Clinical Research Coordinator
Torrance, US-CA 90502
FT 100 % for 40-hours per week (regular full-time benefits)
# of Openings:
Minimum education requirements:
GED or high school diploma
11/9/18 10:46 AM
- Coordinates with Principal Investigator to help ensure that clinical research and related activities are performed in accordance with Federal regulations and LA BioMed and sponsoring agency policies and procedures.
- Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.
Preparation of Scientific Proposal
- Assists the PI in study feasibility assessments as requested.
Protocol Preparation & Review
- Reviews and comprehends the protocol.
- Attends investigator meetings as required or requested by the PI.
- Prepares other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
- Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.
Conduct of Research
- Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
- Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.
- Conducts or participates in the informed consent process including interactions with the IRB and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
- Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
- Coordinates participant tests and procedures.
- Collects data as required by the protocol. Assures timely completion of Case Report Forms.
- Completes study documentation and maintains study files in accordance with sponsor requirements and LA BioMed policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
- Retains all study records in accordance with sponsor requirements and University policies and procedures.
- Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
- Other duties as may be assigned (required)
Required Skills & Qualifications :
- GED or High School Diploma
- 3 months or more experience in a medical field (can include volunteer work) or as a clinical research coordinator
- General knowledge of medical terminology