Clinical Trial Transparency Senior Associate

IntegratedResourcesINC

Cambridge, MA, United States permanent

Posted: September 16, 2016

Quick Summary

We are seeking a Clinical Trial Transparency Senior Associate to join our team in Cambridge, MA. The ideal candidate will have experience in clinical trials and a strong understanding of regulatory compliance. The successful candidate will be responsible for ensuring the accuracy and integrity of clinical trial data.

Job Description

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Title: Clinical Trial Transparency Senior Associate

Location: Cambridge, MA
Duration: 7+ months (Possibility of extension)

Job Description:
• Performs the Clinical Trial Registration and/or results disclosure activities for new and/or ongoing studies.
• Ensures compliance due dates are defined and timelines are met.
• Collaborates with the Study Team to complete the data entry in support of Clinical Trial Disclosure, utilizing information from source documents and systems (e.g. protocol, CTMS).
• Assigns tasks, initiates workflows, follows up on all action required, and escalates alerts when needed in order to maintain content that has been made public (e.g. clinicaltrials.gov).
• Shares accurate information with various functional leads to be utilized throughout global disclosures
• Performs internal quality control review of disclosure information.
• Participates in User-Acceptance Testing (UAT) of disclosure system.
• Supports process analysis efforts by identifying opportunities to improve the efficiency and effectiveness of the Clinical Trial Disclosure process.
• Generates metrics for disclosure activities.
• Supports the development and delivery of training materials.

Requirements:
• Firm understanding of Clinical Development and operations.
• Previous experience (2-3 years minimum) in pharma/biotech industry.
• Must have previous experience disclosing clinical trial information on ClinicalTrials.gov.
• Minimum education of Bachelor Degree (or equivalent experience).
• Experience with PharmaCM would be a plus.

We do have referral bonus of $500 per candidate, if you refer any of your friends or colleague who are looking out for the same job.

Thanks & Regards,

Seema Chawhan
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I

DIRECT # - 732-844-8724|

LinkedIn: https://in.linkedin.com/in/seemachawhan
Gold Seal JCAHO Certified ™ for Health Care Staffing
“INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)

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