Apply on Employer Site

Rovia Clinical Research · 23 hours ago

Clinical Research Coordinator

Jacksonville, FL

Full-time

Onsite

Entry Level

1+ years exp

Rovia Clinical Research is dedicated to advancing community clinical research by partnering with CROs, Sponsors, and PIs. The Clinical Research Coordinator role involves engaging with site operations and assisting in the coordination and execution of clinical studies, ensuring compliance with various guidelines and protocols.

BiotechnologyPharmaceutical

Responsibilities

Supports the preparation and conducting of site selection visits

Participates in study start up activities, including Source Data ID log, EMR questionnaire, Site Contact Sheet/Information Sheet, recruitment plan, Site Blinding Plan, delegation log, and temperature log

Participates in weekly site meetings

Supports the investigator signature process at their site

Assists with the establishment of a recruitment and contingency plan for studies

Monitors and assists with pre-screening/enrollment efforts for upcoming and enrolling clinical trials at the site

Supports the site in reaching study enrollment goals

Tracks enrollment goals per study and notify the management team immediately with any delays or changes concerning an enrollment goal by a sponsor, upon reaching set enrollment goals, any enrollment restrictions, and early enrollment closures

Identifies difficult to enroll studies and offers suggestions to improve enrollment in those studies

Completes EDC data entry and query resolution

Completes Clinical Conductor data entry and identifies potential missed revenue

Attends and supports study initiation visits, interim monitor visits, and study close out visits as necessary

Reviews site study monitor reports, working with the site staff as necessary to follow up on action items

Verifies with the Source Document Specialist that source documents are created and available for first patient visits

Develops a strong working knowledge of all site study protocols to ensure best direction and support to the site research staff

Performs direct follow-up on any subjects considering withdrawing and consults with the Research Manager when appropriate

Develops expertise in relation to platforms, including Clinical Conductor, Study Team, IRB, EDCs, Rovia SOPs/GDs, and other site practices

Assesses workflow processes and offers suggestions to the management team for recommended changes

Supports site resources through troubleshooting, communication, and providing recommendations to management

Acts as a positive role model for other site staff, helping to create a productive and optimistic working environment

Works with the Research Manager to identify, create, and maintain relationships with outside facilities as needed for different study protocols (i.e. ophthalmologists, MRI technicians, DEXA scan facilities, etc.)

May perform other job-related duties as requested or required

Qualification

ICH/GCP knowledgeClinical research experienceMedical terminologyRegulatory requirementsMicrosoft OfficeFluent in EnglishInterpersonal skillsOrganizational skillsConfidentialityTeamwork