- Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through close-out.
- Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
- 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.
- Bachelor's degree in a related field or an equivalent combination of related education and relevant experience; additional 1-2 years clinical trial experience preferred.
- 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.
- Strong interpersonal skills.
- Proficiency with Microsoft Office.
- Knowledge of medical terminology.
- Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
- 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.
- 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.
- Will be working at three different locations; Stanford Boswell Clinics, Portola Valley, and Santa Clara sites
- 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, .
- Freedom to grow . We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak.
- A caring culture . We provide superb retirement plans, generous time-off, and family care resources.
- A healthier you . Climb our rock wall, or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits.
- Discovery and fun . Stroll through historic sculptures, trails, and museums.
- Enviable resources . Enjoy free commuter programs, ridesharing incentives, discounts and more.
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Clinical Research Coordinator Associate - Stanford, CA, United States - Stanford University
Description
The Division of Cardiovascular Medicine , within Stanford University Department of Medicine, is a dynamic and innovative center dedicated to excellence in research, medical education, and clinical care. Our Division is driven by over 90 faculty members and a cadre of staff who are the pillar of strength in the Division's ongoing efforts into the prevention and treatment of cardiovascular disease.
We are seeking a Clinical Research Coordinator Associate (CRCA) who is passionate about clinical research and wants to deliver results. The CRCA will work with a robust clinical research team, hand in hand with Principal Investigators, Clinical Research Managers, Associates and other stakeholders in support of patients with lymphedema and other lymphatic disorders.
The Clinical Research Coordinator Associate will be responsible for the overall implementation of an assigned set of research protocols assuring efficiency and regulatory compliance. Other responsibilities will include recruiting, screening, assisting in the informed consent process and enrolling subjects in accordance with good clinical practice guidelines as well as collecting, recording and maintaining complete data files using good clinical practice in accordance with HIPAA regulations. The CRCA will participate in data retrieval, reporting, and preparation of files and Case Report Forms for the various studies. Other duties may include processing of blood samples, reporting serious adverse events and maintenance of drug accountability, supplies and equipment.
CV Med Clinical Research is a growing, dynamic team who is dedicated to supporting translational medicine and contributing to Stanford Medicine's mission. If you are eager to quickly achieve lasting results, we invite you to join our team
Duties include:
DESIRED QUALIFICATIONS:
EDUCATION & EXPERIENCE (REQUIRED):
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
CERTIFICATIONS & LICENSES:
PHYSICAL REQUIREMENTS:
WORKING CONDITIONS:
WORK STANDARDS:
The expected pay range for this position is $31.73 to $36.54 per hour.
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 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.
Why Stanford is for You
Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and unique perks empower you with:
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.
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 at For all other inquiries, please submit 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.