Clinical Research Associate
Onsite in West Hollywood, CA or Remote
ONCOtherapeutics is a full-service Contract Research Organization (CRO) with a unique focus in the therapeutic area of oncology. We are a strategic CRO running multiple clinical trials in community oncology sites throughout the United States (US). We provide the necessary support to major biopharmaceutical companies throughout the US to successfully run, enroll, and complete clinical trials. Uniquely focused on community-based Hematology & Oncology research sites, we provide real-world experience, data, and outcomes that lead to improved clinical utility of cancer therapies, improving the lives of cancer patients.
We hire exceptional people. We want individuals who thrive on being challenged and are passionate about building a great company and growing with us. If you want your next step to be the right one, and you've worked hard to get where you are today, then we have the perfect opportunity for you.
As the Clinical Research Associate, you will independently monitor clinical trial data by Good Clinical Practices (GCP), ICH, FDA, and internal standard operating procedures (SOPs). You will also conduct remote monitoring visits to assess protocol and regulatory compliance while ensuring patient safety. This includes source document verification, regulatory document review and management, and drug accountability. As a CRA, you will be the primary liaison between the sites and ONCOtherapeutics, ensuring questions and issues are resolved. You must clearly demonstrate the ability to manage multiple projects with different sponsors and timeline demands.
To succeed, you should have:
- Bachelor’s degree in a scientific discipline
- Minimum of two years experience in clinical research monitoring
- Therapeutic experience in oncology
- Proficient knowledge of Good Clinical Data Management Practices (GCDMP)
- Ability to perform all clinical monitoring activities independently.
- Ability to manage data for multiple protocols and unpredictable scenarios and achieve project timelines.
- Strong knowledge of electronic data capture (EDC) systems.
- Must work independently and establish and maintain effective working relationships with co-workers, supervisors, and other staff. Excellent interpersonal abilities are required.
- Basic medical/therapeutics area knowledge and understanding of medical terminology.
- Thorough knowledge of clinical research concepts, practices, GCDMP, FDA regulations, and ICH Guidelines regarding drug development phases, clinical research, and data management methods.
- Ability to maintain a working knowledge of multiple study protocols.
- Consistently meets goals and timelines; Effectively communicates issues that may hinder project timeline.
- Ability to solve problems. Must have effective time management, organizational skills, and superior attention to detail.
- Read, write, and speak fluent English. Excellent verbal and written communication skills.
- Excellent interpersonal skills and the ability to work well and flexibly, i.e., autonomously and in virtual teams in a cross-cultural environment.
Your responsibilities as the Clinical Research Associate will include:
- Review the performance of the trial at designated sites. Maintain regular communication with sites.
- Ensure the rights and well-being of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
- Carefully and thoroughly review source documentation to ensure the quality and integrity of the reported data on case report forms (CRFs). Generate queries and assist sites with resolution.
- Track and follow serious adverse events (SAEs), ensuring timely reporting to appropriate entities.
- Assists in resolving any issues to ensure compliance. Escalating issues to the Clinical Project Manager, as necessary.
- Conduct all aspects of site monitoring of clinical research studies according to Standard Operating Procedures, ICH Guidelines, and GCP.
- Collaborate with the Project Manager to determine study timelines and milestones.
- Assist the CTA with collecting regulatory documents and conducting an initial quality review.
- Assist the PM with building the study within the EDC and perform UAT as needed.
- Perform other duties as assigned by the Project Manager.
Best-in-Class Benefits and Perks:
We value their employees’ time and efforts. Their competitive compensation of $65,000-85,000 annually, depending on experience/location and extensive benefits package, enhances their commitment to your success. Our client’s benefits package includes:
- Comprehensive health coverage: Medical, dental, and vision insurance
- Retirement planning: 401(k) plan with employer matching
- Financial security: Life and disability insurance
- Flexible financial options: Flexible spending and health savings accounts
- Work-life balance: Generous paid time off and holidays
- Supportive resources: Employee assistance program
Plus, we maintain the best environment for their employees, where people can learn and grow with the company. They strive to provide a collaborative environment where everyone feels encouraged to contribute to their processes, decisions, planning, and culture.
We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do 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. We will consider qualified applicants with criminal histories for employment