Clinical Research Associate II

Job Summary of the Clinical Research Associate II

The Clinical Research Associate will function as the main point of contact for assigned sponsored and investigator- initiated studies. The CRA II will perform investigator site management activities in adherence to all applicable regulatory guidelines and standard operating procedures (SOPs) including site GCP compliance trouble shoot issues and facilitate resolution and monitor safety at the site. The position will also conduct site qualification visits as assigned site initiation visits and site training routine monitoring visits and site close-out visits. The CRA II will also act as a resource for new CRAs in setting a high standard for site management data review and SOP compliance. They will also assist as needed as a back-up resource for other clinical projects within Clinical Operations and assume accountability for assigned study site performance and begin to support the CRM on project-level tasks.

Requirements of the Clinical Research Associate II

• Bachelors degree required in a scientific or biomedical engineering discipline
• At least 3 years of Clinical Research Associate Research experience in device trauma orthopedic or reconstructive surgery is a preferred
• Independent judgment critical-thinking skills and discretionary decision-making
• Ability to multi-task and prioritize
• Excellent written & oral communication and presentation skills
• Must be willing to travel (50% of the time)

Responsibilities of the Clinical Research Associate II

The specific duties of the Clinical Research Associate II include but are not limited to:

• Interfaces with clinical sites/investigators on and off site as part of administrative site management to ensure compliance with protocols and regulatory compliance.
• Conducts site qualification initiation visits on-site monitoring visits co-monitoring visits and site closure visits of all phases of clinical trials. Assist with the resolution of data queries. Write site visit reports or reviewing monitoring reports provided by Contract Research Organizations (CRO).
• Performs CRA duties for more than one protocol or serves on more than one project
• Serves as a back-up resource for other clinical studies in Clinical
• Ensures compliance with protocol and all regulatory policies procedures and/or guidelines during clinical studies by providing: site training; guidance of investigators and site study team; and follow-up of correctiveactions.
• Ensures International Conference on Harmonization and Good Clinical Practice procedures are followed in all study aspects.
• Reviews study data for completeness accuracy and consistency with study
• Ensures timely subject recruitment and smooth implementation of studies by leading guiding and motivating site personnel to complete study goals.
• Ensures timely accurate collection of all adverse events adverse reactions and complaint reports and implement follow-up actions.
• Prepares reports of study progress to upper management
• Prepares and/or tracks required documentation for clinical sites (contracts budgets IRB documentation).
• Assists with information gathering literature searches data analysis report generation and creation of
• Assists with the development and maintenance of study
• Assists with preparation and execution of Investigator meetings including participation in presentation of study
• Assists as needed with orientation and onboarding and training of new CRAs
• Autonomously manages assigned sites and independently offers solutions to issues
• Assists in identifying and resolving solutions to project-level issues
• Manages documentation issues with CROs and/or study
• Complies with all company policies procedures and
• Other projects and duties as required/assigned.

Location

111 West Oak Ave. Tampa FL 33602

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Benefits/Compensation