The Clinical Research Coordinator Associate is responsible for the overall management and implementation of an assigned set of multiple research protocols, assuring efficiency and regulatory compliance. These studies will be conducted at the Stanford Hospital and Clinics. He/she will work as part of a clinical trials research team and report to various Principal Investigators conducting clinical research.
Responsibilities include:
• Preparation of initial study documents for IRB submission in compliance with all local state and federal regulations. • Advising the IRB of amendment changes to the protocol and completing annual protocol renewals. • Recruiting, screening, and enrolling subjects in accordance with good clinical practice guidelines. • Collecting, recording, and maintaining complete data files using good clinical practice in accordance with HIPAA regulations. • Participating in data retrieval, reporting, and preparation of files and Case Report Forms for the various studies.
The successful candidate will interact with subjects by scheduling diagnostic and research evaluation visits, performing study-related assessments, including collection of blood samples and processing and shipment. The coordinator will oversee subject compliance to the study protocol, obtain information from the study subject regarding any changes in their medications or adverse events, and promptly report the findings to physicians for documentation in the subjects medical record. Reporting all serious adverse events promptly to investigators, sponsors, and the IRB is also a key responsibility.
Protecting the rights, safety, and well-being of human subjects involved in the clinical trials is a critical aspect of this role.
Duties include:
• Serving as the primary contact with research participants, sponsors, and regulatory agencies. • Coordinating studies from startup through close-out. • Determining eligibility of and gathering consent from study participants according to protocol. • Assisting in developing recruitment strategies. • Coordinating the collection of study specimens and processing. • Collecting and managing patient and laboratory data for clinical research projects. • Managing research project databases, developing flow sheets, and other study-related documents, and completing study documents and case report forms. • Ensuring compliance with research protocols and reviewing and auditing case report forms for completion and accuracy with source documents. • Preparing regulatory submissions and ensuring institutional Review Board renewals are completed. • Assembling study kits for study visits, monitoring scheduling of procedures and charges, coordinating documents, and attending monitoring meetings with sponsors, acting as the primary contact. • Monitoring expenditures and adherence to study budgets and resolving billing issues in collaboration with finance and/or management staff. • Interacting with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct. • Ensuring essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements. • Participating in monitor visits and regulatory audits.
Other duties may also be assigned.
Education & Experience Required:
• Two-year college degree and two years related work experience or a Bachelors 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:
• Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
Physical Requirements:
• Frequently standing, walking, twisting, bending, stooping, squatting, and using fine light and fine grasping. • Occasionally sitting, reaching above shoulders, performing desk-based computer tasks, using a telephone, and writing by hand, lifting, carrying, pushing, and pulling objects that weigh up to 40 pounds. • Rarely kneeling, crawling, climbing ladders, grasping forcefully, sorting, and filing paperwork or parts, and rarely lifting, carrying, pushing, and pulling 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:
• 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 Universitys Administrative Guide (http://adminguide.stanford.edu).
The expected pay range for this position is $34.56 to $40.30 per hour. Stanford University provides pay ranges representing its good faith estimate of the salary or hourly wage the university reasonably expects to pay for a position upon hire. 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 (http://cardinalatwork.stanford.edu/benefits-rewards) provides detailed information on Stanfords 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.