• The Senior LTM role will be accountable/responsible for ensuring top-quality end-to-end trial delivery at a country level. • Managing the consistency of Local Trial Management duties and processes. • The Senior LTM will serve as the country-level single point of contact on the study for internal partners. • While the Sr LTM may delegate tasks to other LTMs or roles on the study, the Sr LTM remains accountable for successful completion of those tasks. • The Sr LTM will manage and oversee the following throughout the study: Central IRB and other local vendors, including set up of vendor purchase orders, invoice review and approval, and change-orders, as applicable. • Execution of local milestones from feasibility through study close out. • Resourcing of country-level roles, including support with transitions, in collaboration and agreement with the study Functional Manager (FM). • Inspection Readiness and AQR at the country level. • Close collaboration with the assigned Local Trial Manager(s), Lead Site Manager, Site Managers, Clinical Trial Associates, and Site Contract Managers to outline accountabilities/responsibilities and provide support and training, where necessary. • Efficient communication with the Clinical Trial Managers, Clinical Operations and the Global Trial Leader to oversee trial excellence. • Country level ad hoc meetings during any phase of the study that are needed to address unexpected circumstances that might impact country or study level deliverables. • Close partnership with the study FM to provide updates, discuss hurdles, timelines/resources, and potential risks, and assist with documentation, such as storyboards, lessons-learned, metrics, etc., that may be required by leadership. • Autonomy with execution of local trial management services. • Depth of knowledge with local trial management services. • Process leadership.

Role Description The VISN 8 Clinical Contact Center Pharmacy Service is seeking an experienced and dynamic overnight Pharmacist-Clinical Pharmacy Specialist. Ideal applicants are those who want to contribute to the achievement of quality care standards, as well as the growth and development of a VA academic hospital program. You must be an excellent communicator and team player who is able to perform all duties required of pharmaceutical care. This position is eligible for the Education Debt Reduction Program (EDRP), a student loan payment reimbursement program. You must meet specific eligibility requirements per VHA policy and submit your EDRP application within four months of appointment. Program Approval, award amount (up to $200,000) & eligibility period (one to five years) are determined by the VHA Education Loan Repayment Services program office after review of the EDRP application. Former EDRP participants ineligible to apply. Duties include but are not limited to: - Implementation and monitoring of therapeutic drug plans. - Obtain medication histories from patients and summarize significant findings in the medical record. - Serve as a provider with prescribing privileges as outlined in the individual's Scope of Practice. - Review Patient medical record and interview patients to detect drug-related problems. - Provide patient education about medications and related topics when appropriate. - Assess patients for drug therapy needs. - Serve as Pharmacist in charge in the absence of Pharmacy supervisor. - Conduct drug utilization review, quality assurance activities, and utilization reviews as required. - Document clinical interventions in CPRS in a timely and professional manner. - Promote and monitor compliance for established drug therapy policy. - Provide excellent customer service to Veterans, caregivers, and internal customers. - Ensure the V-IMPACT Hub Pharmacy Program is in compliance with all regulations and accreditations. - Assist in the coordination of V-IMPACT Hub Clinical pharmacy service including training residents and telehealth pharmacist. Work Schedule: 7 days on/7 days off (Overnight); from 7:00pm to 7:00 am. (Note: Work schedules are determined and approved by the supervisor. The incumbent may be required to work various shifts on a permanent or temporary basis based on facility/patient care needs). This is a virtual position. EDRP Authorized: Former EDRP participants ineligible to apply for incentive. Contact the VISN 8 Compensation Center of Excellence at VISN8CCOE@va.gov for questions/assistance. Permanent Change of Station (PCS): Not Authorized. Qualifications - Applicants pending the completion of educational or certification/licensure requirements may be referred and tentatively selected but may not be hired until all requirements are met. - United States Citizenship: Non-citizens may only be appointed when it is not possible to recruit qualified citizens in accordance with VA Policy. - English Language Proficiency: Pharmacists must be proficient in spoken and written English as required by 38 U.S.C. 7402(d), and 7407(d). - Education: - Graduate of an Accreditation Council for Pharmacy Education (ACPE) accredited College or School of Pharmacy with a baccalaureate degree in pharmacy (BS Pharmacy) and/or Doctor of Pharmacy (Pharm.D.) degree. - Graduate of foreign pharmacy degree meets the educational requirements if the graduate is able to provide proof of achieving the Foreign Pharmacy Graduate Examination Commission (FPGEC) Certification, which includes passing the Foreign Pharmacy Graduate