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Site Manager

Care Access Research

Care Access Research

People & HR, Operations
Aurora, CO, USA
Posted on Friday, January 6, 2023
<div><b style="font-size:13pt;">What We Do</b></div><div><span style="font-size:12pt;">Care Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.</span></div><div><span style="font-size:12pt;"> </span></div><div><b style="font-size:13pt;">Who We Are</b></div><div><span style="font-size:12pt;">We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations. </span></div><div><span style="font-size:12pt;"> </span></div><div><b style="font-size:13pt;">Position Overview</b></div><div><span style="font-size:12pt;">Site Managers are responsible for the overall site conduct under the direction of the Regional Manager. The Site Manager is responsible for ensuring delivery of enrollment goals while maintaining adherence to FDA regulations, ICH guidelines, and CARE SOPs in all aspects of conducting clinical trials. The Site Manager is able to function and still partakes in all levels of a Clinical Research Coordinator.</span></div><div><span style="font-size:12pt;"> </span></div><div><b style="font-size:13pt;">What You'll Be Working On</b></div><div><span style="font-size:12pt;"> </span></div><div><b style="font-size:12pt;">Site Support Responsibilities:</b></div><div><span style="font-size:12pt;">-Supports Key Sponsors and CROs</span></div><div><span style="font-size:12pt;">-Manages some of the sites most challenging therapeutic areas and study designs</span></div><div><span style="font-size:12pt;">-Able to monitor and mentor all levels of CRCs to ensure a complete understanding of Care Access processes, SOPs, and values, ensuring that they are successful during their transition to more demanding opportunities and responsibilities</span></div><div><span style="font-size:12pt;">-Assist Regional Site Manager and Quality Assurance Department with all Care Quality and FDA audits</span></div><div><span style="font-size:12pt;">-Assist other CRCs during their sponsor and study audits</span></div><div><span style="font-size:12pt;">-Develops and maintains CAPAs, when needed, with approvals from the Regional Site Manager</span></div><div><span style="font-size:12pt;">-Assume CTMS superuser status and assist others to ensure accuracy, compliance, and quality input</span></div><div><span style="font-size:12pt;">-Assist Regional Site Manager in performing Quality Control (QC) check of all study source documents for completeness and quality.</span></div><div><span style="font-size:12pt;"> </span></div><div><b style="font-size:12pt;">Personnel:</b></div><div><span style="font-size:12pt;">-Ensure HR policies are implemented and maintained at the site</span></div><div><span style="font-size:12pt;">-Work with site staff in annual training and documentation</span></div><div><span style="font-size:12pt;">-Encourage a positive team-oriented environment at each designated site</span></div><div><span style="font-size:12pt;">-Work with Regional Site Manager to ensure high staff morale and low turnover rates at designated sites</span></div><div><span style="font-size:12pt;">-Report to Regional Site Manager and all personnel issues at assigned sites</span></div><div><span style="font-size:12pt;">-Routine monitor office operations at assigned sites to ensure compliance with current policies and procedures and report any issues to Regional Site Manager</span></div><div><span style="font-size:12pt;">-Lead by example and display a high level of integrity and professionalism.</span></div><div><span style="font-size:12pt;"> </span></div><div><b style="font-size:12pt;">Financial:</b></div><div><span style="font-size:12pt;">-Work with Regional Site Manager to ensure timely responses to feasibility questionnaires and scheduling of site evaluation visits at assigned sites</span></div><div><span style="font-size:12pt;">-Keep Regional Site Manager appraised of any study changes and all study-related issues that affect the performance of the site and the revenue generation of the assigned sites</span></div><div><span style="font-size:12pt;">-Work with Regional Site Manager to identify and communicate staff needs as appropriate at assigned sites</span></div><div><span style="font-size:12pt;">-Report site needs to the Regional Site Manager.</span></div><div><span style="font-size:12pt;"> </span></div><div><b style="font-size:12pt;">Study Preparation:</b></div><div><span style="font-size:12pt;">-Ability to understand and follow institutional SOPs</span></div><div><span style="font-size:12pt;">-Review and assess protocol (including amendments) for clarity, logistical feasibility, safety, inconsistencies, etc.</span></div><div><span style="font-size:12pt;">-Assist PI and the Trial Activation Manager to ensure that all training and study requirements are met prior to trial conduct</span></div><div><span style="font-size:12pt;">-Discuss study medication, required procedures, eligibility criteria, and impact on office flow with Investigator and site staff</span></div><div><span style="font-size:12pt;">-Assist with planning and creation of appropriate recruitment materials</span></div><div><span style="font-size:12pt;">-Assist in the development of recruitment plan and obtain a listing of potential candidates to contact from the subject database</span></div><div><span style="font-size:12pt;">-Actively work with the recruitment team in calling and recruiting subjects for your studies and other site studies</span></div><div><span style="font-size:12pt;">-Attend Investigator meetings.