Title: Sr. CRA 2, FSP - Oncology Location: Central & MidwestUnited States Work Type: Remote, Full Time Job ID: 262398 Job Description: Our FSP team is currently seeking a Sr. CRA 2 with 4+ years of monitoring as well as strong Oncology monitoring experience residing in the Central and Mid-West US. WHAT YOU WILL DO You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards. Responsibilities: - Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned - - Responsible for all aspects of site management as prescribed in the project plans - General On-Site Monitoring - Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study - Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements - Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document Monitor data for missing or implausible data - Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested - Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEs - Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management - Assist with training of new employees, eg. co-monitoring - Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned - Perform other duties as assigned by management Requirements - University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure) - 4+ years of Clinical Monitoring experience - Oncology experience is required - 60-70% overnight travel The important thing for us is you are comfortable working in an environment that is: - Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue. - Changing priorities constantly asking you to prioritize and adapt on the spot. - Teamwork and people skills are essential for the study to run smoothly. - Technology based. We collect our data directly into an electronic environment. Work Environment: - Work is performed in an office environment with exposure to electrical office equipment. - Frequent travel to clients/ site locations with occasional travel both domestic and international. Physical Requirements: - Ability to sit for extended periods and operate a vehicle safely. - Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. - Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. - Ability to access and use a variety of computer software developed both in-house and off-the-shelf. - Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. - Regular and consistent attendance. - Varied hours may be required. - Target Pay Range: $115 - $140K #LI - Remote

Provide high-level administrative support by managing incoming calls, scheduling patient appointments, maintaining accurate patient records, and ensuring prompt service to patients and referring providers within a clinical environment.

Provide comprehensive nutritional assessments and develop individualized care plans to enhance patient recovery. Collaborate with interdisciplinary teams to deliver education on nutrition strategies and contribute to quality improvement initiatives in...

• 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 • 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/Central Monitors) 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 • 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 • 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 • May 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.