Clinical Data Coordinator

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." 
 
Job Description: 
·         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. 
 
Responsibilities: 
·         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 
 
Desirable Qualifications: 
·         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 srini@apninc.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, 
Srinivas Mallipog 
Resource Executive 
APN Software Services, Inc (www.apninc.com
39899 Balentine Drive, Suite 385, Newark, CA 94560 
Phone: 510-623-5050- Extn 139 / Direct: 510-943-4054 
Fax: 510-623-5055 
Email Id: srini@apninc.com 

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