Scientist-I

List major responsibilities and duties of the position. List most complex or difficult parts of job first. Describe scope of responsibilities.

• Assist with activities as assigned by the the Clinical Scientist or Study Responsible Physician which support the monitoring and reporting of clinical trials .

• Member of the clinical Work Group (WG) for each study assigned.

• Assist with study-specific data review activities in support of database locks.

• Support monthly medical monitoring data review activities.

• Assist with tracking of safety events, review of new SAEs, and Narrative as appropriate.

• Assist/Coordinate activities in support of external data requests

• Other activities as determined by study team and phase of trial (ie start-up, execution or close out).

PRINCIPAL RELATIONSHIPS: 

• Describe the primary working relationships (internal & external) and primary interfaces.

• Clinical Team: SRP/SRSs, Clinical Scientist, MRP, GI-Derm/Immunology VP

• Contacts Inside the Company: Integrated Data Services, Global Medical Safety, Global Clinical Operations, programming & biostatistics

• Contacts Outside the Company: vendor and CRO/ARO contacts as appropriate

• Internal J&J Use Only Revision Date: April 27, 2016

• Supervision: This position reports to Clinical Scientist/SRP

EDUCATION AND EXPERIENCE REQUIREMENTS: 

• Describe the minimum knowledge, skill and ability requirements for the position. Include any degrees or certifications which are required and/or desirable.

• Bachelor’s degree (or equivalent) required and 1-2 years relevant work experience preferred.

• Bachelor’s degree in a scientific displine or nursing preferred. Candidates with additional degrees such as Masters (or equivalent) will also be considered but not required.

• Good organization skills, good written and verbal communication skills

• Excellent independent time management skills

• Proven ability to plan and track deliverables and timelines

• Individual must work well in a dynamic environment and be able to prioritize and respond to changing needs of the business.

• Proficient Microsoft Office applications and use of Internet, EXCEL, POWERPOINT, WORD

For more information, Please contact

Sneha Shrivastava

973-967-3348