Clinical Research Associate - Discover International
Raleigh, NC 27601
About the Job
We are seeking an experienced Clinical Research Associate (CRA) to join our team to support Oncology Clinical Trials. this position is a 12 month contract role - highly extendable
The hourly rate for the role is between $35-50 per hour based on experience.
As a Clinical Research Associate (CRA) within our Oncology division, you will play a pivotal role in ensuring the successful execution of clinical trials in oncology. Working closely with cross-functional teams and investigative sites, you will be responsible for monitoring clinical trial activities to ensure compliance with protocols, regulatory requirements, and industry standards.
Key Responsibilities:
- Conduct site initiation, interim monitoring, and close-out visits in accordance with study protocols, Standard Operating Procedures (SOPs), and regulatory guidelines.
- Perform routine monitoring activities, including source data verification, query resolution, and review of essential documents to ensure data integrity and protocol compliance.
- Collaborate with investigative sites to provide training and support on protocol requirements, study procedures, and Good Clinical Practice (GCP) guidelines.
- Act as a liaison between investigative sites and sponsor organizations, facilitating effective communication and resolving study-related issues in a timely manner.
- Assist in the development and review of study documents, including informed consent forms, case report forms, and monitoring plans.
- Ensure that study activities are conducted in accordance with project timelines, budgetary constraints, and quality standards.
- Proactively identify potential risks and develop mitigation strategies to ensure the successful execution of clinical trials.
- Participate in internal and external meetings, including investigator meetings, project team meetings, and regulatory agency inspections as needed.
- Maintain accurate and up-to-date documentation of all monitoring activities in accordance with regulatory requirements and company policies.
- Contribute to process improvement initiatives and best practice sharing within the clinical operations team.
Qualifications:
- Bachelors degree in a scientific or healthcare-related field required.
- Minimum of 3-5 years of experience as a Clinical Research Associate (CRA) within the pharmaceutical, biotechnology, or CRO industry, with specific experience in oncology clinical trials.
- Strong understanding of GCP guidelines, regulatory requirements (e.g., FDA, EMA, ICH), and industry standards pertaining to clinical research.
- Proficiency in conducting monitoring visits, including site qualification, initiation, routine monitoring, and close-out activities.
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders.
- Detail-oriented with strong organizational and time management skills, capable of managing multiple priorities and deadlines.
- Proven ability to work independently with minimal supervision, as well as part of a multidisciplinary team.
- Willingness to travel domestically and internationally as needed (approximately 50-60% travel).
Source : Discover International