Clinical Research Associate -(Contract) | BioNJ Talent Services

Clinical Research Associate -(Contract)

Contact Information
Contact Name: 
Amicus Therapeutics
Organization Name: 
Amicus Therapeutics
Position Location: 
Cranbury
Company Profile: 

Amicus Therapeutics (Nasdaq:FOLD) is a global, patient-centric biotechnology company focused on discovering, developing and delivering high-quality medicines for people living with rare metabolic diseases.

The cornerstone of the Amicus portfolio is GalafoldTM (migalastat). The lead biologics program in the Amicus pipeline is AT-GAA, an investigational therapy for Pompe disease. Amicus is committed to advancing and expanding a robust pipeline of cutting-edge, first- or best-in-class medicines for rare metabolic diseases.

Job Description:

SUMMARY OF POSITION

The Clinical Research Associate (CRA) is responsible for assisting the Clinical Operations team(s) in overseeing sites conduct of clinical studies through monitoring and efficiently and effectively communicating site related items to the study team.

ROLES AND RESPONSIBILITIES

The CRA is responsible for:
Be primary point of contact for sites
Build and maintain relationship with sites
Monitor sites (Initiation Visits, Routine Visits, Close Out Visits, etc)
Produce monitoring reports within SOP and monitoring plan timelines
Coach investigators to be compliant with GCPs and the protocol
Talk to site staff about site recruitment
Ensure sufficient drug supply on site and reconcile drug on site
Ensure high quality data and conduct at sites
Identify and escalate issues or concerns to the internal Amicus team
Identify, analyze problems and trends; provide and recommend solutions across studies
Acts as liaison between CRO CRAs, Sites and the CTM
Accountable for reviewing and approving all trips reports for assigned studies
Develop training tools and training materials in support for the project
Develop study tools for sites and CRA use
Ensure that monitoring visits are performed in accordance with protocol/SOP monitoring plan requirements and that these are tracked, including report status and sign off .
Accountable for the quality of the trip report content
Facilitate the review and provide input to the Monitoring Guidelines
Co-monitor with 3rd party CRAs as needed
Attend Investigator Meetings and other as needed
Reports to Clinical Trial Manager, Clinical Operations

Qualifications: 

Qualifications and Background Requirements
BS or BA required; Nursing Degree preferred
CCRP certified or agrees to become certified within 6 months of hire

Professional Work Experience
2+ years experience from similar work within a pharmaceutical company or CRO is preferable, but can also have experience as a research coordinator
Strong work ethic
Team player with a positive attitude
Excellent organizational skills
Excellent command of MS Powerpoint, Word, Excel and Project
Self-motivated and able to function with little supervision
Highly detail-oriented
Able to multi-task
Excellent interpersonal skills
Superior communication skills, both verbal and written
Able to resolve conflicts in a diplomatic manner
Solid problem-solving and decision-making skills

Note:
Currently hiring (3)

Additional Job or Internship Information
Position Type: 
Contract
Function: 
Clinical Research