Professional Case Management

Compensation

Full Description

Put your talents to work at PCM! Whether you work in our Home Care, Clinical Research, Impairments, or Catastrophic Care division, you will support our mission to deliver care and other services that enhance the quality of life of our clients. Be a part of our dynamic client-focused team and make a difference in your career! ESSENTIAL FUNCTIONS Updates Clinical Trials Management System (CTMS) as needed with essential profile information (CVs, medical licensures, laboratory accreditations), IRB status, consent form versions (protocol/consent form evolution), and safety information. Assists with regulatory actions during a Pre-Selection Visit (PSV) Upon site selection, prepares regulatory documentation packets and creates all FDA 1572 Forms for signature and IND filings. Distributes and tracks completion of financial disclosure forms, protocol signature pages, and Investigator Acknowledgements (as applicable) to obtain investigator and staff signatures. Other documents may be needed depending on type of trial. Assists with the completion of signature logs, training logs, and all regulatory documents, including the delegation of authority log (DOA) from study start up to study closeout. Assembles regulatory ‘binders’ both in the CTMS and Physical where mandated by a sponsor. Posts regulatory documents including protocols, amendments, consent forms, SAE forms, etc. in the CTMS and sends for signature as needed. Submit initial applications for study approval to the IRB. Submit continuing review reports, closeout reports, and other materials to the IRB for approval and process accordingly. Provides regulatory guidance / expertise in reviewing and submitting recruitment material as needed, for study related purpose or ad hoc. Prepares, maintains, updates, and audits study-specific regulatory files, IRB files per FDA guidelines and resolves queries, as necessary. Distributes IRB documentation and post IRB meeting information to study sponsors, research, and clinical staff accordingly. Communicate effectively with the company’s coordinators, Site managers, Project managers and management teams; pharmaceutical companies; CRO’s; IRBs; study sponsors, and other team members. Assists with archive and retention of both physical and digital trial documentation in accordance with regulations and study contract. Advise others on regulatory and compliance matters; provide subject matter expertise to cross functional teams. Actively participates in team meetings to bring forth new ideas, initiatives, and department goals. Helps develop and adheres to ongoing department KPIs. Identify and interpret relevant regulatory guidelines. Actively participates in process improvement and other initiatives within the department. Performs regular reviews on investigator site files to ensure compliance and audit / inspection readiness. Participation in audits and inspections by internal and external parties including regulatory bodies. May perform other duties not specifically listed in this job description as assigned by their immediate supervisor. The typical base pay range for this role is USD $72,300 - $105,700 per year. Individual base pay depends on various factors, in addition to primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience, skills and other market-based factors. Available Benefits Include Medical Dental Vision 401(k) Company Paid Short Term Disability Flexible Spending Account (FSA) Health Savings Account (HSA) Paid Time Off Voluntary Benefits Please contact Carson Moreira-Rego at (866) 776-0127 x387 or at Carson.Moreira-Rego@procasemanagement.com today to learn more about our opportunities where you can make a difference in your own career! Professional Case Management is an Equal Opportunity Employer. At Professional Case Management (PCM), our mission drives us. We have a growing team of over 4,000 employees who are passionate about delivering care that enhances the quality of life of clients in the most healing of environments – the home. We believe that aligning genuine, caring team members with this purpose is life-changing for our clients, customers, and teammates alike. And it’s our goal to consistently stretch ourselves – and the organization – to ensure we’re always learning, growing, and elevating our standards of service. In everything we do, we share a strong set of core values: We Work As A Team, We Do The Right Thing, We Figure It Out, We Pursue Growth, and We Take Ownership. PCM has been an industry leader in delivering specialized in-home care and other services to clients for over 30 years. Our Home Care division is the nation’s premier Home Healthcare provider to former nuclear weapons and uranium workers, upholding the highest standards of care through accreditation by the Accreditation Commission of Health Care (ACHC).