What are the responsibilities and job description for the Clinical Research Associate position at APR Consulting?
APR Consulting, Inc. has been engaged to identify an Clinical Research Associate
Location: Boston, MA 02110
Position: Clinical Research Associate
Duration: 6 months, with opportunity of extension and potential for conversion
Pay Rate: $70-75/hr DOE
Expected Shift: 8AM-5PM, 40 hrs/week
Job Summary
Location: Onsite; position requires heavy travel to site locations in Minnesota, New Jersey and Illinois. Contractor will be expected to travel to multiple locations within a 6-8 week time frame. Estimated travel to 1-2 sites per week during the identified time frame. Willing to accept candidates residing anywhere in the US, as long as they can meet the travel expectations and work EST hours to attend daily staff meetings. Contractors are able to work in a remote capacity when onsite at research facilities.
Travel items will be reimbursed.
Job Requirements
– Must have experience working in clinical trials at CROs , site management experience. Contractor will be expected to take on role as primary contact at site locations and aid with day to day issue resolution
– Must have 3 years' experience as a CRA from a CRO background
– Minimum 3 years prior monitoring experience with global trials
– Minimum 2 years' experience with direct interim monitoring experience including SDV (Source Document Verification), SDR (Source Data Review) and MRR (Medical Record Review) with respect to eligibility (in/ex) criteria. and preferably in a remote environment
– Must have an In-depth knowledge of FDA regulations and ICH/GCP guidelines
– CCRA or SOCRA certified – highly preferred
– Must be familiar and adept with managing fully decentralized studies
Responsibilities
Ability to prioritize workload and manage multiple protocols
Contribute to the identification of new sites for clinical trials
Implement complete site management including monitoring visits and regulatory assessment
Resolve technical and content issues to achieve timely database lock targets
Negotiate investigator remuneration and prepare financial contracts
Implement site close-out activities and generate site close-out report
Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
Responsible for medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;
Our client is the one of the largest Healthcare Staffing Provider in the United States, to be assigned at one of their affiliated hospitals/healthcare facilities.
This particular client is requiring that all new hires show proof of vaccination. However, accommodations may be made for those with disabilities or religious reasons who cannot obtain a vaccine.
Since 1980 APR Consulting, Inc. has provided professional recruiting and contingent workforce solutions to a diverse mix of clients, industries, and skill sets nationwide.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Don't miss out on this amazing opportunity! If you feel your experience is a match for this position please apply today and join our team. We look forward to working with you!
The post Clinical Research Associate first appeared on APR Consulting.
Location: Boston, MA 02110
Position: Clinical Research Associate
Duration: 6 months, with opportunity of extension and potential for conversion
Pay Rate: $70-75/hr DOE
Expected Shift: 8AM-5PM, 40 hrs/week
Job Summary
Location: Onsite; position requires heavy travel to site locations in Minnesota, New Jersey and Illinois. Contractor will be expected to travel to multiple locations within a 6-8 week time frame. Estimated travel to 1-2 sites per week during the identified time frame. Willing to accept candidates residing anywhere in the US, as long as they can meet the travel expectations and work EST hours to attend daily staff meetings. Contractors are able to work in a remote capacity when onsite at research facilities.
Travel items will be reimbursed.
Job Requirements
– Must have experience working in clinical trials at CROs , site management experience. Contractor will be expected to take on role as primary contact at site locations and aid with day to day issue resolution
– Must have 3 years' experience as a CRA from a CRO background
– Minimum 3 years prior monitoring experience with global trials
– Minimum 2 years' experience with direct interim monitoring experience including SDV (Source Document Verification), SDR (Source Data Review) and MRR (Medical Record Review) with respect to eligibility (in/ex) criteria. and preferably in a remote environment
– Must have an In-depth knowledge of FDA regulations and ICH/GCP guidelines
– CCRA or SOCRA certified – highly preferred
– Must be familiar and adept with managing fully decentralized studies
Responsibilities
Ability to prioritize workload and manage multiple protocols
Contribute to the identification of new sites for clinical trials
Implement complete site management including monitoring visits and regulatory assessment
Resolve technical and content issues to achieve timely database lock targets
Negotiate investigator remuneration and prepare financial contracts
Implement site close-out activities and generate site close-out report
Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
Responsible for medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;
Our client is the one of the largest Healthcare Staffing Provider in the United States, to be assigned at one of their affiliated hospitals/healthcare facilities.
This particular client is requiring that all new hires show proof of vaccination. However, accommodations may be made for those with disabilities or religious reasons who cannot obtain a vaccine.
Since 1980 APR Consulting, Inc. has provided professional recruiting and contingent workforce solutions to a diverse mix of clients, industries, and skill sets nationwide.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Don't miss out on this amazing opportunity! If you feel your experience is a match for this position please apply today and join our team. We look forward to working with you!
The post Clinical Research Associate first appeared on APR Consulting.
Salary : $70 - $75
