Clinical Research associate

Katalyst Healthcares & Life Sciences - San Diego, CA

Contract
Roles & Responsibilities:
Participates in the design, planning, implementation and overall direction of clinical research projects;
May co-ordinate the activities of relevant colleagues within the Company and external parties to ensure compliance with the overall scientific study objectives. May work with international investigators and key customers as well
Travels to field sites to monitor studies
Receives general instructions; plans and prepares studies
Reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents
Works with Data Management and Biostatistics staff on the design of documents and processes for the collection of study data from participating sites
Collects and maintains legal and regulatory documentation, as applicable
Assumes responsibility for training and coordinating certification of study site personnel
Ensures accurate and complete study management/data collection and transfer to data management
Ensures site compliance with regulations and study protocol
Monitors the sites and provides technical assistance, as necessary
Assists, prepares and manages study timelines
Manages material logistics for the studies
Conducts reference material testing in-house
Organizes investigator meetings, as necessary
Participates in Project Team Meetings
Keeps informed of trends and developments in clinical research
Knows and effectively uses the broad concepts of a particular field or specialization to resolve problems of limited scope and complexity
Analyzes alternative approaches to solve problems or develop new perspectives on existing solutions

Job Skills:
Excellent skills in basic computer applications (Word, Excel, Access, PowerPoint)
Excellent writing and verbal communication skills
Well organized and detail oriented
Impeccable record keeping and filing skills
Excellent time management skills

Education & Experience:
Bachelor's degree in scientific discipline or related field required, or equivalent combination of education and work experience
2+ years of experience in clinical study coordination, clinical site monitoring or clinical study management is required, 5+ preferred
Prior experience with current Good Clinical Practices (cGCP) and Code of Federal Regulations (CFR) is preferred
A background in biomedical/healthcare services with laboratory experience preferred
Ability to give presentations and teach others
Ability to work effectively in a team, and also work independently on assigned tasks