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Palo Alto Veterans Institute for Research Clinical Research Project Manager - Exercise Physiologist in Palo Alto, California

Palo Alto Veterans Institute for Research (PAVIR) supports the nation's second largest research program conducted among the VA Hospitals and the Suppes Lab is looking for a full timeClinical Research Project Manager - Exercise Physiologist. The Clinical Research Project Manager will manage all aspects of the study entitled, "Prehabilitation and Rehabilitation in PAD: A Randomized Exercise Intervention Trial (PREPARE-IT)" in the Cardiology Service. The assigned clinical role includes recruitment, enrollment, data collection procedures, data analysis and staff management/oversight. This position will support the Cardiology Division clinical research at the VA Palo Alto Health Care System (VAPAHCS), working closely with the Principal Investigator (PI), Dr. Jonathan Myers.

The Project Manager will liaise between the PI, Stanford IRB, patients, VAPAHCS clinical staff, VA RandD, PAVIR, Study Sponsors, and ORO, and update data regarding the study in various databases and reporting structures. The Clinical Project Manager is expected to assist in generating reports, internally, for the study sponsor (PCORI) and for publication. This Project Manager is also expected to support other study coordinators assigned to the PI's current and potentially new studies. The Project Manager is expected to work independently, and to serve as a role model to other study coordinators.

BENEFITS

PAVIR offersgenerous benefits, including comprehensive health insurance, vision, dental,14 paid holidays, paidvacation time, sick pay, a401(k) with a fully vested 6% company match and 3% profit share, a wellness program, commuter benefits, and professional development training. Plus, we pay for life, short-term disability, and long-term disability insurance.

JOB RESPONSIBILITIES

  • Study acquisition and design:Identify, research, and develop future clinical trials and funding with the PI for the center; Reviews project proposal or plan to determine time frame, funding limitations, procedures for accomplishing projects, staffing requirements, and allotment of available resources to various phases of projects. Participate in the design of guidelines for the collection of clinical data and administration of clinical studies, the preparation of protocols or modifications to study design; Contribute to the patient recruitment strategy and prepare associated materials for IRB submission, the development of forms, questionnaires, and the application of research techniques; Coordinate and implement procedures for data collection from patient charts, medical records, interviews, questionnaires, diagnostics tests, and other sources; Contribute to the assignation of duties to clinical trials staff.
  • Administrative and regulatory tasks to set up study:Establish work plan and perform all administrative and regulatory tasks associated with pre-study feasibility assessment and study kick-off meeting; Coordinate clinical trial budgets to advise Principal Investigator (PI), including integration of internal VAPAHCS resources in the efficient performance of study once initiated; Complete and coordinate study specific VA, PAVIR, and FDA regulatory and compliance tasks to support rapid start up; Complete all aspects of clinical trial registration; Complete and maintain external regulatory documents; Set up and maintain master trial documentation.
  • Compliance:Submit and coordinate local IRB and VA R/D submissions and coordinate responses to local IRB, VA Central IRB, and VA R/D requests for additional information; Review protocols for compliance with accepted research guidelines and ensure compliance with protocol guidelines and requirements of regulatory agencies and HIPAA regulations; Manage the study binder and serve as a point of contact for audits. Communicate with study sponsor, research collaborators and the FDA.
  • Enrollment and Study Participant communications:Identify and recruit study participants wit PI; Prepare case reports and consent forms; enroll potential subjects after obtaining informed consent; Communicate with and educate study subjects regularly via follow-up visits and telephone contact; Report adverse events to study sponsors and regulatory authorities in a timely manner.
  • Data collection and management:Code, evaluate, and interpret collected data and prepare appropriate documentation; Ensure data collection is compliant with protocol guidelines and requirements of regulatory agencies; Enter study data into electronic or paper study forms; Manage the database for internal and external audits and prepare summary reports; Coordinate the collection and analysis of biological samples and ensure proper specimen handling. Ensure study is data are securely stored according to VA guidelines.

QUALIFICATIONS

  • Required:Master's degree (or equivalent experience);
  • 7 years of experience as a clinical researcher in a complex clinical and research environment;
  • Clinical Exercise Physiologist Certification is desired.
  • Preferred:Degree in biological sciences, healthcare, or in a related field;
  • 10 years or more of experience in clinical research experience;
  • Excellent knowledge of study site perspective of Clinical Trials;
  • Knowledgeable in GCP, US FDA regulations, and ICH guidelines;
  • Good understanding of clinical terminology and procedures gained through experience;
  • Good leadership skills to provide coordination of study staff to accomplish study goals;
  • Experience with VA CPRS highly desired;
  • Demonstrated understanding of regulatory requirements regarding the clinical trial and IRB processes;
  • Ability to read and understand study/trial protocol;
  • Ability to lead and work on multiple projects and studies;
  • Demonstrated understanding of Use of Human Subjects in Research requirements;
  • Demonstrated ability to work independently and cooperatively;
  • Demonstrated ability to work and communicate effectively with study subjects;
  • Strong knowledge of SAS;
  • Proficiency with computers and database management;
  • Previous experience with CTMS, EDC, and other electronic case report forms;
  • Knowledgeable, with an ability to explain to others, in VA regulations and policies pertaining to clinical trials;
  • Proven track record towards meeting goals and deadlines;
  • Proficiency with Microsoft Word, Excel and PowerPoint.

ABOUT PALO ALTO VETERANS INSTITUTE FOR RESEARCH (PAVIR)

PAVIR facilitates research and education activities conducted at the VA Palo Alto Health Care System. At PAVIR we work with more than 160 uniquely talented medical scientists. We recruit and retain talented employees who believe in making a difference in the lives of others through innovative health research.

READY TO JOIN OUR RESEARCH TEAM?

If you feel that you would be right for this job, please fill out our initial3-minute, mobile-friendly application. We look forward to meeting you!

PAVIR is a nonprofit foundation affiliated with the Veterans Affairs Palo Alto Health Care System (VAPAHCS). As a condition of employment, all PAVIR employees are required to have an approved appointment with VAPAHCS andcomplete a background check before they can commence work.

PAVIR is pleased to be an Equal Opportunity Employer. Minorities, Women, Veterans, and Individuals with a Disability are encouraged to apply. We welcome and encourage diversity in the workplace regardless of race, color, religion, age, gender, sexual orientation, national orig

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