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SUMMARYThe Clinical Research Coordinator (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.Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned.<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>

U.S. Renal Care

Clinical Research Coordinator San Antonio

Job Description and RequirementsRandolph-Brooks Federal Credit Union is currently searching for an experienced and talented IT Problem and Change Management Manager to join our amazing Project Management Office team!&nbsp;The IT Problem and Change Management Manager will have the ability to work a hybrid schedule (remote/onsite) after a period of training (time frame may vary). Training will take place at the RBFCU Administrative Service Center: 1 Ikea-RBFCU Pkwy, Live Oak, Texas 78233. All applicants must reside within the state of Texas and have the capability of performing all of the work from their home in Texas.To successfully work from home, employees must have access to a minimum internet connection as noted by RBFCU. •&nbsp;&nbsp; &nbsp;Must have a reliable home internet provider and the ability to hard wire a connection directly to modem (Ethernet cable provided). •&nbsp;&nbsp; &nbsp;Must be able to provide a workspaces at home that is safe, suitable for work, and within a distraction free environmentThe IT Problem and Change Management Manager ensures stability, reliability, and continuous improvement of IT services and business operations, while minimizing disruptions and risks.This is a servant leadership role responsible for managing the change and problem management team and ensuring accuracy, timeliness and visibility of changes and their results as well as the thoroughness, promptness and transparent resolutions of problems..Essential Functions and Responsibilities:<ul><li>Provide managerial leadership and direction to the analyst team, including personal development plans, on-boarding training plan for new team members, and skills and quality assessment templates and reviews.</li><li>Develop, implement, and maintain department procedures for Problem and Change Management efficiency, in alignment with departmental objectives.</li><li>Review enterprise technology groups problem root cause analysis and reporting metrics for accuracy and completeness.</li><li>Facilitate IT Major Incident and IT Change Control Board meetings.</li><li>With senior leadership, track department Key Performance metrics.</li><li>Serve as project manager for designated regulatory or compliance efforts.</li><li>Assist the team with coverage as needed.</li><li>All other duties as assigned (note: essential functions and responsibilities may change or new ones may be assigned at any time with or without notice).</li></ul>Requirements:<ul><li>High School diploma or GED</li><li>Minimum five years of job-related work experience</li><li>Minimum 5 years’ financial institution experience</li><li>Minimum 5 years data analysis experience</li><li>Minimum 4 years of IT Service Management (ITSM) tools experience</li><li>ITIL Strategic Leader certification required</li><li>Required Project Management Professional (PMP) certification within 3 years of attaining position</li><li>Intermediate team leadership experience</li></ul>Skills and/or Certifications:<ul><li>Expert data analysis skills, including collecting and analyzing operational data, identifying trends and inefficiencies, and preparing reports and documentation</li><li>Ability to implement change management methodologies (ITIL, ADKAR, etc.) for an enterprise</li><li>Demonstrable proficiency in tools like Excel, Power BI, or similar for data visualization</li><li>Expert interpersonal, organization, and presentation skills</li><li>Intermediate analytics training skills</li><li>Professional verbal and written communication skills</li><li>Strong adaptability to change</li></ul>Preferred:<ul><li>Graduation from accredited college/university with associate’s degree in computer science, information technology, or related field. In lieu of associate’s degree, two years of related experience will equal to associate’s degree</li><li>Current CISSP or CCNP</li><li>CCDP a plus</li></ul>All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.

RBFCU

IT Problem and Change Management Manager

<h3>Job Description:</h3>To be eligible for consideration of this role, your primary residence must be located within a 90 mile radius at the time of application from the approved branch sites listed below: Edina, Oakdale, Minnetonka, Brookfield, MiddletonAs a Client Support Specialist, you will be an integral part of a fast-paced, team oriented environment that is focused on enhancing relationships with our high net worth clients who have assets of $250,000 to $1 million and therefore a complex service and investment need. In this role, you will help us to increase customer loyalty and drive business development opportunities.The Team While every Fidelity location has distinctive regional characteristics, each one embodies the core values that have been instrumental in building our proud past. Putting the customer first, respect, integrity, honesty, innovation and improvement as well as competitiveness are values shared across the organization. These simple but powerful values set us apart from our competition.The Expertise You Have<ul><li>Series 7 required</li><li>Series 63 or ability to obtain within 90 days</li><li>2-3 years of previous financial services experience</li></ul>The Skills You Bring<ul><li>Broad based knowledge and understanding of general financial planning concepts</li><li>Proven customer service, client support and problem resolution skills</li><li>Strong verbal and written communication skills</li><li>Ability to effectively influence others</li><li>Robust time management and organizational skills</li></ul>The Value You Deliver<ul><li>Engage with customers, via inbound calls, responding to their inquires which may include providing product and service level guidance, processing transactions to include options, equities, mutual funds and fixed income trades and other specialized monetary requests</li><li>Deliver efficient and responsive resolution for various client situations. Own the management of the case, research the issue and communicate the solution to the client</li><li>Uncover opportunities and identify products and services that will enhance the client’s financial success and partner with the Financial Consultant to further discuss with the client</li><li>Collaborate with internal business partners to research and resolve complex client requests</li><li>Conduct pro-active outbound calls to communicate resolution to the client or secure additional information to close out the request</li></ul><h3>Certifications:</h3>Series 07 - FINRA, Series 63 - FINRA<h3>Category:</h3>Customer ServiceMost 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.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.

Fidelity Investments

Client Support Specialist - San Antonio, TX Area (REMOTE)

Job Requirements This specific restaurant is independently owned and operated by a Whataburger franchise.&nbsp;Please click on the apply button below to be redirected to this franchisee’s website. Once there, you will be able to learn more about this position information and their application process.

5 Project Management / Professional Services Jobs in San Antonio, TX, USA