Clinical Research Coordinator II (Must be Bilingual)

Care Access•Dallas, TX

1d•Onsite

About The Position

Care Access aims to improve health for all by providing world-class research and health services directly to communities, often overcoming barriers to care. They are committed to ensuring everyone can understand their health, access necessary care, and contribute to medical breakthroughs. Programs like Future of Medicine and Difference Makers highlight their focus on community health and medical progress. The company is reimagining clinical research and health services through partnerships, technology, and perseverance. The Clinical Research Coordinator's main role is to apply Good Clinical Practices (GCPs) to screen, enroll, and closely monitor clinical research study subjects, ensuring compliance with protocols and regulations.

Requirements

Bilingual in Spanish required
Ability to understand and follow institutional SOPs.
Excellent working knowledge of medical and research terminology
Excellent working knowledge of federal regulations, good clinical practices (GCP)
Ability to communicate and work effectively with a diverse team of professionals.
Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail
Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel.
Critical thinker and problem solver
Friendly, outgoing personality; maintain a positive attitude under pressure.
High level of self-motivation and energy
Excellent professional writing and communication skills
Ability to work independently in a fast-paced environment with minimal supervision.
Bachelor’s Degree preferred, or equivalent combination of education, training and experience.
A minimum of 3 years prior Clinical Research Coordinator experience required
Recent phlebotomy experience required
Licenses: California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health
Licenses: Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners
Licenses: Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health
Licenses: Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health

Nice To Haves

Bachelor’s Degree preferred
Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator

Responsibilities

Prioritize activities with specific regard to protocol timelines
Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.
Maintain effective relationships with study participants and other care Access Research personnel.
Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management.
Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)
Prescreen study candidates
Obtain informed consent per Care Access Research SOP.
Complete visit procedures in accordance with protocol.
Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.
Discuss study medication, procedures, eligibility criteria and impact on office flow with Investigator and site staff.
Record data legibly and enter in real time on paper or e-source documents
Accurately record study medication inventory, medication dispensation, and patient compliance.
Resolve data management queries and correct source data within sponsor provided timelines
Assist regulatory personnel with completion and filing of regulatory documents.
Assist in the creation and review of source documents.
Assist with planning and creation of appropriate recruitment materials.
Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.
Actively work with recruitment team in calling and recruiting subjects
Review and assess protocol (including amendments) for clarity, logistical feasibility
Ensure that all training and study requirements are met prior to trial conduct
Communicate clearly verbally and in writing
Attend Investigator meetings as required
Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)