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Clinical Trials Management Associate II

Job Description

19-09566 / Clinical Trials Management Associate II
Location: Foster City, CA
Industry: Biotechnology/Pharma
Position Type: Initial 6 Month Contract (full-time hours, W2)

Estimated pay rate: $40-$50/hr DOE!

For immediate consideration, please scroll down to the bottom of application for contact information and more!

Job Overview:
  • Must meet all requirements for Clinical Trials Management Associate position and have demonstrated proficiency in all relevant areas.
  • With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required.
  • Assures site compliance with the routine protocol and regulatory requirements and quality of data.
  • Assists in the setting and updating of study timelines.
  • Assists in CRO or vendor selection. With guidance from supervisor coordinates CROs or vendors.
  • Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans.
  • Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
  • Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams.
  • May participate in abstract presentations, oral presentations and manuscript development.
  • Interfaces with individuals in other functional areas to address routine study issues.
  • May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants.
  • Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives.
Education/Qualifications:
  • Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
  • Excellent verbal, written, interpersonal and presentation skills are required.
  • Working knowledge and experience with Word, PowerPoint and Excel.
  • Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
  • Ability to develop tools and processes that increase measured efficiencies of the project.
  • Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.
  • Must have a general understanding of functional issues and routine project goals from an organizational perspective
*Those authorized to work in the U.S. are encouraged to apply / Unable to Process H1B visa at this time / Unable to work on a C2C basis for this role* 

Serious candidates, please answer the following questions  after applying.  Please email directly to: bgalley@ascentsg.com 
1. Briefly explain your experience with  FDA regulations, EMEA Regulations, ICH Guidelines, and/or GCPs. 
2. List your experience within Clinical Trials and when/where  you gained that experience. 
3. How familiar you are with the commute to Foster City, CA. Note: if you are nonlocal please explain your connection to Foster City and why you are specifically looking at the Bay Area.  

Job Requirements

 

Job Snapshot

Location US-CA-Foster City
Employment Type Contractor
Pay Type Hour
Pay Rate $40.00 - $50.00 /Hour
Store Type Clinical & Scientific, Other
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Company Overview

Ascent

The Ascent Services Group (ASG) is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. ASG’s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Learn More

Contact Information

US-CA-Foster City
Bonnie Galley
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Snapshot
Ascent
Company:
US-CA-Foster City
Location:
Contractor
Employment Type:
Hour
Pay Type:
$40.00 - $50.00 /Hour
Pay Rate:
Clinical & Scientific, Other
Store Type:

Job Description

19-09566 / Clinical Trials Management Associate II
Location: Foster City, CA
Industry: Biotechnology/Pharma
Position Type: Initial 6 Month Contract (full-time hours, W2)

Estimated pay rate: $40-$50/hr DOE!

For immediate consideration, please scroll down to the bottom of application for contact information and more!

Job Overview:
  • Must meet all requirements for Clinical Trials Management Associate position and have demonstrated proficiency in all relevant areas.
  • With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required.
  • Assures site compliance with the routine protocol and regulatory requirements and quality of data.
  • Assists in the setting and updating of study timelines.
  • Assists in CRO or vendor selection. With guidance from supervisor coordinates CROs or vendors.
  • Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans.
  • Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
  • Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams.
  • May participate in abstract presentations, oral presentations and manuscript development.
  • Interfaces with individuals in other functional areas to address routine study issues.
  • May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants.
  • Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives.
Education/Qualifications:
  • Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
  • Excellent verbal, written, interpersonal and presentation skills are required.
  • Working knowledge and experience with Word, PowerPoint and Excel.
  • Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
  • Ability to develop tools and processes that increase measured efficiencies of the project.
  • Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.
  • Must have a general understanding of functional issues and routine project goals from an organizational perspective
*Those authorized to work in the U.S. are encouraged to apply / Unable to Process H1B visa at this time / Unable to work on a C2C basis for this role* 

Serious candidates, please answer the following questions  after applying.  Please email directly to: bgalley@ascentsg.com 
1. Briefly explain your experience with  FDA regulations, EMEA Regulations, ICH Guidelines, and/or GCPs. 
2. List your experience within Clinical Trials and when/where  you gained that experience. 
3. How familiar you are with the commute to Foster City, CA. Note: if you are nonlocal please explain your connection to Foster City and why you are specifically looking at the Bay Area.  

Job Requirements

 
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Clinical Trials Management Associate II Apply now