Clinical Research Coordinator Associate

Location
California, United States
Posted
08 Oct 2020
End of advertisement period
08 Dec 2020
Ref
87364
Contract Type
Permanent
Hours
Full Time

Do you think rapid-acting treatments for psychiatric disorders are the future of applied neuroscience? We are looking for a highly motivated and personable Clinical Research Coordinator Associate (CRCA) to join the research group of Dr. Boris Heifets MD PhD in the Department of Anesthesiology at Stanford University School of Medicine. Dr. Heifets’ research group conducts both basic neuroscience and clinical research aimed at understanding how an emerging group of therapies, like ketamine and psilocybin, might function in the brain and how they could be used to outcomes for patient undergoing surgery and in chronic pain. This is an excellent opportunity to become a key player of a team thriving to make impactful contributions to the practice of perioperative medicine and pain management. 

Join a dynamic, highly collaborative research group as a clinical research coordinator. This job involves coordinating clinical care, patient recruitment, follow-up, and managing communications with IRBs, the FDA and the DEA. Our group is currently running two clinical trials, and collaborating with several other research groups on other trials. Direction and academic mentorship will be provided by the principal investigator, and opportunities for academic contributions are certainly available.

You will be responsible for day-to-day operations of two or more clinical studies, working with a highly collaborative team that includes Principal and co-investigators, fellow, residents, research nurse, medical students, and colleagues in the Psychiatry department at Stanford and UCSF, and Stanford’s Pain Medicine Division. Stanford University, located between San Francisco and San Jose in the heart of California's Silicon Valley, is one of the world's leading teaching and research universities. Since its opening in 1891, Stanford has been dedicated to finding solutions to big challenges and to preparing students for leadership in a complex world.

Supporting that mission is a staff of more than 10,000, which is rooted in a culture of excellence and values innovation, collaboration, and life-long learning. To foster the talents and aspirations of our staff, Stanford offers career development programs, competitive pay that reflects market trends and benefits that increase financial stability and promote healthy, fulfilling lives. An award- winning employer, Stanford offers an exceptional setting for professionals looking to advance their careers

DUTIES INCLUDE:

  • Serve as primary contact with research participants, sponsors, and regulatory agencies.  Coordinate studies from startup through closeout.  Work both independently and alongside other research team members and interface with colleagues in psychiatry and pain medicine to conduct research studies successfully from start to finish. CRCA will serve as liaison between study families and participants and research team. CRCA will assist other approved IRB studies too. CRCA will be responsible for independently leading participant assessments and appointments.
  • Determine eligibility via screening procedures, gather consent from study participants and execute according to study protocol; assist in development of recruiting strategies.  Interprets protocol with minimal guidance or oversight from investigator. Assists in recruitment, screening and enrolling participants in accordance with protocol and good clinical practices
  • 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. Manage the IRB protocol and submit any modifications and continuing reviews as requested. Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact. Maintain study data and regulatory documents; participate in planning and development of clinical studies, and pre-processing and analysis of data.
  • 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. Perform data extraction and collection, project data base monitoring, and assist in preparation of research findings.
  • Complete project-related administrative and budgetary responsibilities of a limited scope as needed.
  • Participate in monitor visits and regulatory audits. 

* - Other duties may also be assigned.

DESIRED QUALIFICATIONS:

  • Knowledge of principals of clinical research and federal regulations.
  • Ability to work effectively in a fast-paced environment with multiple projects and timelines.
  • Familiarity with IRB guidelines and regulations.
  • Previous experience with SPSS and other related database applications.
  • Previous experience working with Biobehaviorial studies and use of psychiatric scales.
  • Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
  • Fluency in Spanish as plus.

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.
  • Ability to work under deadlines with general guidance.
  • Ability to work with human study participants.

CERTIFICATIONS & LICENSES:

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

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 CONDITIONS:

  • Occasional evening and weekend hours.

WORK STANDARDS (from JDL)

  • 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.

Additional Information

  • Schedule: Full-time
  • Job Code: 4924
  • Employee Status: Regular
  • Grade: F
  • Requisition ID: 87364

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