Equivalency Examination (FPGEE) and the Test of English as a Foreign Language Internet-Based Test (TOEFL iBT). - Licensure: Full, current, and unrestricted license to practice pharmacy in a State, Territory, Commonwealth of the United States (i.e. Puerto Rico), or the District of Columbia. Must maintain current registration. Requirements - Experience: In addition to the GS-12 requirements, must have 1 year of experience equivalent to the next lower grade level. Duties include but are not limited to: - Reviewing, interpreting, and verifying medication orders for appropriateness. - Processing and filling medication orders. - Interacting with and making recommendations to other clinical staff regarding medication therapy ordered to ensure safe and effective care. - Reviewing the patient's medications, allergies, labs, and other pertinent information from the medical record to identify and solve medication-related problems. - Contacting providers as appropriate. - Documenting recommendations and interventions. - Knowledge, Skills, and Abilities: - Ability to communicate orally and in writing to both patients and health care staff. - Expert understanding of regulatory and quality standards for their program area. - Ability to solve problems, coordinate and organize responsibilities to maximize outcomes in their program area or area of clinical expertise. - Expert knowledge of a specialized area of clinical pharmacy practice or specialty area of pharmacy. - Advanced skill in monitoring and assessing the outcome of drug therapies, including physical assessment and interpretation of laboratory and other diagnostic parameters. - Preferred Experience: - Experience as Clinical outpatient Pharmacist at a VA facility or a Clinical Contact Center. - Experience working overnight independently. Physical Requirements Must pass a pre-employment physical examination as required by VA Handbook 5019. This examination is administered by VA Occupational Health. This position requires moderate lifting up to 44 lbs., carrying objects up to 15 lbs., frequent reaching above shoulder, use of fingers, hands and legs, use of cranes and motor vehicles, walking & standing up to 8 hours, bending and climbing and able to hear whisper. The incumbent must be physically, emotionally and mentally stable in order to efficiently perform the essential functions of this position without hazard to themselves or others.

Role Description The Department of Neurology is seeking a Research Navigator to support and coordinate work across more than 20 clinical sites nationwide. In this role, you’ll join a collaborative, high performing team dedicated to advancing and improving multi-site translational research. The Research Navigator works with investigators on project evaluation, trial simulation, and planning activities. Applies clinical trial design expertise and regulatory experience in working with IRBs, master/standard agreements and various grant mechanisms and funding agencies. The Research Navigator will have or develop a thorough knowledge and understanding of all programs and resources within the consult/grant mechanisms available to assist research teams. Will function as a liaison for inquiries related to receiving consult/grant support. Will work with leadership to identify problems and implement initiatives to ensure that timely and useful research support from the various consult/grant programs is provided to investigators. - Manage all aspects of the protocol optimization process: assembling project plans, team, and work assignments, directing and monitoring work efforts, identifying resource needs, performing quality review, and escalating functional, quality and timeline issues appropriately. - Manage investigator relationships. - Assist or serve as the consultation lead to determine with investigators the priority discussion topics to address during the consultation and organize the panel of expert consultants to accommodate the specific needs of each project. - Track consultations and resulting documentation through signature/approval processes and disseminate as appropriate. - Execute project management processes and methodologies to ensure consultations are completed on time, adhere to high quality standards, and benefit the investigative teams by ensuring a well-prepared grant application or smooth implementation of consult/grant services. - Serve as liaison and facilitate meetings between project stakeholders and leadership and complete and maintain professional documentation for projects and deliverables, develop Standard Operating Procedures as needed, assist in the auditing and monitoring of established workflows and processes. - Use professional judgment in handling information and be sensitive to project team, individual and all levels of organizational concerns. - Make use of data, statistical and quantitative analysis, explanatory and predictive modeling, and fact-based management to drive decision making. - Help investigators develop new insights and understanding of performance-based data during the consultation and grant production processes. - Other duties as assigned. In addition to the duties above: - Single-IRB (sIRB) coordination & regulatory submissions: preparing sIRB regulatory packets and compiling local context for initial/continuing review and reportable events for JHM sIRB. - Training participating site leads on sIRB procedures: designing and delivering guidance to 20+ sites