Clinical Research Coordinator Associate, General Surgery (Hybrid Opportunity)

2+ years

Not Disclosed

Stanford

10 July 25, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Research Coordinator Associate (CRCA) - Stanford School of Medicine

Location

Stanford Campus, Hybrid (on-site and remote work subject to operational needs)

About the Role

The Division of General Surgery at the Stanford School of Medicine is seeking a Clinical Research Coordinator Associate (CRCA) to support the coordination of clinical studies. The CRCA will handle moderately complex aspects of one or more clinical studies under the close direction of the Principal Investigator and/or Study Manager/Supervisor.

Key Responsibilities

Primary Contact: Serve as the main point of contact for research participants, sponsors, and regulatory agencies, coordinating studies from initiation through to completion.
Participant Management: Assess participant eligibility, gather consent according to protocol, and assist in developing recruitment strategies.
Specimen Coordination: Oversee the collection and processing of study specimens.
Data Management: Collect and manage patient and laboratory data, maintain research project databases, develop study-related documents, and complete case report forms.
Compliance and Documentation: Ensure adherence to research protocols, audit case report forms for accuracy, prepare regulatory submissions, and manage Institutional Review Board (IRB) renewals.
Study Coordination: Assemble study kits, monitor procedure scheduling, manage study-related documents, and participate in sponsor meetings.
Team Interaction: Regularly interact with the Principal Investigator and/or Research Team to ensure patient safety and proper study conduct.
Record-Keeping: Ensure proper documentation and recording of patient and research data in compliance with institutional and regulatory requirements.
Additional Duties: Perform other related tasks as assigned.

Required Qualifications

Education:
- Two-year college degree with two years of relevant work experience, or
- Bachelor’s degree in a related field, or
- Equivalent combination of education and experience.
Skills:
- Strong interpersonal skills.
- Proficiency with Microsoft Office.
- Knowledge of medical terminology.

Desired Qualifications

Experience:
- Three years of experience in clinical research.
- Strong writing and editing skills.
- Comfortable with data extraction, management, and analysis.
- Fluent in Spanish (written and/or spoken) is a plus.
- Experience interpreting sponsor agreements and working with clinical trials, including protocol design and adverse health effects.
Certification: Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) certification is preferred.
Additional Skills:
- Ability to coordinate clinical trials independently and work effectively in a moderately autonomous environment.
- Flexibility and ability to manage multiple priorities with conflicting deadlines.
- Experience with research protocols and regulatory requirements, including HIPAA, FDA regulations, and Good Clinical Practices.

Physical Requirements

Frequent: Standing, walking, twisting, bending, stooping, squatting, and fine grasping.
Occasional: Sitting, reaching above shoulders, desk-based computer tasks, using a telephone, writing by hand, lifting and carrying objects up to 40 pounds.
Rare: Kneeling, crawling, climbing ladders, grasping forcefully, sorting and filing paperwork, lifting, carrying, pushing, and pulling objects over 40 pounds.

Working Conditions

Occasional evening and weekend hours.

Work Standards

Interpersonal Skills: Ability to work well with Stanford colleagues, clients, and external organizations.
Safety Commitment: Demonstrates commitment to safety, communicates concerns, and uses safe behaviors based on training and lessons learned.
Compliance: Expected to comply with all applicable University policies and procedures.

Compensation

Pay Range: $31.73 to $36.54 per hour. Final offer will be based on factors such as position scope, candidate qualifications, departmental budget, internal equity, geographic location, and market rates.
Benefits: Stanford offers a comprehensive rewards package including various benefits detailed on the Cardinal at Work website here.

Additional Information

The job duties listed are typical examples and not an exhaustive list. Duties may vary depending on department or program needs. Stanford University is committed to providing reasonable accommodations for individuals with disabilities. Applicants needing accommodation should contact Stanford Human Resources at stanfordelr@stanford.edu. For other inquiries, please submit a contact form.

Equal Employment Opportunity

Stanford University is an equal employment opportunity and affirmative action employer. All qualified applicants will be considered 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.

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