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Senior Clinical Research Associate
Pacific Edge Hummelstown, PA
$66k-87k (estimate)
Full Time | Restaurants & Catering Services 1 Day Ago
Save

Pacific Edge is Hiring a Remote Senior Clinical Research Associate

Pacific Edge Cancer Diagnostics Company
Our People: Our strength is in our people. We believe hard working, dedicated people make a significant difference.
Our Goal: To deliver actionable results that can contribute to a clinically meaningful difference in cancer treatment.
Our Focus: The development of state-of-the art diagnostics and prognostics
Our Motivation: To meet and exceed expectations; never stand still and or accept second best.
The Senior Clinical Research Associate position is responsible for monitoring administration (such as scheduling, and preparing for, Monitoring visits), as well as site and study management (to include documentation maintenance and tracking.) Although this is a Remote/Telecommute position, approximately 75-80% of the role will entail traveling for national site visits, as well as overnight travel 2-3 days at a time. 
Key Responsibilities
  • Scheduling, preparing reports related to, and closing out Monitoring visits
  • Preparing and maintaining study documents, site level enrollment plans, and Action Items
  • Developing training presentations, and conducting Site Initiation Visit (SIV)and training
  • Collecting documentation from new study team members; conducting documentation maintenance and tracking and resolve issues with site documentation
  • Review Protocol Deviation (PD) log entries and contribute to adjudication meetings
  • Track, as needed, lab kit status and delivery.
  • Prepare for, and contribute to, meetings as required, to include study update meetings, clinical team meetings, data management meetings, and adjudication meetings.
  • Contribute to FAQ maintenance, newsletters, and protocols and other amendments.
Qualifications and Experience
  • Bachelor's Degree in Life Sciences from an accredited institution
  • At least 10 years’ experience 
  • Knowledge of, and ability to use, Microsoft Excel
  • GCP (within same year of certification required), GDP, regulatory and FDA knowledge a must
  • Site management experience preferred, to ensure a safe and commercially sound professional practice.
  • Meet professional requirements by working within a professional value base and conforming to agreed codes of professional practice.
Physical EnvironmentFunctions in a temperature-controlled office environment some of the time, but approximately 75-80% of the time in the role entails travel for site visits. (Visits are scheduled nationally and may require 2-3 days at a time; overnight hotel stays are required.) Work requires the ability to sit and stand (whether in an office or site visits), and drive, throughout an extended workday (8-10 hours); position requires use of fingers, hands and arms on a consistent basis for keyboarding and phone work; position requires the ability to talk and hear; position may need to lift up to 30 pounds on occasion; good vision skills (with or without correction) are required. The standard site visits entails moderate noise levels associated with computer equipment, customers, and phone conversations. Significant travel required.Pacific Edge Diagnostics USA is an Equal Opportunity Employer - all are encouraged to apply!

Job Summary

JOB TYPE

Full Time

INDUSTRY

Restaurants & Catering Services

SALARY

$66k-87k (estimate)

POST DATE

03/27/2024

EXPIRATION DATE

06/23/2024

HEADQUARTERS

CARMEL, CA

SIZE

<25

FOUNDED

2005

CEO

NORBERT RELECKER

REVENUE

<$5M

INDUSTRY

Restaurants & Catering Services

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