CASY-MSCCN Jobs

Job Description SummaryThe In-House Clinical Research Associate (I-CRA) supports the day to day operations associated with the execution of clinical trials. The primary objective and purpose of this position is to ensure the overall quality of clinical trials by remote-review of study documentation and supporting the Clinical Project Manager and Clinical Research Associates.

The I-CRA is responsible for regulatory document collection, tracking screening and enrollment,

supporting safety reviews and reporting.

The I-CRA is responsible for quality control of all clinical trial documentation. The I-CRA will be assigned to support multiple clinical trial sites and studies. The I-CRA is expected to contribute to the development and improvement of company procedures, processes, and templates in support of Global Clinical Development efforts towards continuous quality improvement.

Job Description

An In-House CRA:

• Supports global business units with TMF ownership and accountability

• Builds new eTMF study, country and site binders; manages permission groups with direction from eTMF Business and Technical Owners

• Serves as a study eTMF Owner, Provides Level 1 support, completes QC review

• Assists in the preparation of study binders, manuals, or other site specific tools

• Provides monitoring visit support as a co-monitor as needed, and supports site qualification, site training, routine monitoring visits and close-out visits.

• Accounts for investigational devices ensuring the devices are available, stored appropriately, and accurately inventoried and documented

• Verifies appropriate reporting and documentation of adverse events and protocol deviations per internal and protocol requirements

• Ensures TMF and site regulatory binder are current and aligned

Requirements

Above all, we are looking for an I-CRA who fits best within our department with regards to personality, motivation and drive. In addition, our ideal candidate has:

• BS/BA in a related scientific area

• Basic knowledge of clinical trial methodology relating to the monitoring of clinical trials, GCP, FDA, and / or country specific regulatory environment

• Minimum of 1-3 years of clinical research experience

• Mastery of MS Office Suite of products

• Demonstrable problem solving skills

• Excellent interpersonal and communication skills

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Primary Work LocationUSA NJ - Franklin Lakes

Additional LocationsUSA RI - Warwick

Work Shift

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.