Project Associate

Founded in 1996, PharmaNet provides a complete range of clinical development and consulting services to the pharmaceutical, biotechnology, and medical device industries. PharmaNet services include strategic planning, data management and biostatistical analysis, medical writing, site management, and regulatory affairs activities. With strategically placed offices and clinical research professionals throughout the world, PharmaNet offers expertise for regional and global product development programs.

We currently have an opportunity for a Project Associate I to join our team in our Blue Bell, PA office or our Princeton, NJ headquarters.

Job Functions:
·Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites
·Recruit investigators for clinical trials
·Negotiate study budgets with investigators
·Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites (approximately 25 % travel) for GCP compliance according to PharmaNet SOPs and/or client guidelines
·Develop site management plan in conjunction with field-base staff
·Review draft protocols for completeness and feasibility
·Develop Case Report Forms (CRF) for clinical trials
·Prepare and process Serious Adverse Event (SAE) reports
·Prepare project management reports
·Review and verify CRFs and other clinical data for completeness and accuracy; generate queries
·Resolve queries with study site personnel
·Review Tables and Listings generated from study data
·Assist in writing Clinical Study Reports, with supervision
REQUIREMENTS
Minimum Requirements:
·Bachelor’s Degree or RN
·Six months’ work experience in clinical research, data management, regulatory affairs or other relevant healthcare research position. In lieu of this work experience, those with an applicable doctoral degree (eg, PhD, PharmD, MD) will be considered
·Excellent written and verbal communication skills
·Ability and willingness to travel up to 25% of the time
·Excellent organizational skills
·Ability to manage time and work independently

PharmaNet offers a people and career-oriented environment, competitive salaries, and an excellent benefits package. Please forward resume and salary requirements to: [Click here for email]. Please visit us for more information at www.pharmanet.com.