</span></div><div><span style="font-size:12pt;">-Coordinate and attend pre-study site visits, site initiation visits and monitor visits with clinical staff and Sponsor/CRO representatives and report summary to the Regional Site Manager if they are not in attendance</span></div><div><span style="font-size:12pt;">-Assist in the creation or review of sponsor-provided protocol specific source documents</span></div><div><span style="font-size:12pt;">-Determine facility, equipment and outsource vendor requirements and availability</span></div><div><span style="font-size:12pt;">-Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access, and passwords)</span></div><div><span style="font-size:12pt;">-Ensure education of Assistant CRCs, CRC Is, site staff, and/or sub-investigators is completed for required tasks.</span></div><div><span style="font-size:12pt;"> </span></div><div><b style="font-size:12pt;">Study Management:</b></div><div><span style="font-size:12pt;">-Integrate new therapeutic, more complex trial load with existing trial load, delegate tasks as necessary, and prioritize activities with specific regard to protocol timelines</span></div><div><span style="font-size:12pt;">-Maintain organized files for blank source documents, patient charts, CRFs, and supplies</span></div><div><span style="font-size:12pt;">-Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary. Document accountability log and patient records. Temperature monitoring and compliance of IP storage conditions.</span></div><div><span style="font-size:12pt;">-Collect and evaluate concomitant medication</span></div><div><span style="font-size:12pt;">-Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during meetings</span></div><div><span style="font-size:12pt;">-Ensure trial activities are continuously discussed with covering personnel in preparation for vacation or sick leave</span></div><div><span style="font-size:12pt;">-Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials</span></div><div><span style="font-size:12pt;">-Communicate sponsor updates, patient-specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of the Care Access team in an ongoing fashion</span></div><div><span style="font-size:12pt;">-Maintain effective relationships with study participants and other Care Access personnel</span></div><div><span style="font-size:12pt;">-Interact in a positive, professional manner with patients, sponsor representatives, investigators, and Care Access personnel and management</span></div><div><span style="font-size:12pt;">-Communicate clearly verbally and in writing</span></div><div><span style="font-size:12pt;">-Accept accountability for actions and function independently</span></div><div><span style="font-size:12pt;"> </span></div><div> <b style="font-size:12pt;">Patient </b><b><span style="font-size:16px;">Coordination</span></b><b style="font-size:12pt;">:</b> </div><div><span style="font-size:12pt;">-Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling a screening appointment</span></div><div><span style="font-size:12pt;">-Obtain informed consent per Care Access SOP and document process when revised ICF discussed with the patient during the course of the trial</span></div><div><span style="font-size:12pt;">-Administer delegated study questionnaires</span></div><div><span style="font-size:12pt;">-Collect and evaluate medical records</span></div><div><span style="font-size:12pt;">-Complete visit procedures and ensure proper specimen collection, processing, and shipment in accordance with the protocol</span></div><div><span style="font-size:12pt;">-Train others and complete basic clinical procedures, such as blood draw, vital signs, ECGs, etc.</span></div><div><span style="font-size:12pt;">-Review laboratory results, ECGs, and other test results (e.g. MRIs) for completeness and alert values ensuring investigator review in a timely fashion</span></div><div><span style="font-size:12pt;">-Learn to recognize adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify the Principal Investigator, Sponsor, and regulatory coordinator.</span></div><div><span style="font-size:12pt;">-Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in the protocol</span></div><div><span style="font-size:12pt;">-Schedule patients within visit windows, notify personnel as needed for procedures, and integrate visits with existing schedules to maximize efficient workflow and patient turnaround</span></div><div><span style="font-size:12pt;">-Dispense study medication per the protocol and/or IVRS systems. Educate patient on proper administration and importance of compliance</span></div><div><span style="font-size:12pt;">-Monitor patient progress on study medication.