Sr. CRA, In-house / Drug Safety

Our client, a leader in the pharmaceutical research industry, has several longterm contract opportunities open for experienced Clinical Research Associates and Drug Safety professionals. Both positions require individuals who possess a strong attention to detail, excellent focus and dedication to the critical role they play in the clinical trial process. Candidates are required to have at least 3-5 years of related experience and have obtained a Bachelors degree.

 

Position descriptions are as follows:

Title

Sr.CRA, In-house

Responsibilities include:

Conducting Phase I - IV studies according to Federal Regulations and ICH guidelines and study protocol

Planning study conduct

Writing study protocols

Designing CRF's

CRO selection, training and mangement

Selection and training of study investigators

Planning and running study meetings

Overseeing the evaluation, selection and training of new study investigators

Initial budget and contract negotiations with study sites or CRO's

Writing and supervision of contributors of clinical reports and NDA documents, including integrated Summaries of Safety and Efficacy (ISS and ISE), as appropriate

Title

Drug Safety

We are seeking RN/BSN candidates who have extensive pharmacovigilence experience and extensive SAE review and follow up.

Responsibilities include:

Medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings.

May manage the activities of regional contract CRAs, and organizes the files and budgets associated with several clinical studies.

Provides medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA

Medical Communication which includes writing standard and custom responses to communication requests

In-depth assistance to the medical and lay community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database.

May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification

 

ASG, Inc. is a nationwide contract consulting and contingency recruiting firm. Our reputation for excellent service, our knowledge of the market place, and our success in the recruiting industry make it possible for us to provide complete and comprehensive contract consulting and contingency technical services.  Align yourself with ASG and get: challenging assignments and competitive compensation (with or without benefits).  Our job is to keep you focused on your work and to provide you with a comfortable working relationship with us, your business partner, ASG.

 

If you would like to be considered for this position, please forward your resume to andrew.adams@asg-inc.com please reference the job title and number.