Clinical Research Coordinator Associate (1 Year Fixed Term)

at  Stanford University

The INSPIRE clinic is a person-centered program within the Department of Psychiatry and Behavioral Sciences which provides interdisciplinary and evidence-based care for people experiencing psychosis. We work with individuals, and their families, to achieve meaningful recovery from psychosis. We are also training a new generation of professionals and advancing knowledge through research.
The INSPIRE clinic is seeking to hire a Clinical Research Coordinator Associate (CRCA) to support several exciting studies and research projects within the clinic. The CRCA will work in a dynamic atmosphere and as part of a large team in a supportive environment. There will be the opportunity to work closely with fellow coordinators and research assistants, psychiatrists, psychologists and social workers. The CRCA will also support EPI-Cal, a statewide early psychosis training and technical assistance project, that collaborates with colleagues from UC Davis and UCSF. Direct patient recruitment and contact, along with data management is a primary responsibility of this role. The CRCA is required to have the ability to multi-task in a high-energy environment. A flexible work schedule, outstanding communication and organizational skills, and attention to detail are required in a successful candidate. The CRCA will be responsible for ensuring compliance with federal, state, local, and sponsor regulations and work independently under the direction of the supervisor.
This position will support a hybrid work arrangement. Interested candidates should include a cover letter and copy of their CV with their application.

Duties include:

• Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out.
• Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
• Coordinate collection of study specimens and processing.
• 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.
• 
  
• The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.

DESIRED QUALIFICATIONS:

Bachelor’s degree in related field

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.

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.
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• 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.

• Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out.
• Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
• Coordinate collection of study specimens and processing.
• 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.
• 
  
• The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned