(Senior) Clinical Research Associate

3-6 years

$125,000 – $140,000

Redwood City

10 Feb. 18, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

(Senior) Clinical Research Associate
Location: Redwood City, CA
Posted: 1 week ago
Salary: $125K/yr - $140K/yr
On-site | Full-time

About Nuvig

Nuvig Therapeutics is dedicated to developing groundbreaking immune therapies for autoimmune diseases. Their focus is on creating treatments that minimize side effects compared to existing therapies. The company’s lead candidate NVG-2089 is in Phase 1b trials, marking an exciting step for the company in transforming patient care.

Position Summary

The (Senior) Clinical Research Associate (CRA) coordinates and oversees the planning, initiation, and management of clinical trials. This role involves managing trial enrollment, ensuring data quality, and maintaining strong relationships with investigational sites, while ensuring adherence to protocols, regulatory guidelines, and internal SOPs.

Responsibilities

Support study teams with adherence to timelines, budgets, and quality metrics.
Facilitate communication between sponsor, CROs, site personnel, and vendors.
Lead meetings, including development of meeting minutes and distribution.
Oversee study-level TMF and CRO management of documents.
Manage clinical trial systems and system access.
Contribute to the development and distribution of study newsletters.
Support internal site payment processes and reconciliation activities.
Participate in investigator meeting planning and vendor selection processes.
Track study metrics, such as site activation, enrollment, and CRF completion.
Assist with site budget development and negotiations.
Ensure essential documents are tracked and maintained across studies.

Knowledge and Skills Requirements

Bachelor’s degree in a scientific or health-related discipline.
Minimum of 3-6 years of clinical experience, with at least 2 years in clinical trial management.
Knowledge of GCP, ICH, FDA, EMA, and GDPR regulations.
Experience with clinical trial software and MS Office.
Ability to work independently and collaboratively, escalate issues, and manage risks.

What We Offer

Collaborative, data-driven environment with learning and development opportunities.
Competitive compensation including base salary, performance bonuses, and stock options.
Comprehensive benefits: medical, dental, vision insurance, 401(k) matching, and more.
Flexible work schedule with hybrid options.
On-site perks including free electric car charging and snacks.

About Nuvig Therapeutics

Founded in 2021, Nuvig Therapeutics is focused on revolutionizing treatments for autoimmune diseases. Backed by top investors, Nuvig is committed to advancing science and improving patient care with cutting-edge therapies.

Salary Range

The salary for this position is $125,000 – $140,000, based on factors such as experience, qualifications, and geographic location.

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(Senior) Clinical Research Associate

Job Description

About Nuvig

Position Summary

Responsibilities

Knowledge and Skills Requirements

What We Offer

About Nuvig Therapeutics

Salary Range

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