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<p>SUMMARY</p><p>The <strong>Clinical Research Coordinator</strong> (CRC) is responsible for the coordination of daily clinical trial activities. USRC has a research Partnership with the principal investigator (PI) and their physician practice. The local oversight and direction for activities related to the conduct of the clinical research is directed by the PI. The CRC will work collaboratively with the principal investigator (PI), the Sr. Clinical Research Coordinator (SCRC), the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial in accordance with the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations. The CRC will assist the PI in protecting the rights, safety and welfare of all study participants.</p><p>Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned.</p><ul><li>Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation.</li><li>Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46).</li><li>Assist in the process of maintaining and updating each study participant's source records, including collection of medical history, assessment of eligibility and documentation of all study related procedures and relevant information.</li><li>Promptly report adverse events, protocol deviations and unanticipated problems involving risk to human subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations (21 CFR 312), with assistance as applicable.</li><li>Ensure thorough, individualized, protocol-based study subject education on all study processes including but not limited to informed consent, study participation obligations, appropriate use of investigational product (IP), IP side effects and safety, communication with study staff and research rights.</li><li>Provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety.</li><li>Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protect participant confidentiality at all times.</li><li>Dispense, administer and instruct participants on proper use of the investigational product (IP) in accordance with the protocol, coordinator's scope of practice and at the direction of the PI, with assistance as needed.</li><li>Collaborate with the USRC clinical team. Participate in trial implementation, and ensure compliance with the study protocol by our clinical partners, with assistance as needed.</li><li>Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries and sponsor requests in a timely manner.</li><li>Aid in the coordination of long-term storage of research records in accordance with contractual requirements, with direction from the Director of Clinical Research.</li><li>Assist in the preparation of and attendance during site initiation meetings, monitoring visits, audit visits or regulatory authority inspections.</li><li>Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstrate compliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: Form FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional review board (IRB) related documents, IND reports delegation of authority (DOA), study specific enrollment logs, monitoring reports, with assistance as needed.</li><li>Assists in the coordination of efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution.</li><li>Fosters a patient-care culture that emphasizes patient safety and quality in all aspects.</li><li>Responsible for the patient stipend automated payment process including registration into the system and processing payments per the USRC policy and ongoing maintenance of payments during the trial.</li><li>Adheres to the USRC Research quality assurance program guidelines.</li><li>Travel to Investigator Meetings or similar research related meetings is required.</li><li>Travel may be required between dialysis facilities or nephrology practices within the community.</li><li>Develops a working knowledge of current clinical research practice standards and regulatory requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures and certifications.</li><li>May provide training and oversight of Clinical Research Coordinators and/or Research Assistants.</li><li>Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization.</li><li> Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures.</li><li> Participate in staff meetings as required.</li><li>Regular and reliable attendance is required for the job.</li><li>Actively promotes GUEST customer service standards; develops effective relationships at all levels of the organization.</li><li>Participates in team concepts and promote a team effort; performs duties in accordance with company policies and procedures.</li><li>Regular and reliable attendance is required for the job.</li></ul><br>

U.S. Renal Care

Clinical Research Coordinator Fort Myers South FL

<h3>Job Description:</h3><h3>Financial Consultant</h3><p>If you no longer want to spend your time on sourcing new clients and would rather have the time to deepen relationships and create complex financial plans, then join a team that is a stable industry leader. Fidelity provides a business model with an existing client base and institutional feeders of business that is unmatched in the industry. At Fidelity, we empower professional growth, flexibility and support thus enabling long-term success for you and our clients.</p><h3>The Purpose of Your Role</h3><p>Working in our Investor Center, you will engage face-to-face with your customers, offering guidance and personalized planning, while helping extend the reach of the firm's brand. We fully support you with an open architecture product platform and top resources in the financial industry, while you nurture relationships with an existing client base.</p><h3>The Expertise We’re Looking For</h3><ul><li>Previous success in building relationships, uncovering needs and recommending solutions</li><li>FINRA Series 7 &amp; 63 licensed; Series 65 or 66 licensed and appropriate state registrations OR ability to acquire series 65/66 upon hire</li><li>Keen ability to present complex solutions to a knowledgeable client base while building rapport and credibility</li><li>Degree and/or other professional certifications are helpful; if you do not already have a CFP or degree, our Tuition Reimbursement program can help you obtain one</li></ul><h3>The Skills You Bring</h3><ul><li>Ability to thoughtfully introduce your clients to different investment strategies and bring together additional client assets while engaging in positive, client-centered discussions</li><li>Being coachable, collaborative, and curious are your "go to" attributes</li><li>Committed to delivering an outstanding customer experience with a passion for seeing others thrive</li><li>Motivated by results and finding solutions, you take initiative and exceed customer expectations</li><li>Extensive knowledge of investment solutions</li></ul><h3>Our Investments in You</h3><p>Fidelity’s greatest advantage is our people, and we believe it is important to approach life holistically. We offer a competitive total rewards package, including a stable base salary, to recognize associate achievements. And our benefit programs are designed to help you and your family strike the right balance. We offer training in-branch, regionally, nationally, and virtually to help you with all aspects of your business. You will not fail due to a lack of training or onboarding!</p><h3>The Value You Deliver</h3><ul><li>Your integrity, insights, interpersonal skills, and meticulous planning allows you to mentor and support your customers as they look to reach their retirement goals</li><li>Supporting our clients by providing comprehensive investment solutions and retirement plans to meet their needs both now and for their future</li><li>Effectively engage clients through personal interactions, reflecting your interpersonal communication and relationship building skills</li><li>You have a steadfast commitment to your clients while making a positive impact in the community</li></ul><h3>Certifications:</h3>Certified Financial Planner ® / CFP-® - Issuing Authority, Series 07 - FINRA, Series 66 - FINRA<h3>Category:</h3>Sales<p>Most roles at Fidelity are Hybrid, requiring associates to work onsite every other week (all business days, M-F) in a Fidelity office. This does not apply to Remote or fully Onsite roles.</p><p>Please be advised that Fidelity’s business is governed by the provisions of the Securities Exchange Act of 1934, the Investment Advisers Act of 1940, the Investment Company Act of 1940, ERISA, numerous state laws governing securities, investment and retirement-related financial activities and the rules and regulations of numerous self-regulatory organizations, including FINRA, among others. Those laws and regulations may restrict Fidelity from hiring and/or associating with individuals with certain Criminal Histories.</p>

2 Project Management / Professional Services Jobs in Fort Myers, FL, USA