Clinical Research Associate 9/7/2016
Santa Clara, CA
JOB DESCRIPTIONAPPLY CANDIDATES MUST HAVE RECENT SITE MONITORING EXPERIENCE IN MEDICAL DEVICE OR BIOTECH INDUSTRY.
* Hiring Manager is looking for candidates with clinical project management experience in clinical research, specific in either/or Pharma Clinical, Biotech ASCP or equivalent) or certification as a clinical research associate (CCRA) is desirable.
* Experience with IVD studies is desirable.
* 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.
* 5+ Years Experience Level
ADDITIONAL TRAVEL INFO
Please pass this along to your candidates regarding travelrequirements: For a typical study we would need the CRA to conduct
- Pre-qual visit: ~3 days (probably 1-2monthsbefore the initiation visit)
- Initiation visit: ~ 2 weeks
- Interim visit: about ~ 2-3 weeks after the initiation visit, this visit would last ~3-4 days (depending on the location)
- Additional interim visit: depending on the length of the study, may need to conduct another interim visit - again about 3 weeks after the 1st interim visit and again about 3-4 days
- Close-out visit: ~4 days
If these visit requirements are for each investigation site Yes
And are these sites located in vicinity or will require long distance travel. Depends on which site she/he is assigned
Will this be domestic and international travel Depends on which site she/he is assigned
How often is the international travel Same frequency of visits for domestic and international sites