- Provides clinical research support to Investigators/Sub-Investigators to prepare for and execute assigned research studies
- Administers rating scales for research participants
- Reviews study protocols, source document forms, other study-specific documents, and electronic data capture systems used to record clinical research data
- Collects and submits regulatory/ethics documentation as required by the Federal Drug Administration (FDA) and other regulatory bodies governing the conduct of the study
- Recruits and screens patients for clinical trials and maintain subject screening and enrollment logs
- Assists investigator in verifying that research study objectives are met on time and according to protocol requirements, clinical research regulations, and quality standards
- Maintains adherence to investigator site staff training requirements by auditing and maintaining training records
- Conducts rating scales for primary and secondary outcome measures as needed
- Maintains source documentation based on protocol requirements that adhere to Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) documentation principles
- Schedules and executes study visits and perform study procedures as delegated and supervised by the Principal Investigator
- Handles lab testing and analysis including collection and preparation of specimens and lab logistics
- Monitors subject safety and report adverse events and reactions to Principal Investigator, study team members, and IRBs as appropriate
- Performs a variety of clinical research procedures including but not limited to electrocardiogram (ECG), lab sample collection, vital signs, dose verifications and questionnaire administration
- Assists the investigators to safeguard the well-being of subjects and maintain standards required of clinical research sites
- Bachelor's Degree with 3 years relevant experience or equivalent combination of education & training
- Must have one year of rating experience with Alzheimer's trials.
- Advanced knowledge of the principles of Good Clinical Practices (GCP)
- Skill in carrying out required clinical procedures such as Phlebotomy, ECGs, etc.
- Sound knowledge of medical terminology
- Proficient in the use of technology
- Ability to work independently, prioritize actively, seek input, problem solve and work in a team environment
- Ability to maintain confidentiality
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients
- Certification of CCRC or CCRP preferred
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Clinical Research Coordinator - Napa, United States - Neurovations
Description
About Us:
Neurovations Research is a leading research organization dedicated to advancing medical knowledge and improving patient care in the field of pain management and neuroscience.
Our team of researchers, clinicians, and support staff collaborates on cutting-edge clinical trials and studies aimed at developing innovative treatments and interventions for individuals living with chronic pain and neurological disorders.
Join Our Team:
The Clinical Research Coordinator handles clinical trial administration for all protocol phases including rating.
Serves as a resource for study team members and principal investigators and assists with subject recruitment, data collection, scheduling of study-related activities and follow-up with enrolled subjects.
Assists in quality assurance/control of data resulting from studies. Provides cross-coverage for other CRCs within the department.Job Responsibilities:
Background and Responsibilities may include the following and other duties may be assigned:
Candidate Qualifications:
Job Type:
Full-time
To apply for the Contract Research Rater position with Neurovations Research, please submit your resume and a cover letter outlining your qualifications and relevant experience to We thank all applicants for their interest in joining our research team and will contact qualified candidates for further consideration.
