Clinical Research Coord II Job at Integrated Resources, Inc in Miami

JOB DESCRIPTION
Job Description
Title: Clinical Research Coord II
Location: Miami, FL Onsite)
Duration: 6 Months W2 contract with high possibility of extension based on performance and depending on business needs
Shift: Monday – Friday ( Standard Shift)
Job Summary:
Clinical Research Coordinator (CRC) to support an ongoing study with data entry, query resolution, and other CRC activities.
The ideal candidate will have previous experience working as a CRC and demonstrate a strong collaborative approach.
They should be diplomatic, agile, and adaptable, with strong interpersonal skills and an ability to work effectively and constructively with different stakeholders.
Responsibilities:
* Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.
* Records all patient information and results from tests as per protocol on required forms.
* Where required, may complete IP accountability logs and associated information.
* Reports suspected non-compliance to relevant site staff.
* Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.
* Promotes the company and builds a positive relationship with patients to ensure retention.
* Attends site initiation meetings and all other relevant meetings to receive training on protocol.
* May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results.
* Logs/completes information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe.
* Gathers and maintains source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.
* Adheres to company COP/SCOP.
* May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility.
Required Skills:
* Bachelor's degree or equivalent and relevant formal academic/vocational qualification in the clinical/medical field.
* Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years').
* Solid understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.).
* Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving.
* Demonstrated ability to exercise discretion and sound judgement.
* Good decision-making, negotiation and influencing skills.
* Good communication skills and English fluency will be an advantage.
* Good organizational skills.
* Good proficiency in basic computer applications.
* Good interpersonal skills to work in a team environment.
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