Job Description
Actively looking to hire multiple CRCs to join a research organization in Miami FL! This is an URGENT need and will move quickly. This role is 5 days a week onsite working within pediatrics! Great opportunity if you are looking to work in clinical research! Apply today! Duties: - 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 activity 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 coordinate 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
- Works with staff to assist with developing, updating and implementing new Research Standard Operating Procedures, guidance documents, standard work and work flows (related to early phase research).
- Coordinates and executes the collection, compilation, and analysis of clinical research data from studies conducted by PIs and study teams
- 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 responsible for the collection of blood samples (PK samples and other), cultures, tissues and other specimens as required by protocol.
- Prepares oral presentations/written reports/data requests describing progress, trends and appropriate recommendations or conclusions
- Communicates with the Sponsor or representatives regarding scheduling and facilitation of study monitor visits and facilitates communication between PI and Sponsor or Sponsor's Representatives.
- Reviews protocol and provides study feasibility
- Ensures compliance of 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.
Qualifications: - At least 1 year of CRC experinece
- Bilingual in Spanish
- Reliable
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Job Tags
Local area, Immediate start,