Clinical Research Associate; Oncology Monitoring Experience Required
Abarca HealthSalary not specified
Full Time
Mid-level (3 to 4 years)
Not SpecifiedCompensation
Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, Oncology, PharmaceuticalsIndustries
Requirements
- Bachelor’s Degree in a scientific discipline or health care (preferred)
- At least 1.5 years of on-site monitoring experience
- Good knowledge of GCP and ICH guidelines
- Good therapeutic and protocol knowledge (as provided in company training)
- Proficiency in Microsoft Word, Excel, and PowerPoint
- Experience with laptops, iPhones, and iPads (where applicable)
- Written and verbal communication skills
- Experience monitoring in oncology (preferred)
Responsibilities
- Perform site monitoring visits (selection, initiation, monitoring, and close-out) in accordance with contracted scope of work and regulatory requirements (GCP and ICH guidelines)
- Work with sites to adapt, drive, and track subject recruitment plans to enhance predictability
- Administer protocol and related study training to assigned sites and establish regular communication to manage project expectations
- Evaluate the quality and integrity of study site practices, escalating quality issues as needed
- Manage the progress of assigned studies by tracking regulatory submissions, recruitment, CRF completion, and data query resolution
- Support the start-up phase of studies
- Ensure site documents are available for the Trial Master File (TMF) and that the Investigator’s Site File (ISF) is maintained according to GCP and local regulatory requirements
- Create and maintain site management documentation, including visit reports, follow-up letters, and study documentation
- Collaborate with study team members for project execution support
- (Potentially) Support the development of a project subject recruitment plan on a per-site basis
- (Potentially) Manage site financial management according to the clinical trial agreement and retrieve invoices according to local requirements
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the salary for this CRA 2 position?
This information is not specified in the job description.
Is this CRA role remote or onsite?
The position is onsite and available on the U.S. East Coast, Central, or West Coast.
What experience and skills are required for this CRA 2 role?
Candidates need at least 1.5 years of on-site monitoring experience, preferably in oncology, good knowledge of GCP and ICH guidelines, proficiency in Microsoft Word, Excel, and PowerPoint, and strong written and verbal communication skills.
What education is required for this position?
A Bachelor’s Degree in a scientific discipline or health care is preferred.
What makes a strong candidate for this CRA 2 Oncology role?
Strong candidates will have at least 1.5 years of on-site monitoring experience, preferably in oncology, along with a Bachelor’s degree in a scientific field, knowledge of GCP/ICH, and proficiency in Microsoft Office tools.
IQVIA
Advanced analytics and clinical research services
About IQVIA
IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.
Durham, North CarolinaHeadquarters
1998Year Founded
$3,526MTotal Funding
POST_IPO_EQUITYCompany Stage
Cybersecurity, Biotechnology, HealthcareIndustries
10,001+Employees