This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.
Summary:
Under supervision of Clinical Lead, performs monitoring and site management activities to assess the progress of clinical studies at assigned investigative sites (either on site or remotely). The CRA will ensure all site activities are conducted in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and applicable regulations.
Responsibilities include:
a. Performs site initiation visits
b. Performs interim & close out monitoring visits
c. Verifies required clinical data entered in the electronic case report form (eCRF) is accurate and complete
d. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
e. Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF).
f. Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
g. Documents activities via confirmation letters, follow-up letters, trip reports
h. Site support throughout the study lifecycle from site identification through close-out
i. Attends and participates in internal meetings
Qualifications:
a. BS/BA
b. Minimum of 2 years of site management and field monitoring experience
c. Knowledge of applicable standards and regulations for clinical trials
d. Proven oral and written communication skills
e. Proven planning skills; ability to create and track detailed project plans
f. Proven interpersonal, leadership, organizational and effective time management skills
g. Demonstrated experience in computer skills to include Microsoft Word, Excel and basic templates
h. Ability to work independently and within a cross-functional team environment to identify and escalate site/monitoring related activities issues to the management team in a timely fashion
Preferred:
a. Experience in cancer studies
b. IVD Study Experience
c. Medidata RAVE system
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Many Thanks,
Sree Kanth
Recruitment Manager
Sree@newageclinical.com
NewAgeSys, Inc.
Direct: 609-945-1736 Fax: 609-228-4079
4390 US-1, Suite 110
Princeton, NJ 08540
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