Clinical Research Coordinator Associate 2 (Fixed-term 12 months)

Stanford University; Stanford (CA); On-site; USD 84,856 - 97,021; Full time

Benefits offered by this job

Comprehensive Health Benefits

Retirement Plans

Flexible Work Hours

Professional Development Opportunities

Employee Discounts

Wellness Programs

Paid Time Off

Tuition Reimbursement

Research Funding

Access to University Facilities

Job summary

An established industry player is seeking a Clinical Research Coordinator Associate to lead complex clinical studies focused on surgical and ICU patients. This exciting role involves managing data, ensuring compliance with regulations, and collaborating with medical teams to enhance patient outcomes. The ideal candidate will have a Bachelor's degree and experience in clinical research, coupled with strong interpersonal skills and proficiency in data management. Join a dynamic team dedicated to advancing healthcare through innovative research and make a meaningful impact in the field.

Qualifications

• Bachelor's degree and 2 years of clinical research experience required.
• Strong interpersonal skills and proficiency with data management tools.

Responsibilities

• Oversee subject recruitment and ensure compliance with study protocols.
• Manage data collection and develop project schedules and budgets.
• Collaborate with medical teams and ensure regulatory compliance.

Skills

Interpersonal Skills

Data Management

Research Protocols

Regulatory Compliance

Medical Terminology

Education

Bachelor's degree in a related field

Tools

Microsoft Office

Database Applications

Job description

Clinical Research Coordinator Associate 2 (Fixed-term 12 months)

Thank you for your interest in Stanford University. At this time, Stanford has instituted a hiring pause for non-critical staff positions. The career page will be updated once the hiring pause has been lifted.

Job Summary

• DATE POSTED 1 day ago
• Schedule Full-time
• Job Code 4923
• Employee Status Fixed-Term
• Grade H
• Requisition ID 106201

The Department of Anesthesiology, Perioperative, and Pain Medicine, at Stanford University’s School of Medicine, is in search of a Clinical Research Coordinator 2 – Fixed-term 12 months (CRC2) to take on the responsibility of conducting clinical research and independently managing complex projects. The CRC2 will be instrumental in overseeing research studies primarily focused on surgical and ICU patients. Specific studies include evaluation of novel monitoring devices and both investigational drug and device studies focusing on novel treatments for acute kidney injury. The CRC2 will collect key study measures, maintaining the integrity of critical care research. The coordinator will be responsible for managing data related to study outcomes, ensuring that all source documents are complete and that participants adhere to study protocols, especially those specific to the ICU and OR environment. Regular collaboration with medical teams, including nurses and pharmacy staff, will be essential. The CRC2 will develop and maintain specialized databases, such as those tracking enrollment, ICU outcome metrics (e.g., ventilator days, organ failure scores), and lab specimen data. They will regularly evaluate data collection processes, identifying areas for improvement to ensure the accuracy and efficiency of study related data capture. Moreover, the CRC2 will oversee quality control, ensuring that team members’ data collection complies with Good Documentation Practices (GDP) and the ALCOA principles (Attributable, Legible, Contemporaneous, Original, and Accurate). Their role is crucial in maintaining the study's compliance, accuracy, and overall success in ICU patient research.

Duties include:

• Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
• Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data.
• Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes.
• Formally supervise, train, and/or mentor new staff or students, as assigned.
• Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes.
• 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.
• Ensure regulatory compliance. Regularly inspect study documents to ensure ongoing regulatory compliance.
• Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable.
• May require working extended or unusual hours based on research requirements and business needs.

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Strong interpersonal skills
• Proficiency with Microsoft Office and database applications.
• Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
• Knowledge of medical terminology.

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.

* - 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.

The expected pay range for this position is $84,856 to $97,021 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.