Clinical Research Associate (15 month contract)

CLINICAL OPERATIONS

Clinical Research Associate (15 month contract)

Office Location: Pasadena, CA or San Diego, CA

Clinical Research Associate (15 month contract)

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.

Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.

Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI and San Diego, CA. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

The Position

The Clinical Research Associate (CRA) provides support to Study Lead(s) in clinical study planning, execution and management. The primary purpose of the position is to support the COM/Study Lead in study set-up, execution, oversight, and closeout activities in compliance with the clinical protocol, regulatory requirements, ICH GCP guidelines and governing policies & procedures.

This role is a 15-month contract.

Responsibilities

Support assigned study teams with TMF set-up, maintenance, ongoing quality control reviews, and final

reconciliation of study documents

Routinely monitor TMF inspection readiness for assigned studies

Assist Study Lead with investigational product and ancillary supplies management, accountability and

reconciliation activities

Collect and/or review Essential Documents from investigational sites

Review informed consent documents for accuracy and completeness

Support investigator identification, feasibility, and activation activities

Review monitoring visit reports for accuracy and completeness

Support Study Lead in preparing materials for study-wide meetings (eg investigator meetings, interim

update meetings, data safety committee meetings, etc.)

Perform QC (formatting, spelling and grammar, accuracy, consistency) of study-level documents (master

ICFs, study plans, manuals, CRFs/CRF completion instructions, etc.) in alignment with study protocols

Contribute to the development of study-level documents ( study templates, manuals, guides,

newsletters, etc.)

Provide updates on study/site status as needed to ensure timely study entry and updates are reflected

on ClinicalTrials.gov or equivalent

Perform periodic data reviews as requested by Study Lead

Prepare and present updates at team meetings as assigned by Study Lead

Support central/referral laboratory set-up and on-time activation (eg specifications, user manual) as

delegated by the Study Lead

Work closely with CRO to plan for execution of study start-up and ongoing study execution activities as

assigned by the Study Lead.

Provide guidance and training to junior level team members as assigned by management

Recommend modifications to SOPs/work instructions (WIs) when necessary to improve compliance or

efficiency

Participate in process improvement projects including SOP/WI development

Maintain compliance with assigned procedures, guidelines, study plans and applicable regulatory

requirements.

Requirements:

2 years in clinical research

2 years as a Clinical Trial Associate; study coordinator

Proficient knowledge and understanding of ICH-GCP

Excellent interpersonal, verbal and written communication skills

Strong organizational skills and attention to detail

Ability to multi-task and prioritize appropriately

Preferred:

4-year college degree

CRA certification

California pay range

$85,000$100,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

All applicants must have authorization to work in the US for a company.