Clinical Research Associate; Oncology Monitoring Experience Required
Abarca HealthSalary not specified
Full Time
Mid-level (3 to 4 years)
Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Clinical Research, Pharmaceuticals, OncologyIndustries
Requirements
- Bachelor’s Degree (Degree in scientific discipline or health care preferred)
- Minimum of 1.5 to 2 years of relevant experience including on-site oncology monitoring experience
Responsibilities
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
- Collaborate and liaise with study team members for project execution support as appropriate
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the salary range for this Sr. CRA position?
The potential base pay range for this role, when annualized, is $69,800.00 - $226,800.00. The actual base pay offered may vary.
Is this position remote or does it require office work?
This information is not specified in the job description.
What experience is required for this CRA role?
A minimum of 1.5 years of on-site oncology monitoring experience is required, along with 1.5 to 2 years of relevant experience including on-site monitoring.
What education is needed for this position?
A Bachelor’s Degree is required, with a degree in scientific discipline or health care preferred.
What makes a strong candidate for this Sr. CRA role?
Candidates with a Bachelor’s Degree in a scientific or health care field and at least 1.5 years of on-site oncology monitoring experience will stand out.
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