- Travel to sites conducting clinical trials to ensure all activities are in compliance with the protocol, federal regulations and ICH-GCP (Good Clinical Practice) guidelines.
- Conduct the following monitoring visits:
- Oversee drug accountability, storage and disposition at investigative sites.
- Collect and maintain investigator regulatory documents.
- Conduct Site Endpoint Evaluation Visits when required by contract.
- Ensure proper maintenance of required records for monitoring activities and required regulatory documents per CPC requirements.
- Help produce study materials, including Case Report Forms, Study Procedure Manuals and source documents.
- Assist with the selection of qualified sites and investigators for participation in research protocols.
- Develop and present materials for investigator meetings and sponsor/CRO training.
- Provide training to other CRAs as well as to staff at selected research sites.
- Nursing or bachelor's degree preferred but not required.
- Minimum of three years of experience in clinical trials research.
- At least one year experience as a CRA.
- Demonstrated mastery of CRA I responsibilities.
- Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials.
- Understanding of the drug development process.
- Intermediate level of proficiency in MS Office.
- Experience with EDC and CTMS strongly preferred.
- Good interpersonal communication skills, good organizational skills and a great attention to detail.
- Ability to complete tasks in an accurate and timely manner with minimal supervision.
- Ability to discern priorities to accomplish day-to-day tasks.
- Ability to manage conflicts and resolve problems effectively.
- Ability and willingness to travel up to 60%.
- Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
- Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)
- 11 paid holidays
- vacation days based on years of service
- Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours)
- In-suite exercise and relaxation room
- Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)
- Flexible and remote work schedules
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Clinical Research Associate II - Aurora, United States - CPC Clinical Research
Description
Job Description
Job DescriptionSalary: $66,000 - $80,000We are looking for a Clinical Research Associate II to join our team
Do you have clinical research background? Are you someone who enjoys traveling and adapts to change easily? Can you quickly connect and build strong relationships with people? Can you proactively identify a problem and develop solutions? If you have answered yes, then keep reading
In this position you will:
Site Evaluation Visits
Site Initiation Visits
Routine Monitoring Visits
Close-out Visits
Here's what you will need to bring to the table:
Note: Viable applicants will be required to pass a background and education verification check.
Targeted Compensation: $66,000 – $80,000 annually
Deadline to Apply: June 1, 2024
About CPC:
CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 30 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more.
CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials.
CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy.
CPC offers:
An Equal Opportunity Employer
CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.
Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at
remote work
