Clinical Research Coordinator 2 (Hybrid)

Details

Posted: 20-Mar-24

Location: Stanford, California

Type: Full-time

Salary: Open

Categories:

Staff/Administrative

Internal Number: 102592

Stanford Radiology is committed to providing exceptional patient care by leveraging technology, innovation, and compassion. We also aim to educate and train the next generation of leaders in patient care and research. Our research and development team is working on advanced technologies, including molecular imaging, in-vitro diagnostics, image-guided therapeutics, and informatics to improve precision health. We strive to foster a culture of diversity, inclusion, transparency, and integrity.

At Radiology, we are dedicated to recruiting team members who are enthusiastic about their work, adaptable, and enjoy achieving outcomes. We prioritize providing our staff with the necessary tools to perform their job effectively, assisting them in gaining new skills, and advancing within the organization. We believe in promoting a healthy work-life balance for our team and offer support to help achieve it. If you are interested in making a significant impact through clinical research with a global reach, we welcome you to apply!

The Senior Clinical Research Coordinator (CRC2) will work closely with the Investigator and Clinical Research Manager (CRM) in a dynamic environment. The CRC2 will be responsible for supporting multiple staff members, including coordinators, and working on multiple studies. The main responsibilities include developing recruitment and retention strategies, overseeing study operation and conduct, ensuring regulatory compliance and financial logistics, and ensuring overall progress on projects. The CRC2 will report project progress to the CRM and troubleshoot any barriers. The successful candidate should have outstanding communication and organizational skills, the ability to proactively manage challenges, a strong background in clinical research, and attention to detail.

This is a hybrid role.

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.
• Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.
• Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.
• Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones, and invoice sponsors according to study contract.
• Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory compliance.
• 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.
• Prepare monitor visits and regulatory audits.

*-Other duties may be assigned.

DESIRED QUALIFICATIONS:

Investigator Initiated clinical trial experience.

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor's degree in a related field and three years of experience in clinical research, or an equivalent combination of education and relevant experience. A Master's Degree in a relevant field is preferred.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, Scientific Review Committee, and Good Clinical Practices.
• Relevant work experience - i.e., in clinical research, device development, pharmaceutical industry etc.
• Demonstrated ability to establish priorities, manage shifting priorities, and handle numerous time-sensitive projects with multiple deadlines.
• Demonstrated experience working independently and as part of a team.
• Excellent interpersonal, written and oral communication skills.
• Proficiency with Microsoft Office and database applications.
• Knowledge of medical terminology.

CERTIFICATIONS & LICENSES:

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. May require a valid California Driver's License.

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:

• Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.
• May require extended or unusual work hours based on research requirements and business needs.

WORK 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 .

The expected pay range for this position is $72,000 to $92,000 per annum.

Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (https://cardinalatwork.stanford.edu/benefits-rewards ) provides detailed information on Stanford's extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.

Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a contact form .

Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

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.

Additional Information

• Schedule: Full-time
• Job Code: 4923
• Employee Status: Regular
• Grade: H
• Requisition ID: 102592
• Work Arrangement : Hybrid Eligible