Clinical Research Scientist

5 - 7 years experience  • 

Salary depends on experience
Posted on 03/21/18
Bridgewater, NJ
5 - 7 years experience
Salary depends on experience
Posted on 03/21/18

Job Description

SUMMARY:

The Clinical Research Scientist (CRS) will support and work predominately with the Medical Monitor for assigned protocols and/or projects, partnering with vendors and cross functional teams. The CRS will provide scientific support to clinical development and operations, regulatory and quality assurance teams, as well as overall program support ensuring the adherence to all standard operating procedures (SOPs).

RESPONSIBILITIES:

Participate in cross functional teams to develop and implement Clinical Study protocols within clinical program(s). Responsibilities include but are not limited to:

  • Collaborate with internal teams, CROs and external vendors to prepare, review and finalize clinical protocol documents
  • Contribute to scientific and operational aspects and stages of the protocol development and execution from study design planning through final reporting of result. 
  • Provide scientific input and review of protocol data, support in assessing medical monitoring reports, study integrity/conduct and protocol oversight
  • Support preparation of abstracts, manuscripts, presentations, and materials for meetings as it related to the protocol(s) and program 
  • Provide protocol level scientific review of information to support the development and updates for regulatory documents (i.e. IND submissions, IND Annual Updates, DSUR, Investigator Brochures, and briefing books) and aid in the development of responses to regulatory authorities when questions arise for the protocol
  • Support enrollment projections and assist with the development and implementation of subject recruitment and retention strategies

Provide scientific support to the study teams, including:

  • Collaborate with team members in the review and development of Data Management activities including development of eCRFs, edit checks, report development and database lock processes
  • Participate in activities related to review of data review, database lock, medical monitoring and query resolution for the protocol
  • Work with medical monitors and drug safety vendor(s) to provide support and scientific review of adverse events
  • Provide scientific review of statistical analysis plans

Support corporate objectives:

  • Development, review and revision of departmental and corporate SOPs and processes
  • Provide clinical development and technical expertise in support of due diligence activities
  • Support regulatory activities at the protocol level to develop, prepare and respond to regulatory authorities 

Qualifications

  • Requires a Bachelor's degree combined with a minimum of 5 years of relevant experience; a Pharm.D. or Ph.D is strongly preferred with a minimum 3 years of drug development experiencerequired
  • Knowledge of pharmacokinetic applications related to drug disposition 
  • Strong medical writing and presentation skills
  • Understanding of biostatistics and data management 
  • Ability to read, analyze and interpret common scientific and technical journals, financialreports and legal documents
  • Excellent written and oral communication skills
  • Ability to work in high paced working environment
  • Demonstrated team-building skills and the ability to work successfully in a matrix team environment.
  • Analytical, negotiation, meeting management, cross-functional team and leadership skills
  • Experience with EDC systems, experience with RAVE and J-Review preferred 
  • Skills in conflict management, time management and organizational
  • Travel requirement approximately 5-10% based on protocol development stage and program needs

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