Eximia Research · 2 hours ago
Clinical Research Coordinator
California, United States
Full-time
Onsite
Entry Level
1+ years expEximia Research is focused on conducting clinical trials, and they are seeking a Clinical Research Coordinator to manage these trials in accordance with established protocols and regulations. The role involves overseeing trial activities, ensuring patient safety, and maintaining compliance with documentation and reporting requirements.
BiotechnologyClinical TrialsTherapeutics
Responsibilities
Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Eximia Research Network’s SOPs
Perform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulations
Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable
Coordinate, with supervision, assigned clinical trials including start up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, conducting visits, participates in the ICF process(es), after visits, ensuring data is entered in a timely manner and all queries are resolved, managing, and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close out reports
Implement research and administrative strategies to successfully manage assigned protocols
Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors
Apply good documentation in accordance with ALCOA-C principles when collecting and correcting data, transferring data to sponsor/CRO data capture systems, and resolving queries
Maintain confidentiality of patient protected health information, sponsor confidential information and Eximia Clinical Network confidential information
Ensure patient safety is upheld and all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with the protocol and Eximia Clinical Network SOPs
Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner as set forth in the Clinical Trial Agreement
Ensure staff are delegated and trained appropriately and documented
Create, collect, and submit regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations, and IRB requirements
Evaluate potential subjects for participation in clinical trials including phone and in person prescreens
Execute recruitment strategies defined by Clinical Research Team
Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol
Perform clinical duties (e.g. drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope
Promote respect for cultural diversity and conventions with all individuals
Qualification
Required
Bachelor's degree with 1 year of relevant experience in the life science industry OR
Associate's degree with 2 years of relevant experience in the life science industry OR
High School Graduate and/or technical degree with minimum of 3 years relevant experience in the life science industry
Phlebotomy if applicable and required by state law
Intramuscular dose administration and preparation if applicable and required by state law
Demonstrated knowledge of medical terminology
Demonstrated ability in the use of the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone
Demonstrated ability to work in a fast-paced environment
Demonstrated verbal, written, and organizational skills
Demonstrated interpersonal and communication skills
Demonstrated ability to work as a team player
Demonstrated ability to read, write, and speak English
Demonstrated ability to multi-task
Demonstrated ability to follow written guidelines
Demonstrated ability to work independently, plan and prioritize with some guidance
Demonstrated ability to be flexible/adapt as daily schedule may change rapidly
Must be detail oriented
Demonstrated problem solving and strategic decision making ability
Proficient ability to accept individual responsibility for actions taken and demonstrate professionalism when judged, critiqued and/or praised
Sit or stand for long periods of time
Travel locally and nationally
Communicate in person and by a telephone
Limited to moderate walking required
Limited to lifting up to 30 pounds
Company
Eximia Research
Experience. Excellence. Exceptional Results.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
Veronis Suhler Stevenson
2023-10-04Private Equity
Company data provided by crunchbase