MUST have prior clinical research research experience to be considered!Job Description
Coordinates team activities to ensure studies are carried out according to protocol, standard operating procedures (SOPs), applicable guidelines and regulations, and within budget.
Plans logistical activities for procedures as per protocol and ensures thorough resource planning.
Identifies risks on study and ensures that actions are implemented to mitigate risks identified.
Ensures study-specific training materials, documents, and records are prepared and delivered, or coordinates training, dry runs, simulations, and tests as required.
Implements, monitors, and assesses the need for training programs to maintain staff skill proficiency, including annual validation and currency of required certifications and licenses.
Provides protocol-specific training to research study team and hospital/department staff directly involved with the care/treatment of research patients.
Works 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.
Coordinates, plans, implements, and evaluates nursing care to clinical trial study participants, including but not limited to Adverse Event reporting and other support activities.
Provides nursing-related care to clinical trial study participants as outlined (and applicable) in the study protocol.
Coordinates and executes the collection, compilation, and analysis of clinical research data from studies conducted by PIs and study teams at the hospital and research institute.
Interacts with patients and families to recruit study subjects and ensures compliance with protocol guidelines and requirements of regulatory agencies.
Attends and participates in investigator meetings, pre-study visits/initiation or coordinator meetings. Produces quality documentation, including completion of assessments within the specified time.
Coordinates and is responsible for the collection of blood samples (PK samples and others), cultures, tissues, and other specimens as required by protocol.
Prepares oral presentations/written reports/data requests describing progress, trends, and appropriate recommendations or conclusions as it relates to research.
Communicates 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.
Provides protocol and study feasibility input to the Leadership and Study Start-up Team.
Works with QI/QA team to ensure quality standards are being met and reports adverse events, and protocol deviations.
Ensures compliance with general and study-specific regulatory related processes with SOPs, FDA, NIH, and applicable regulations for the reporting of events to regulatory agencies.
Assists 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.
Hard Skills
Nursing
Clinical Research
Phase 1 Clinical Trials
Adverse Event Reporting
Specimen Collection
Data Analysis
Protocol Design
Soft Skills
Team Coordination
Risk Identification and Mitigation
Training Implementation
Patient Interaction
Communication
Quality Documentation
Additional Skills & QualificationsBSN – Bachelors of Science in Nursing RN Licensure within the State of Florida or Multi-State Enhanced Nursing License Compact (eNLC) – maintain active and in good standing throughout employmentIATA certification completion required within 3 months of hire dateAmerican Heart Association ACLS (Advanced Cardiovascular Life Support) certification - maintain active and in good standing throughout employmentAmerican Heart Association PALS (Pediatric Advanced Life Support) certification completion required within 6 months of hireAmerican Heart Association BLS - maintain active and in good standing throughout employment2-4 years of professional research or healthcare experience1-3 years of Phase 1 clinical research experienceAbout Actalent 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.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.