Job Description

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*

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:

1. Conduct site initiation, interim monitoring, and close-out visits in accordance with study protocols, Standard Operating Procedures (SOPs), and regulatory guidelines.
2. Perform routine monitoring activities, including source data verification, query resolution, and review of essential documents to ensure data integrity and protocol compliance.
3. Collaborate with investigative sites to provide training and support on protocol requirements, study procedures, and Good Clinical Practice (GCP) guidelines.
4. Act as a liaison between investigative sites and sponsor organizations, facilitating effective communication and resolving study-related issues in a timely manner.
5. Assist in the development and review of study documents, including informed consent forms, case report forms, and monitoring plans.
6. Ensure that study activities are conducted in accordance with project timelines, budgetary constraints, and quality standards.
7. Proactively identify potential risks and develop mitigation strategies to ensure the successful execution of clinical trials.
8. Participate in internal and external meetings, including investigator meetings, project team meetings, and regulatory agency inspections as needed.
9. Maintain accurate and up-to-date documentation of all monitoring activities in accordance with regulatory requirements and company policies.
10. Contribute to process improvement initiatives and best practice sharing within the clinical operations team.

Qualifications:

1. Bachelors degree in a scientific or healthcare-related field required.
2. 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.
3. Strong understanding of GCP guidelines, regulatory requirements (e.g., FDA, EMA, ICH), and industry standards pertaining to clinical research.
4. Proficiency in conducting monitoring visits, including site qualification, initiation, routine monitoring, and close-out activities.
5. Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders.
6. Detail-oriented with strong organizational and time management skills, capable of managing multiple priorities and deadlines.
7. Proven ability to work independently with minimal supervision, as well as part of a multidisciplinary team.
8. Willingness to travel domestically and internationally as needed (approximately 50-60% travel).

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