</span></div><div><span style="font-size:12pt;"> </span></div><div><b style="font-size:12pt;">Documentation:</b></div><div><span style="font-size:12pt;">-ALCOA-C: Record data legibly, in real-time on source documents; note additional information that may assist with the causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP</span></div><div><span style="font-size:12pt;">-Accurately record study medication inventory, medication dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmation is conducted in a timely fashion</span></div><div><span style="font-size:12pt;">-Maintain copies of all prescriptions written for study or non-study medication or procedures in the patient chart</span></div><div><span style="font-size:12pt;">-Accurately transcribe data to CRF. Resolve data management queries and correct source data as needed</span></div><div><span style="font-size:12pt;">-Record protocol exemptions and deviations as appropriate with the sponsor. Complete Memo-to-File for patient chart and regulatory filing if necessary</span></div><div><span style="font-size:12pt;">-Ensure all sponsor correspondence (e-mail, telephone conversations) are printed and given to appropriate personnel for regulatory filing</span></div><div><span style="font-size:12pt;">-Maintain copies of patient-specific correspondence in source charts</span></div><div><span style="font-size:12pt;">-Assist regulatory personnel with completion of continuing/final review reports</span></div><div><span style="font-size:12pt;">-Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive</span></div><div><span style="font-size:12pt;"> </span></div><div><b style="font-size:13pt;">Physical and Travel Requirements </b></div><div><span style="font-size:12pt;">This is an on-site position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.</span></div><div><span style="font-size:12pt;"> </span></div><div><b style="font-size:13pt;">What You Bring</b></div><div><span style="font-size:12pt;">-Excellent working knowledge of medical and research terminology</span></div><div><span style="font-size:12pt;">-Excellent working knowledge of federal regulations, good clinical practices (GCP)</span></div><div><span style="font-size:12pt;">-Understanding of issues affecting clinical research in the identified therapeutic area of expertise</span></div><div><span style="font-size:12pt;">-Ability and willingness to mentor and guide less experienced CRC as they develop and gain experience in all therapeutic areas</span></div><div><span style="font-size:12pt;">-Ability to communicate and work effectively with a diverse team of professionals</span></div><div><span style="font-size:12pt;">-Excellent organizational, prioritization, and leadership skills and capabilities with strong attention to detail</span></div><div><span style="font-size:12pt;">-Excellent computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word, and excel</span></div><div><span style="font-size:12pt;">-Critical thinker and problem solver</span></div><div><span style="font-size:12pt;">-Excellent interpersonal skills, detail-oriented and meticulous</span></div><div><span style="font-size:12pt;">-Friendly, outgoing personality with the ability to maintain a positive attitude under pressure</span></div><div><span style="font-size:12pt;">-High level of self-motivation and energy</span></div><div><span style="font-size:12pt;">-Excellent professional writing and communication skills</span></div><div><span style="font-size:12pt;">-Ability to work independently in a fast-paced environment with minimal supervision and also as a team player working together towards common goals.</span></div><div><span style="font-size:12pt;"> </span></div><div><b style="font-size:12pt;">Knowledge, Skills, and Abilities:</b></div><div><span style="font-size:12pt;">-BS in nursing, pharmacy or other related science or combination of equivalent education in the Arts or Sciences preferred</span></div><div><span style="font-size:12pt;">-Research Professional Certification- CCRC required </span></div><div><span style="font-size:12pt;"> </span></div><div><b style="font-size:12pt;">Certifications/Licenses, Education, and Experience:</b></div><div><span style="font-size:12pt;">-A minimum of 5 years of clinical research experience</span></div><div><span style="font-size:12pt;">-A minimum of 4 years prior Clinical Research Coordinator experience</span></div><div><span style="font-size:12pt;"> </span></div><div><b style="font-size:13pt;">Benefits (US Full-Time Employees Only)</b></div><div> <span style="font-size:10pt;">·</span><span style="font-size:7pt;"> </span><span style="font-size:12pt;">PTO/vacation days, sick days, holidays. </span> </div><div> <span style="font-size:10pt;">·</span><span style="font-size:7pt;"> </span><span style="font-size:12pt;">100% paid medical, dental, and vision Insurance. 75% for dependents.</span> </div><div> <span style="font-size:10pt;">·</span><span style="font-size:7pt;"> </span><span style="font-size:12pt;">HSA plan</span> </div><div> <span style="font-size:10pt;">·</span><span style="font-size:7pt;"> </span><span style="font-size:12pt;">Short-term disability, long-term disability, and life Insurance. </span> </div><div> <span style="font-size:10pt;">·</span><span style="font-size:7pt;"> </span><span style="font-size:12pt;">Culture of growth and equality</span> </div><div> <span style="font-size:10pt;">·</span><span style="font-size:7pt;"> </span><span style="font-size:12pt;">401k retirement plan</span> </div>
Care Access Research is an equal opportunity employer.
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