to meet sIRB expectations and timelines. - Drafting informed consent documents: creating consent forms aligned with protocol and IRB requirements. - SOP development and process improvement for sIRB operations: building SOPs and refining workflows in collaboration with JHM sIRB leads to reduce approval delays. - Data-driven decision-making using statistical/predictive modeling: applying quantitative analysis to help investigators interpret performance data and drive decisions. Qualifications - Bachelor’s Degree in a related field. - Five years of experience in clinical research in an academic, government or pharmaceutical industry environment. - Additional education may substitute for required experience and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula. Requirements - Master’s Degree in a related field (Preferred). - Certification as a Clinical Research Professional (Preferred). Technical Skills & Expected Level of Proficiency - Attention to Detail - Intermediate - Clinical Research Knowledge - Intermediate - Clinical Study Design - Intermediate - Clinical Trials - Intermediate - Good Clinical Practices - Intermediate - Oral and Written Communications - Intermediate - Organizational Skills - Intermediate - Project Management - Intermediate - Research and Analytical Skills - Intermediate Benefits - Starting Salary Range: $64,600 - $113,300 Annually ($80,000 targeted; Commensurate w/exp.) - Employee group: Full Time - Schedule: M-F 8:30 am - 5:00 pm - FLSA Status: Exempt - Location: Remote - Department name: SOM Neuro BIOS - Personnel area: School of Medicine

Role Description The Department of Neurology is seeking a Sr. Clinical Research Manager for the BIOS Clinical Trials Coordinating Center (CTCC). The Sr. Clinical Research Manager works in collaboration with PI(s) to set the direction for research and is responsible for the overall management of a clinical trials portfolio and clinical research activities. - Collaborate with investigator(s) and exercise independent judgement in directing the conduct of the research. - Participate in scientific discussions with collaborators, PI's, and funding organizations and contribute to decisions impacting conduct of research. - Responsible for the recruitment, education, training and supervision of the clinical research coordinators and regulatory personnel within the program. - Responsible for development and implementation of policy and procedures for clinical research within the program. - Facilitate effective teamwork among all involved personnel, e.g. research staff, research nursing, data management, regulatory personnel, hospital staff, etc. - Ensure responsible conduct of clinical research protocols throughout the lifecycle, including development, implementation, maintenance, and termination. - Collaborate with PIs on research protocol development and evaluation, including reviewing and assessing new protocols for clarity, thoroughness, financial and logistical feasibility, maintaining subject safety etc. - Oversee preparation and submissions to IRB and act as liaison for regulatory issues on behalf of the PI. - Track and oversee the regulatory approval process to ensure efficient study startup; assist regulatory staff with informed consent and protocol amendments for investigator-initiated studies. - Manage clinical research budget generation and financial management of the program. - Ensure efficient use of centralized resources and adherence to policies as appropriate, e.g. clinical trial management system, prospective reimbursement analysis, etc. - Analyze resource utilization by individual trials to ensure research needs are anticipated and met. - Ensure adequate system for tracking and reporting clinical research milestones for financial invoicing. - Ensure the development, testing, and evaluation of manuals, questionnaires, and coding structures for the efficient collection of data. - Ensure research staff maintain complete and accurate research data and charts and are well prepared for auditing and monitoring visits. - Lead study meetings to examine data, decide on next steps, implement changes to protocol operations based on results and goals, and initiate sub-studies. - Contribute to manuscripts and presentations. - Other duties as assigned. Qualifications - Bachelor's Degree in a related field. - Six years of related experience in clinical research in an academic, government, or pharmaceutical industry environment. - Demonstrated supervisory or lead experience. - Additional education may substitute for required experience and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula. Requirements - Master's Degree in a related field. - Certification as a Clinical Research Professional. - Advanced knowledge of GCP/ICH and local regulations. - Formal project management training or certification. Technical Skills & Expected Level of Proficiency - Budget Management - Advanced - Clinical Resource Knowledge - Advanced - Data Management and Analysis - Advanced - Good Clinical Practices - Advanced - Finance Project Management - Advanced - Oral and Written Communications - Advanced - Program Development - Advanced - Record Keeping - Advanced Benefits - Starting Salary Range: $64,600 - $113,300 Annually ($89,000 targeted; Commensurate w/exp.) - Employee group: Full Time - Schedule: M-F 8:30 am - 5:00 pm - FLSA Status: Exempt - Location: Remote - Department name: SOM Neuro BIOS - Personnel area: School of Medicine