

• In collaboration with other members of the clinical research site team works to ensure the execution of assigned studies.
• Responsibilities may include but are not limited to:
• - Screening of patients for study enrollment;
• - Patient consents;
• - Patient follow-up visits;
• - Documenting in source clinic charts;
• - Entering data in EDC and answering queries;
• - Obtaining vital signs and ECGs;
• - May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up;
• - Requesting and tracking medical record requests;
• - Updating and maintaining logs, chart filings;
• - Maintaining & ordering study specific supplies;
• - Scheduling subjects for study visits and conducts appointment reminders;
• - Building/updating source as needed;
• - Conducting monitoring visits and resolves issues as needed in a timely manner;
• - Ensuring study related reports and patient results are reviewed by investigator in a timely manner;
• - Filing SAE/Deviation reports to Sponsor and IRB as needed;
• - Documenting and reporting adverse events;
• - Reporting non-compliance to appropriate staff in a timely manner;
• - Maintaining positive and effective communication with clients and team members;
• - Always practicing ALCOAC principles with all documentation;
• - Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc.;
• - Prepare and attend site initiation visits (SIV’s) and Investigator Meetings (IMs), as needed;
• - Handles all IRB functions for assigned studies independently, and/or with assigned regulatory team member, as needed;
• - Assist with training of new research assistants and coordinators;
• - Assist with scheduling and planning for visit capacity for assigned studies;
• - May set up, train and maintain all technology needed for studies;
• - May assist with study recruitment, patient enrollment, and tracking as needed;
• - May handle more complex study assignments and volumes;
• - May participate in community outreach/education events;
• - Maintaining confidentiality of patients, customers and company information, and;
• - Performing all other duties as requested or assigned.

Travel Clinical Research Coordinator

• publish content on external website (dcri.org) and intranet (Pulse) using content management systems (Drupal and SharePoint, respectively)
• create graphics for social media, external websites, and intranet
• determine requirements for instructional audiovisual media and coordinate production of slide series, films, videotapes and other media materials for use
• works both independently and collaboratively with internal Shared Services department, Production Designers and Marketing Managers on a wide mix of creative initiatives
• manage calendar of DCRI’s scientific conferences, researching Duke-related presentations at each show
• for scientific conferences at which DCRI has an exhibit booth, coordinate the marketing collateral needed for the booth
• prepares layouts, designs, artwork and formats for use in publication and/or exhibition design
• contribute to editorial planning by suggesting content ideas, target channels and audiences, and appropriate project timelines
• compile weekly internal newsletter in MS Outlook
• create quarterly external-facing newsletters using Constant Contact
• occasional content development for DCRI-owned external and internal channels
• serve as backup manager of DCRI’s social media channels (Twitter and LinkedIn)
• assist in the shooting and production of video and audio projects
• develop a broad knowledge of research conducted at the DCRI

Clinical Research Comm Specialist III

• Support current-state assessments of clinical research operations, workflows, and pain points
• Support efforts to document current state and design future state business processes
• Conduct stakeholder interviews, note-taking, and synthesis of findings
• Gather, organize, and analyze data related to study start-up, regulatory, financial, and operational processes
• Help develop client-ready deliverables such as summaries, recommendations, workflow maps, and presentations
• Assist with projects related to study activation, regulatory management, clinical operations, and research finance
• Track timelines, milestones, issues, and dependencies across project workstreams
• Contribute to identifying process improvement opportunities
• Prepare meeting materials, track decisions, and follow up on action items
• Maintain project trackers, risks, and status updates
• Support coordination across internal team members and client stakeholders

Education Research, Consulting Associate, 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

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