Hiring _ Clinical Research Associate (CRA) - B _ San Diego, CA - 92121
Hiring _ Clinical Research Associate (CRA) - B _ San Diego, CA - 92121
Intellectt Inc
San Diego, CA
See who Intellectt Inc has hired for this role
Role: Clinical Research Associate (CRA) - B
Location: San Diego, CA - 92121
Duration: 05 Months on W2
Description
Member of the clinical team responsible for conducting Phase I-IV single or multi center studies according to Federal Regulations and ICH guidelines. Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions. Responsible for writing basic study protocols, monitoring or overseeing monitoring of investigational sites to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRFs from study sites, processing CRFs including data cleanup and classification of data, and completion of study summary. 3-5 Years Experience Level.
Top 3 Skills You’re Looking For On Resume
Intellectt INC
732 -769-3893 | EXT- 274
kalyan@intellectt.com intellectt.com/
517 Route 1 South, Suite 1115 Iselin, NJ 08830,
If you prefer not to receive further communications from us, kindly click :
UNSUBSCRIBE
Location: San Diego, CA - 92121
Duration: 05 Months on W2
Description
Member of the clinical team responsible for conducting Phase I-IV single or multi center studies according to Federal Regulations and ICH guidelines. Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions. Responsible for writing basic study protocols, monitoring or overseeing monitoring of investigational sites to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRFs from study sites, processing CRFs including data cleanup and classification of data, and completion of study summary. 3-5 Years Experience Level.
Top 3 Skills You’re Looking For On Resume
- on-site and remote monitoring experience 2-5 years.
- experience with study start up, monitoring, and close out activities
- ability to work independently, get training done and able to hit the ground quickly.
- Apply knowledge of FDA regulations to site monitoring and clinical study design duties.
- Monitor and maintain necessary supplies, with approval by senior department staff.
- Maintain effective, professional, timely, and consistent communications with clinical sites both in person, and via all available correspondence media (telephone, email, web, etc.)
- Support and/or lead clinical research study start up activities (includes creation of study binders, study logs, work instructions, case report form, and other study related materials)
- Ability to train site personnel on study activities including investigational product usage, maintenance and accountability, sample collection, testing and shipping, data entry and query resolution.
- Study monitoring (includes assessing the familiarity of the site personnel with the protocol, procedures, and investigational product, assessing protocol compliance and investigational product accountability as applicable, source document verification, identifying protocol deviations, writing queries, writing monitoring reports, notes to file, and other documentation as necessary)
Intellectt INC
732 -769-3893 | EXT- 274
kalyan@intellectt.com intellectt.com/
517 Route 1 South, Suite 1115 Iselin, NJ 08830,
If you prefer not to receive further communications from us, kindly click :
UNSUBSCRIBE
-
Seniority level
Associate -
Employment type
Contract -
Job function
Research, Analyst, and Information Technology -
Industries
Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing
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