Clinical Research Associate (Contractor)

About this opportunity

At the company, we are seeking a Contract Clinical Research Associate to help grow the company Clinical Development team. The ideal candidate is well-organized, an excellent communicator and experienced in diagnostics clinical trial management. This person is responsible for all things related to assigned aspects of clinical trial monitoring and site management.  You are passionate about clinical research, attention to detail and Good Clinical Practice, and you will have a significant impact on the continued growth of an organization dedicated to changing the entire landscape of cancer.

The role reports to the Director of Clinical Operations, Dennis McHugh. This role will be a Remote role with occasional travel, as required, to our Brisbane, California headquarters.

What you’ll do

• Ensure compliance with standard protocol and regulatory and ICH GCP obligations in assigned aspects of clinical site monitoring, such as site initiation, routine monitoring, maintenance of study files, study close out, and retrieval of study materials.

• Complete on-site and remote monitoring activities in compliance with the Clinical Monitoring Plan, including source document verification for accuracy and integrity, as required.

• Write and submit reports of investigational site findings and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate.

Must haves

• Minimum Bachelor’s degree in a life science-related field, a registered nurse (RN) certification, or equivalent.

• 3+ years’ experience in a clinical trials research environment required, with specific in vitro diagnostics study experience.

• General knowledge of regulatory requirements & GCP.

• Ability to multi-task, deal with shifting priorities, and proactively solve problems/manage risks.

• Strong interpersonal, collaborative, and time management abilities.

• Excellent organizational skills; accurate and detail-oriented.

• High proficiency in Veeva Vault and Medrio.

• Strong spoken and written communication skills.

Nice to haves

• CRA certification by recognized professional organization is a plus, but not mandatory.

• Previous experience in the cancer early detection space.

Additional information

Contractors may be hired through a third-party provider and will be considered contingent workers. We invite you to check out our career page @ the company for additional company information.

The company is proud to be an equal opportunity employer and we value diversity. The company does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Applicants have rights under Federal Employment Laws.

• Family & Medical Leave Act (FMLA)

• Equal Employment Opportunity (EEO)

• Employee Polygraph Protection Act (EPPA)

California applicants please review the CCPA Notice at Collection here:

• California Consumer Privacy Act (CCPA)

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