Clinical Research Nurse Specialist
5 days ago
We are seeking a highly skilled Clinical Research Nurse to join our team at Actalent. As a Clinical Research Nurse, you will play a critical role in ensuring the success of our clinical trials by coordinating team activities, planning logistical activities, and identifying risks to ensure compliance with protocols and regulations.
Key Responsibilities:- Coordinate team activities to ensure studies are carried out according to protocol, SOPs, and applicable guidelines and regulations.
- Plan logistical activities for procedures as per protocol and ensure thorough resource planning.
- Identify risks on study and ensure that actions are implemented to mitigate risks identified.
- Ensure study-specific training materials, documents, and records are prepared and delivered, or coordinates training, dry runs, simulations, and tests as required.
- Implement, monitor, and assess the need for training programs to maintain staff skill proficiency.
- Provide protocol-specific training to research study team and hospital/department staff directly involved with the care/treatment of research patients.
- Work with staff to assist with developing, updating, and implementing new Research Standard Operating Procedures, guidance documents, standard work, and workflows related to early-phase research.
- Coordinate, plan, implement, and evaluate nursing care to clinical trial study participants, including Adverse Event reporting and other support activities.
- Provide nursing-related care to clinical trial study participants as outlined in the study protocol.
- Coordinate and execute the collection, compilation, and analysis of clinical research data from studies conducted by PIs and study teams at the hospital and research institute.
- Interact with patients and families to recruit study subjects and ensure compliance with protocol guidelines and requirements of regulatory agencies.
- Attend and participate in investigator meetings, pre-study visits/initiation or coordinator meetings. Produce quality documentation, including completion of assessments within the specified time.
- Coordinate and be responsible for the collection of blood samples (PK samples and others), cultures, tissues, and other specimens as required by protocol.
- Prepare oral presentations/written reports/data requests describing progress, trends, and appropriate recommendations or conclusions as it relates to research.
- Communicate with the Sponsor or representatives regarding scheduling and facilitation of study monitor visits and facilitates communication between the organization and Sponsor or Sponsor's Representatives.
- Provide protocol and study feasibility input to the Leadership and Study Start-up Team.
- Work with QI/QA team to ensure quality standards are being met and reports adverse events, and protocol deviations.
- Ensure compliance with general and study-specific regulatory related processes with SOPs, FDA, NIH, and applicable regulations for the reporting of events to regulatory agencies.
- Assist with the design and implementation of protocols, forms/questionnaires, and the preparation of amendments to protocols and/or modifications to study design as appropriate for local, Investigator-Initiated studies.
- Bachelor's degree in Nursing (BSN)
- RN licensure within the State of Florida or Multi-State Enhanced Nursing License Compact (eNLC)
- IATA certification completion required within 3 months of hire date
- American Heart Association ACLS (Advanced Cardiovascular Life Support) certification - maintain active and in good standing throughout employment
- American Heart Association PALS (Pediatric Advanced Life Support) certification completion required within 6 months of hire
- American Heart Association BLS - maintain active and in good standing throughout employment
- 2-4 years of professional research or healthcare experience
- 1-3 years of Phase 1 clinical research experience
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation, and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion:At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information, or any characteristic protected by law.
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