Clinical Trials Regulatory Project Manager

Job description

Clinical Trials Regulatory Project Manager🔍School of Medicine, Stanford, California, United States📁Research📅Sep 01, 2020 Post Date📅87195 Requisition #Grade: I

FTE: 100%

The Department of Pediatrics – Division of Gastroenterology, Hepatology & Nutrition, at Stanford University School of Medicine, is seeking a Clinical Trials Regulatory Project Manager (CTRS2) to perform comprehensive audits and monitoring of Stanford Investigator-initiated clinical trials conducted under IND or IDE, as well as oversee regulatory administration and compliance for clinical research. The Project Manager will perform extensive audits to determine compliance with IRB approved protocols, standard operating procedures (SOPs) and applicable regulatory requirements. The Project Manager will also direct pre-clinical IND-enabling studies of calcineurin pathway inhibitor intra-ductal, rectal and combination formulations as prophylactic agents for prevention of post-ERCP pancreatitis.

The Division of Gastroenterology, Hepatology and Nutrition advances the treatment of pediatric gastrointestinal and liver disorders through the coordinated efforts of its patient care, research and educational activities. Internationally recognized for its expertise in transplantation, gastroenterology and nutrition, the division’s clinical program at Lucile Packard Children’s Hospital Stanford cares for more than 10,000 patients each year, making it one of the largest programs in the country. As part of an academic medical center, researchers and clinicians continually work together to advance the standard of care. Exploring the molecular and genetic origins of conditions ranging from GI infections to transplant rejection, they transform their findings into the most advanced diagnostics, drug therapies and procedures available today.

Learn more about our team here: http://med.stanford.edu/gastroenterology.html.

Duties include:

  • Prepare regulatory submissions (such as IRB and IND/IDE) and applications and annual reports. Complete all related regulatory documents and maintain correspondence and telephone contacts with regulatory agencies. Submit annual reports and updates as required.
  • Serve as expert liaison in specialized compliance or scientific area between the investigators and regulatory agencies. Provide regulatory support, guidance, and information to principal investigators and research staff. May consult on protocol development.
  • Develop, deliver and manage tools to facilitate education and training, prepare written materials to communicate with research community including presentations, one-on-one training and orientation sessions.
  • Oversee and maintain regulatory documentation, safety reporting procedures and audit safety reports to ensure they are appropriately handled.
  • Evaluate and analyze the impact on new regulations and determine how to implement within unit. Apply knowledge of international, federal, state and local regulations as well as university policies to ensure optimal compliance.
  • Serve as primary liaison on safety issues and reporting procedures with the IRB, OSR, RMG or other internal organizations or committees.
  • May manage projects related to regulatory activities and clinical operations, develop the regulatory strategy for project teams.
  • May hire, orient, and provide ongoing training and direct supervision to regulatory staff. Assign work tasks, provide daily supervision of these tasks; provide verbal and written evaluation of work performance.
  • May contribute to establishing and developing Standard Operating Procedures for the conduct of clinical research. Ensure SOPs are compliant with international, federal, state, and local regulations, and consistent with the objectives of the clinical research operation.
* - Other duties may also be assigned

DESIRED QUALIFICATIONS:

  • Bachelor’s degree in scientific/health related field. Advanced degree preferred.
  • 10+ years preclinical research/development experience preferred, including relevant Preclinical Project Management experience and IND submissions.
  • Professional certification is preferred, as a clinical research professional, auditor, quality or regulatory professional
  • Familiar with Investigational New Drug procedures, study protocols, the informed consent process, Standard Operating Procedures (SOPs), and applicable regulatory requirements.
  • Proven auditing ability.
EDUCATION & EXPERIENCE (REQUIRED):

Bachelor’s degree and five years of related experience or a combination of relevant education and experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

  • Excellent communication and organizational skills and superb attention to detail.
  • Experience with MS Office products and database applications required.
  • Excellent inter-personal skills and customer service focus is required.
  • Experience in clinical research management and oversight, including project management in a dynamic research setting.
  • Strong knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice.
  • Experience in developing and implementing training/education.
  • Demonstrated ability to manage multiple projects and staff under varying time constraints.
  • Strong writing skills.
CERTIFICATIONS & LICENSES:

None

PHYSICAL REQUIREMENTS*:

  • Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten pounds.
  • Occasionally sit, use a telephone or write by hand.
  • Rarely kneel, crawl, climb, twist, bend, stoop, squat, reach or work above shoulders, sort, file paperwork or parts, operate foot and hand controls.
* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

WORKING CONDITIONS:

May require occasional local and overnight travel.

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Job No:
Posted: 9/10/2020
Application Due: 9/19/2020
Work Type:
Salary: