Neuromuscular Clinical Research Coordinator Associate

1-2 years

$31.73 to $36.54 per hour

Stanford

10 Aug. 22, 2024

Job Description

Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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

Job Opportunity: Clinical Research Coordinator Associate (CRCA)

Location: Stanford University Medical Center, Unit 1
Department: Neuromuscular Division of Neurology
Role: Assistant Manager
Education Required: Two-year college degree with two years of related work experience or a Bachelor’s degree in a related field.
Experience Required: 7-12 years

Overview:

Stanford University’s Neuromuscular Division is seeking a Clinical Research Coordinator Associate (CRCA) to support research protocols focusing on neuromuscular disorders, including muscular dystrophies, spinal muscular atrophy, ALS, inherited neuropathies, and related conditions. This role involves coordinating industry-sponsored drug trials, including gene therapies and small molecule drug trials, and offers opportunities for long-term growth or a career launch in biomedical science.

Key Responsibilities:

Document Control:
- Review and approve SOPs, BMRs, and all quality documents.
- Check raw data and batch release data to ensure accuracy and integrity.
- Maintain electronic documents on the server.
Change Control, Deviation, and CAPA:
- Review and manage Change Control, Deviations, and CAPAs.
Self-Inspection:
- Prepare inspection schedules and conduct audits.
- Prepare and close out inspection reports.
Vendor Qualification:
- Assess vendors, perform audits, and sign Quality Agreements.
Validation Activities:
- Assist in validation activities, including reviewing qualification and validation documents.
Cell Bank Control:
- Oversee the receipt, storage, and documentation of cell banks.
GMP Compliance:
- Monitor compliance with cGMP regulations within the unit.
Authorization:
- Authorize QA documents as recommended by the Head of QA.
IPQA and Batch Release:
- Manage batch release processes and review IPQA observations.
Market Complaints and Recalls:
- Handle market complaints, recalls, and returns.

Desired Qualifications:

1-2 years of experience in data acquisition and processing with technical skill and attention to detail (e.g., MRI of brain or muscle).
Proficiency in basic programming and scripting (e.g., using R).
Technical skills and familiarity with imaging software (e.g., SPM, FSL, FreeSurfer).
Experience in cognitive testing.
Knowledge of database management, FDA regulations, IRB requirements, and the Stanford clinical research environment.
Ability to work independently and as part of a multidisciplinary team.
Experience with patients or research subjects.
Basic statistics knowledge.
Strong computer skills, including proficiency with Microsoft Office, and electronic data capture programs.
Excellent organizational and analytical skills, with attention to detail.

Education & Experience:

Two-year college degree with two years of related experience, or a Bachelor’s degree in a related field, or an equivalent combination of education and experience.

Certifications & Licenses:

Certification from the Society of Clinical Research Associates or Association of Clinical Research Professionals is preferred.

Physical Requirements:

Frequently stand, walk, twist, bend, and use fine grasping.
Occasionally sit, reach above shoulders, perform desk-based tasks, use a telephone, write by hand, lift and carry objects up to 40 pounds.
Rarely kneel, crawl, climb ladders, and perform tasks requiring forceful grasping.

Working Conditions:

Occasional evening and weekend hours may be required.

Salary and Benefits:

The expected pay range is $31.73 to $36.54 per hour.
Comprehensive benefits package provided. More details available on the Cardinal at Work website.

Application Instructions:

Interested candidates should submit a CV and cover letter detailing how their education and experience align with the position requirements.

Stanford University is an Equal Opportunity Employer and offers reasonable accommodations to individuals with disabilities. For accommodations, contact Stanford University Human Resources at stanfordelr@stanford.edu. For other inquiries, please use the contact form.

Note: Job duties are typical examples and may vary based on department needs. Employees may also perform additional duties as assigned.

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