Clinical Operations Specialist

Location
California, United States
Posted
09 Jan 2019
End of advertisement period
09 Mar 2019
Ref
81492
Contract Type
Fixed Term
Hours
Full Time

The Stanford Center for Clinical Research (SCCR) seeks multiple Clinical Research Operations Specialists to contribute toward coordination of complex and high-profile projects. Research may be conducted in a variety of therapeutic areas, including cardiovascular medicine.    Candidates must be comfortable working in a collaborative, fast-paced environment. Additional attributes include being highly detail-oriented and the ability to self-manage time. Strong verbal and written communication skills are also important in this role.  Ideal candidates have proficiency in Good Clinical Practice (GCP) and Good Documentation Practices (GDP), and experience in two or more of the following areas: 1) patient safety monitoring, 2) adverse event collection, 3) communicating with a variety of internal and external stakeholders, and 4) drafting study documents. Additional experience in clinical events adjudication, project management/operation metrics monitoring is desirable. The Clinical Research Operations Specialist I may also be responsible for ensuring adequate study start up, regulatory submissions and training for the study. This position may assist in the management of different phases of the study, from startup to closeout, and will ensure adherence to regulatory requirements.  

The mission of SCCR is to conduct high-impact, innovative clinical research to improve human health. SCCR is an Academic Research Organization within the Stanford Department of Medicine. SCCR leverages the physical and intellectual resources of Stanford University and its affiliated teaching hospitals and research centers to achieve its mission.   SCCR aims to find team members who are passionate about their work, are flexible, innovative, and want to deliver results. We place a high priority on equipping our team members to perform their job efficiently, helping them acquire new skills and grow within the organization. If you are looking to make a large impact through global-reaching clinical research in a rapidly growing academic research organization, we encourage you to apply! Learn more about our core values, who we are and what we do: med.stanford.edu/sccr.  

Duties include:

  • Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through closeout.
  • Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
  • Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure Institutional Review Board renewals are completed.
  • Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
  • Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
  • Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
  • Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
  • Participate in monitor visits and regulatory audits.
  • Other duties may also be assigned

DESIRED QUALIFICATIONS:

  • Demonstrated superb oral and written communication skills  
  • Project management experience
  • Clinical research experience  

Certification:

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

EDUCATION & EXPERIENCE (REQUIRED):

Two-year college degree and two years related work experience or a Bachelor's degree in a related field or an equivalent combination of related education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

  • Strong interpersonal skills.
  • Proficiency with Microsoft Office.
  • Knowledge of medical terminology.

CERTIFICATIONS & LICENSES:

Working toward certification(s) to perform basic patient measurements and tests, such as phlebotomy and EKG.

PHYSICAL REQUIREMENTS*:

  • Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
  • Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
  • Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.
  • 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 STANDARDS:

Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University’s Administrative Guide, http://adminguide.stanford.edu/.