Clinical Research Nurse
4 weeks ago
We are seeking an experienced Registered Nurse to join our team at Medix™. This is a fantastic opportunity for a healthcare professional to transition into the Clinical Research space and collaborate on cutting-edge Oncology clinical trials.
Job Summary:The successful candidate will be responsible for conducting and managing multiple clinical trials from start-up to close-out in accordance with the study protocol, GCP, and company SOPs.
Key Responsibilities:- Implement and coordinate assigned clinical trials, including start-up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, conducting visits, ensuring data is entered in a timely manner, and resolving queries.
- Apply project management concepts to manage risk and improve quality in the conduct of clinical research studies.
- Develop, coordinate, and implement research and administrative strategies to successfully manage assigned protocols.
- Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.
- Apply good documentation practices when collecting and correcting data, transferring data to sponsor/CRO data capture systems, and resolving queries.
- Maintain confidentiality of patient protected health information, sponsor confidential information, and company confidential information.
- Verify and escalate patient safety concerns by ensuring all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with the protocol and company SOPs.
- Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner.
- Ensure staff are delegated and trained appropriately and documented.
- Create, collect, and submit regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations, and IRB requirements.
- Evaluate potential subjects for participation in clinical trials, including phone and in-person prescreens.
- Create and execute recruitment strategies defined by the Clinical Research Team.
- Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol.
- Understand product development lifecycle and significance of protocol design, including critical data points.
- Understand the disease process or condition under study.
- Collaborate with the Clinical Research Team to develop a Quality Control strategy for reviewing one's work on an ongoing basis and in preparation for monitor visits.
- Perform clinical duties, such as drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing, within scope.
- Other duties as assigned.
- Active RN license in the state of practice.
- Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances).
- Health Benefits / Dental / Vision (Medix Offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s)).
- 401k (eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1).
- Short Term Disability Insurance.
- Term Life Insurance Plan.
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