Position:         Clinical Research Associate

Location:        Philadelphia, PA

Essential Duties and Responsibilities: 

·     Accountable for investigator site activities including, but not limited to, site selection, initiation, management and timelines, study drug delivery and management, specimen collection, and close-out activities.

·     Train investigator site personnel

·     Monitoring / co-monitoring as required

·     Interact with investigators and site staff

·     Assure trial and investigator site compliance with federal regulations, protocol requirements, ICH/GCP practices and investigator integrity

·     Identify areas requiring follow-up and improvement at investigator sites

·     Retrieve and review regulatory documentation

·     Manage SAE reporting procedures

·     Maintain orderly and accurate files on clinical investigators and sites

·     Responsible for managing investigator site and vendor budget activities

·     Track investigator payments

·     Define, negotiate, and ensure execution of study-related agreements such as clinical trial agreements, CROs, laboratory services, etc

·     Provide periodic internal reports, as requested, regarding study activities

·     Assist in the development of protocols, informed consents, case report forms, source notes and clinical reports

·     Assist with the development and resolution of data queries

·     Review of clinical trial data

·     Organize and assist with investigator meetings

·     Contribute to projects that support wider organization goals

Requirements:

• RN or BS degree

• Minimum 2 years experience as a CRA

Position:          Quality Assurance Specialist II                                                       

Location:          New Brunswick, NJ

Job Description:

The person will be working in a QA team environment to accomplish the Regulatory /QA  objectives of the organization, monitor the performance of the quality system and interact with research, manufacturing and QC departments to assure cGMP compliance.

The person is familiar with cGMP requirements of the biopharmaceutical industry and will be working on a variety of tasks involving development compounds and commercial products

 Responsibilities: 

• Writing/reviewing/releasing cGMP required documents, such as SOPs, validation protocols, validation reports.

• Assess supplier performance, including raw material suppliers as well as manufacturing and testing contractors.
• Review and release raw materials, intermediates and finished drug products
• Investigate or review investigation reports for deviations
• Conduct cGMP training, organize training for employees and document completion.
• Conduct audits, perform trend analysis, annual product reviews and other assessments of quality performance internally as well as suppliers
• Review CAPAs and track them to completion

 Qualifications: 

• Bachelor degree in scientific discipline
• 2-5 yrs pharmaceutical experience

• Perform unit operations in the manufacture of blood derived alpha interferon and a synthetic RNA species. 
• Operations in the manufacture of the interferon include but are not limited to cell isolation and culture, solution formulation, sterile component preparation, cell harvesting, bulk liquid concentration, preparative chromatography and related operations. 
• Operations in the manufacture of the RNA include but are not limited to RNA synthesis, extraction, precipitation, diafiltration and freeze-drying. 
• Both processes require compliance to cGMPs.

• A minimum of 2 years experience in a cGMP manufacturing environment or a BS in life science, chemistry, or related field is required. 
• Experience in at least some of the operations listed above would be preferable.
• Experience with bio-hazardous materials and/or hazardous solvents is important.
• Must be willing to work in a team environment.