Title: Clinical Data Coordinator
Location: 3721 Valley Centre Dr, San Diego, CA 92130
Duration: 6 Months Contract
Schedule: 8 am to 5 pm (1st Shift)
Tax Term: W2
"U.S. Citizens and those authorized to work in the U.S. are encouraged to apply. We are unable to sponsor at this time."
· The Clinical Data Coordinator provides critical study conduct support through the basic clinical data reviews, query generation, reconciliation and reporting.
· Additional responsibilities include supporting clinical study team members in the completion and filing (paper and electronic) of clinical data, reports and administrative study documentation.
· Conducts basic clinical data review, query generation/resolution to support clinical study team activities according to SOP/WI and Data Management Plans.
· Assist with data reconciliation, e.g. core labs, central labs, images, FM data, inventory administration
· Support CRF development, database development, and testing on new studies
· Support maintenance, distribution and tracking of study status reports to clinical study teams, project teams, investigational sites and other stakeholders
· Support generation, distribution and tracking of clinical data reports to support management, project team, biostatistics, study reports, regulatory submissions and publications
· Trial Master File and Index maintenance - Supports and maintains documentation of all clinical research activities, e.g. site communications, correspondence, inventory information (paper and/or electronic)
· Supports and maintains investigational device administration including all documentation for forecasting, shipping, receiving, disposition, complaints, and returned good
· Supports site and vendor payment administration including study payments, PO maintenance, monthly reports for finance.
· Support assembly and distribution of department and study communications such at reports, newsletters and mass communications.
· Support department activities as required.
Minimum Qualifications, Knowledge, Skills and Abilities:
· Follows established SOPs and work instructions.
· Proficient computer skills including word processing, spread sheet generation and database querying and reporting skills.
· Good self-auditing skills and attention to detail
· Good oral and written communications skills (English)
· Ability to be point of contact for Clinical Research Associates for data related inquiries and data reporting.
· Organizational and project administration skills, tracking study activities for timeliness and completeness across multiple studies.
· BS degree in science or life science preferred
· 2+ years in related healthcare work experience or equivalent
· General understanding of US FDA regulations, ISO 14155, Good Clinical Practice and Japanese regulations.
· Experience in clinical database work and/or regulated environment
If you are available, interested, planning to make a change, or know of a friend who might have the required qualifications and interest, please send the updated resume to email@example.com
along with a best time and number to reach you.
Your prompt response is highly appreciated.
Thanks and have a blessed day ahead.
Thanks and Regards,
39899 Balentine Drive, Suite 385, Newark, CA 94560
Phone: 510-623-5050- Extn 139 / Direct: 510-943-4054