Site Manager
Care Access Research
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See open jobs at Care Access Research.See open jobs similar to "Site Manager" Getro.org.People & HR, Operations
Aurora, CO, USA
Posted 6+ months ago
What We Do
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.
Who We Are
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.
Position Overview
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.
What You'll Be Working On
Site Support Responsibilities:
-Supports Key Sponsors and CROs
-Manages some of the sites most challenging therapeutic areas and study designs
-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
-Assist Regional Site Manager and Quality Assurance Department with all Care Quality and FDA audits
-Assist other CRCs during their sponsor and study audits
-Develops and maintains CAPAs, when needed, with approvals from the Regional Site Manager
-Assume CTMS superuser status and assist others to ensure accuracy, compliance, and quality input
-Assist Regional Site Manager in performing Quality Control (QC) check of all study source documents for completeness and quality.
Personnel:
-Ensure HR policies are implemented and maintained at the site
-Work with site staff in annual training and documentation
-Encourage a positive team-oriented environment at each designated site
-Work with Regional Site Manager to ensure high staff morale and low turnover rates at designated sites
-Report to Regional Site Manager and all personnel issues at assigned sites
-Routine monitor office operations at assigned sites to ensure compliance with current policies and procedures and report any issues to Regional Site Manager
-Lead by example and display a high level of integrity and professionalism.
Financial:
-Work with Regional Site Manager to ensure timely responses to feasibility questionnaires and scheduling of site evaluation visits at assigned sites
-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
-Work with Regional Site Manager to identify and communicate staff needs as appropriate at assigned sites
-Report site needs to the Regional Site Manager.
Study Preparation:
-Ability to understand and follow institutional SOPs
-Review and assess protocol (including amendments) for clarity, logistical feasibility, safety, inconsistencies, etc.
-Assist PI and the Trial Activation Manager to ensure that all training and study requirements are met prior to trial conduct
-Discuss study medication, required procedures, eligibility criteria, and impact on office flow with Investigator and site staff
-Assist with planning and creation of appropriate recruitment materials
-Assist in the development of recruitment plan and obtain a listing of potential candidates to contact from the subject database
-Actively work with the recruitment team in calling and recruiting subjects for your studies and other site studies
-Attend Investigator meetings.
-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
-Assist in the creation or review of sponsor-provided protocol specific source documents
-Determine facility, equipment and outsource vendor requirements and availability
-Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access, and passwords)
-Ensure education of Assistant CRCs, CRC Is, site staff, and/or sub-investigators is completed for required tasks.
Study Management:
-Integrate new therapeutic, more complex trial load with existing trial load, delegate tasks as necessary, and prioritize activities with specific regard to protocol timelines
-Maintain organized files for blank source documents, patient charts, CRFs, and supplies
-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.
-Collect and evaluate concomitant medication
-Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during meetings
-Ensure trial activities are continuously discussed with covering personnel in preparation for vacation or sick leave
-Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
-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
-Maintain effective relationships with study participants and other Care Access personnel
-Interact in a positive, professional manner with patients, sponsor representatives, investigators, and Care Access personnel and management
-Communicate clearly verbally and in writing
-Accept accountability for actions and function independently
Patient Coordination:
-Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling a screening appointment
-Obtain informed consent per Care Access SOP and document process when revised ICF discussed with the patient during the course of the trial
-Administer delegated study questionnaires
-Collect and evaluate medical records
-Complete visit procedures and ensure proper specimen collection, processing, and shipment in accordance with the protocol
-Train others and complete basic clinical procedures, such as blood draw, vital signs, ECGs, etc.
-Review laboratory results, ECGs, and other test results (e.g. MRIs) for completeness and alert values ensuring investigator review in a timely fashion
-Learn to recognize adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify the Principal Investigator, Sponsor, and regulatory coordinator.
-Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in the protocol
-Schedule patients within visit windows, notify personnel as needed for procedures, and integrate visits with existing schedules to maximize efficient workflow and patient turnaround
-Dispense study medication per the protocol and/or IVRS systems. Educate patient on proper administration and importance of compliance
-Monitor patient progress on study medication.
Documentation:
-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
-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
-Maintain copies of all prescriptions written for study or non-study medication or procedures in the patient chart
-Accurately transcribe data to CRF. Resolve data management queries and correct source data as needed
-Record protocol exemptions and deviations as appropriate with the sponsor. Complete Memo-to-File for patient chart and regulatory filing if necessary
-Ensure all sponsor correspondence (e-mail, telephone conversations) are printed and given to appropriate personnel for regulatory filing
-Maintain copies of patient-specific correspondence in source charts
-Assist regulatory personnel with completion of continuing/final review reports
-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
Physical and Travel Requirements
This is an on-site position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.
What You Bring
-Excellent working knowledge of medical and research terminology
-Excellent working knowledge of federal regulations, good clinical practices (GCP)
-Understanding of issues affecting clinical research in the identified therapeutic area of expertise
-Ability and willingness to mentor and guide less experienced CRC as they develop and gain experience in all therapeutic areas
-Ability to communicate and work effectively with a diverse team of professionals
-Excellent organizational, prioritization, and leadership skills and capabilities with strong attention to detail
-Excellent computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word, and excel
-Critical thinker and problem solver
-Excellent interpersonal skills, detail-oriented and meticulous
-Friendly, outgoing personality with the ability to maintain a positive attitude under pressure
-High level of self-motivation and energy
-Excellent professional writing and communication skills
-Ability to work independently in a fast-paced environment with minimal supervision and also as a team player working together towards common goals.
Knowledge, Skills, and Abilities:
-BS in nursing, pharmacy or other related science or combination of equivalent education in the Arts or Sciences preferred
-Research Professional Certification- CCRC required
Certifications/Licenses, Education, and Experience:
-A minimum of 5 years of clinical research experience
-A minimum of 4 years prior Clinical Research Coordinator experience
Benefits (US Full-Time Employees Only)
· PTO/vacation days, sick days, holidays.
· 100% paid medical, dental, and vision Insurance. 75% for dependents.
· HSA plan
· Short-term disability, long-term disability, and life Insurance.
· Culture of growth and equality
· 401k retirement plan
Diversity & Inclusion
We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success. We do not discriminate based on race, sex, religion, color, national origin, gender identity, age, marital status, veteran status, or disability status.
At Care Access, every day, we are advancing medical breakthroughs. We’re uniting
standard patient care with cutting-edge treatments and research. Our work
brings life-changing therapies to those in need and paves the way for newer and
greater treatments to reach the world. We’re proud to advance these
breakthroughs and work with the big players while engaging with the best
physicians and caring for patients. Our team of experts is paving the way to
take this vision forward through innovation and a unique technology-enabled
service model.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
This job is no longer accepting applications
See open jobs at Care Access Research.See open jobs similar to "Site Manager" Getro.org.