Clinical Research Assistant Bilingual - Doral, FL
1 day ago
Job description
The entry-level Clinical Research Assistant engages with site operations and assists in the development of the Rovia network, including planning, coordinating, and executing clinical studies in accordance with the protocol, contracted scope of work, ICH/GCP, sponsor, CRO, Rovia SOPs, and any relevant local guidelines and regulations.
Duties/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.
Required Skills/Abilities:
- Sound knowledge of medical terminology.
- Sound knowledge of ICH/GCP and Regulatory requirements.
- Excellent interpersonal and organizational skills.
- Proficient in the use of Microsoft Office and Excel.
- Fluent in spoken and written English and Spanish.
- Ability to work independently and in a team environment.
- Ability to maintain confidentiality.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Education/Experience:
- High school diploma required, bachelor's degree in related field of study preferred.
- 1+ years of clinical research experience preferred.
- Phlebotomy or Medical Assistant certification or experience, as required by county authorities to perform clinical tasks.
- License/Certification status with appropriate CEUs, if applicable.
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