Clinical Research Associate (CRA) - B

DivIHN (pronounced Divine) is a nationally-recognized Business Technology Solutions and Staffing services provider headquartered in Chicago. Since our formation in 2002, we have been trusted by Fortune 500 organizations to help them locate and hire best-in-class talent through our Award-winning Professional Workforce Solutions program.

Check out our careers page to see all of our job openings: http://divihn.com/careers/find-a-job/

One of our BEST F500 customers has engaged us to help them hire a Clinical Research Associate (CRA) - B to be available to work out of their office in Alameda, California; details can be found below.

6 months

Please apply or call one of us to learn more

For further inquiries regarding the following opportunity, please contact one of our Talent Specialists

Nandha at (220) 507-1184

Divya at (224) 369-2969

Title: Clinical Research Associate (CRA) - B

Duration: 6 Months

Location: Alameda, CA

Description

This position is NonExempt. Hours over 40 will be paid at Time and a Half.

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.

Must have a minimum of 2 years experience with "clinical research monitoring".

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.

Essential Duties-

Performing study site visits, monitoring study data, qualification visits, training visits, reviewing with managers and performing reviewing of clinical data, participating in the study of data, study documentation, data listing study, report to management, will perform escalations if needed.

Knowledge of ICH guidelines (plus), good clinical practice, federal regulations, and other regulations may be required in the study

They will be working on devices for clinical studies.

Top Skills

Monitoring experience, great attention to detail, organizational skills.

Experience with EDC (electronic data capture)(plus ) electronic trial master file is a plus, they will get training in those

Pharma and medical device candidates are plus

CRO monitoring experience is also fine

Interview process

1 round of interview with 3 people, (half hr of each)

For locals, in-person interview in the Alameda office

For non-locals, it would be a video interview.

Education: Minimum Associate degree (but prefer Bachelor's) and 2 years of Monitoring experience.

Challenges: Monitoring position and local to San Francisco Site.

Travel - Average 20 to 35 % depends on what is going on and could be anywhere in the United States.

About Us

DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.