Home-based Clinical Research Associate (cra) -- Northern California -- Immediate Need!!
Kelly Scientific Resources (Silicon Valley/San Jose, California)

CLINICAL RESEARCH ASSOCIATE (CRA) ' Northern California Every day, Kelly Scientific Resources (KSR) Clinical Research connects scientific professionals with opportunities to advance their careers. We currently have an exciting long term contract opportunity for a Home-Based Clinical Research Associate (CRA) with at least 3 year of monitoring experience. We are looking for a self-starter who lives anywhere within California. Candidates must have prior monitoring experience and previous experience with the therapeutic area of Oncology is preferred. This is a contract positions scheduled to last for 18 months.  The hired candidate must be willing to travel 50-75% of the time.  For immediate consideration, click the 'Apply Now!' button, or refer a friend by clicking the 'E-mail this job' link provided. JOB RESPONSIBILITIES: ' The Clinical Research Associate (CRA) is responsible for facilitating the clinical investigator selection process, managing patient enrollment and overseeing the clinical trial process utilizing fundamental principles of monitoring at the study site from site selection to closeout ' Will be responsible for identifying, evaluating and qualifying potential investigators ' Will be accountable for site-specific enrollment ' Will identify, define, coordinate and conduct site study training ' Will verify or review clinical report forms (CRF) via source data according to the monitoring plan ' Will manage CRF backlog and facilitate query resolution ' Will ensure drug accountability is complete and accurate ' Compliance to Good Clinical Practices (GCP), International Conference on Harmonization (ICH) guidelines, U.S. Food and Drug Administration (FDA) regulations, applicable policies and procedures ' Will generate and distribute monitoring visit reports ' Will conduct site closeout and assure appropriate archival of regulatory documents ' Will maintain inspection readiness at the site level ' Will serve as primary point of contact for site personnel regarding study or process-related issues ' Will ensure proper escalation of site-related issues according to global and local procedures ' Will ensure site level metrics are tracked and communicated as appropriate ' Will maintain corporate asset protection at all times ' Will maintain timely interaction with internal and external customers ' Will provide timely completion of all administrative tasks (e.g. calendaring, expense reports, time entry, training) ' Will be accountable for meeting monitoring timelines and metrics including CRF and query cycle time and enrollment, and last CRF in house commitments for data locks JOB REQUIREMENTS: ' Must have at least 3 year experience as a CRA ' Must have prior monitoring experience ' Must be willing to travel approximately 50-75% ' Four-year degree, in a project management, health-related or scientific field ' Oncology clinical trial experience or relevant clinical development experience preferred ' Knowledge of GCP's, FDA regulations and ICH guidelines ' Strong leadership, interpersonal skills and leadership ' Excellent oral and written communication skills ' Strong problem-solving skills ' Demonstrated ability to articulate issues ' Excellent self-management and organizational skills ' Detail oriented ' Computer skills (e .g. MS Excel, Word, PowerPoint) Kelly Scientific Resources® has grown into a $200 million global business as the scientific business unit of Kelly Services. Clinical Research is the clinical business unit of Kelly Services. Our staff of scientists provides scientific staffing to a broad spectrum of industries including: chemical, cosmetics, food science pharmaceutical, biomedical, consumer products, environmental, medical device, petrochemical, and clinical research. With more than 2,600 company-owned and operated offices in 30 countries, Kelly provides an incredible opportunity to job seekers all over the globe. We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyscientific.com. Kelly Services is an Equal Opportunity Employer.