Clinical Research Associate

0-3 years

$84,000 - $105,000

Remote

10 Aug. 20, 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

Position Overview:

Clinical Research Associate (CRA)
Location: San Diego, California
Travel: Up to 75%

Crinetics Pharmaceuticals, a pioneering company based in San Diego, is dedicated to developing innovative therapies for endocrine diseases and related tumors. Our commitment to rigorous scientific research drives us to create transformative treatments that significantly impact patients' lives. As we expand our operations, we seek a Clinical Research Associate (CRA) to join our dynamic team. This is an exciting opportunity to be part of a company known for its inclusive, patient-centered, and team-oriented culture. We are also a dog-friendly workplace, reflecting our unique and supportive work environment.

Position Summary:

As a Clinical Research Associate (CRA) at Crinetics, you will play a key role in the preparation and execution of Phase 1-3 clinical trials. Your responsibilities will include overseeing clinical investigations through site qualification, initiation, monitoring, and close-out visits. You will ensure that all monitoring activities comply with Good Clinical Practices (GCP) and the procedures established by Crinetics and partner CROs. Collaboration with the Clinical Trial Manager (CTM) and Clinical Monitoring management will be essential to meet study requirements and objectives.

Key Responsibilities:

Site Management: Develop and maintain strong, collaborative relationships with investigational sites throughout all trial stages.
Monitoring: Perform clinical study site management and monitoring activities in compliance with GCP/ICH requirements, SOPs, local regulations, and study protocols.
Documentation: Conduct site visits (qualification, initiation, interim, and close-out), ensuring accurate and timely generation of visit reports and letters.
Data Integrity: Review and verify study records including source documents, case report forms, and informed consent forms to ensure completeness and accuracy.
Compliance: Resolve data queries, address potential serious adverse events, and ensure proper investigational product handling.
Training: Train and assist site coordinators, investigators, and CRO staff in study procedures and protocol compliance.
Issue Resolution: Identify and address site performance, quality, or compliance issues, escalating as necessary.
Recruitment: Assist in the development and implementation of strategies for subject enrollment and recruitment.
Administrative Tasks: Manage visit information and documentation in Clinical Trial Management Systems (CTMS) and Trial Master Files (eTMF).

Education and Experience:

Required: Bachelor's degree in biological sciences or a related field with at least 2 years of experience as a Clinical Research Associate. Equivalent combinations of experience and education may be considered.
Skills: Demonstrated critical thinking, problem-solving, and advanced communication skills. Proficiency in GCP, ICH Guidelines, and regulatory requirements is essential.
Preferred: Experience in clinical study startup, execution, and close-out activities. Knowledge of risk-based monitoring processes is a plus.

Physical Demands and Work Environment:

Physical Activities: Prolonged periods of sitting, occasional walking, and lifting up to 25 lbs. Low to moderate noise levels. Accommodations may be provided for individuals with disabilities.

Compensation and Benefits:

Salary Range: $84,000 - $105,000, depending on experience and education.
Benefits: Includes a discretionary annual target bonus, stock options, Employee Stock Purchase Plan (ESPP), 401k match, comprehensive health insurance (medical, dental, vision, and life insurance), 20 days PTO, 10 paid holidays, and a winter company shutdown.

Equal Opportunity Employer:

Crinetics is an Equal Opportunity Employer. We provide fair employment opportunities to all qualified applicants without discrimination based on sex, sexual orientation, gender identity, race, color, national origin, disability, or any other protected characteristic.

Vaccination Requirement:

Crinetics requires all employees and contractors to be fully vaccinated against COVID-19 as a condition of employment. Exemptions may be requested for medical reasons or sincerely held religious beliefs.

Join Crinetics and contribute to advancing therapies that make a real difference in patients' lives. Apply now to be part of our dedicated team!

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Clinical Research Associate

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