Research Project Coordinator – Entry Level
ONCOTherapeutics is a full-service Contract Research Organization (CRO) with a unique focus in the oncology therapeutic area. They are a strategic CRO running multiple clinical trials in community oncology sites throughout the United States (US). They 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, they provide real-world experience, data, and outcomes that lead to improved clinical utility of cancer therapies, enhancing the lives of cancer patients.
Our client hires exceptional people. They 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 an organized and detail-oriented Entry-Level Research Project Coordinator, you will assist behind the scenes in ensuring the smooth planning, organization, and execution of our clinical research studies. You will ensure compliance with all regulatory requirements and institutional guidelines while supporting the initiation, maintenance, and closure of clinical research trials. This includes managing site, sponsor, pharmaceutical, and external vendor start-up activities, ongoing maintenance tasks, and close-out processes.
To succeed, you should have:
- Solid organizational skills and attention to detail.
- A Bachelor’s degree in a relevant domain (e.g., Public Health, Life Sciences, or similar) is preferred. (or equivalent and relevant experience)
- Familiarity with platforms like Slack, Google Drive, clinical trial management systems (CTMS), data management platforms, and Salesforce
- Proficiency in both written and verbal communication.
- Ability to operate both autonomously and collaboratively within a team.
- Proven capability to manage multiple tasks and projects effectively.
- Must obtain Good Clinical Practice (GCP) & Human Subject Research (HSR) within 90 days of hire date
Study Coordinator’s responsibilities:
Project Coordination & Management:
- Assist in the planning and executing of clinical trials, ensuring adherence to study protocols, timelines, and budgets. Collaborate with project managers to facilitate smooth project execution and address any operational issues. Ensure all project activities align with organizational policies, research protocols, and regulatory standards.
Site Recruitment & Management:
- Support the recruitment of study sites by coordinating with potential sites and managing communications.
- Assist in evaluating and selecting sites based on their capabilities and suitability for the study.
- Facilitate site initiation activities, including site qualification visits, investigator meetings, and contract negotiations.
- Monitor site performance, ensuring adherence to protocol and addressing any issues.
- Provide ongoing support to sites, including resolving operational challenges and ensuring compliance with study requirements.
Vendor & Supply Chain Management:
- Coordinate with pharmaceutical and external vendors to procure and distribute study materials.
- Oversee the management of study kit supplies, including inventory control and distribution to study sites.
Data Collection & Management:
- Support collecting and verifying clinical trial data, ensuring accuracy and consistency. Input, manage, and maintain data within appropriate databases or data management platforms, ensuring accuracy and confidentiality.
- Assist in developing reports, manuscripts, and presentations based on the gathered data. Be able to present this data to the team every week.
Regulatory Compliance:
- Assist in preparing and submitting regulatory documents to institutional review boards (IRB) or other governing bodies.
- Ensure study compliance with federal, state, and institutional regulations and standards throughout the project lifecycle
- Maintain strict patient confidentiality according to HIPAA regulations, GCP, and ICH, 21 CFR.
Administrative Duties:
- Schedule, attend, and record minutes from team meetings, ensuring prompt follow-up on tasks and action items.
- Utilize Excel, Slack, Google Drive, and Salesforce-based CTMS tools for effective communication, data storage, and progress tracking.
Continuous Learning:
- Stay informed about industry trends, regulatory changes, and best practices in clinical research by participating in relevant workshops, conferences, and seminars as needed.
Best-in-Class Benefits and Perks:
We value their employees’ time and efforts. Their competitive compensation of $28 - $33 hourly, depending on experience 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 based on 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.
Qualified applicants with arrest or conviction records will be considered for employment with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
