Clinical Research Coordinator II (Must be Bilingual)

Care Access•Dallas, TX

4h•Onsite

About The Position

Care Access is dedicated to making the future of health better for all by bringing world-class research and health services directly to communities, ensuring every person has the opportunity to understand their health, access care, and contribute to medical breakthroughs. They achieve this through programs like Future of Medicine and Difference Makers, putting people at the heart of medical progress and reimagining how clinical research and health services reach the world. The Clinical Research Coordinator's primary responsibilities involve utilizing Good Clinical Practices (GCP)s to screen, enroll, and closely monitor clinical research study subjects while ensuring protocol and regulatory compliance.

Requirements

Bilingual in Spanish
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
A minimum of 3 years prior Clinical Research Coordinator experience
Recent phlebotomy experience
California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health
Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners
Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health
Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health

Nice To Haves

Bachelor’s Degree preferred, or equivalent combination of education, training and experience
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, required 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)