job summary: Clinical Research Associate I (CRA I)
location: Lexington, Massachusetts
job type: Contract
salary: $41.73 - 49.09 per hour
work hours: 9 to 5
education: High School
responsibilities: Job Responsibilities
- Oversee conduct of assigned clinical studies including acting as liaison to clinical investigators, ensuring the quality and integrity of data.
- Prepare and conduct study initiation, closeout and monitoring visits at clinical investigative sites to ensure adherence to procedures, protocols and project plans in accordance with FDA regulations.
- Maintain site files, trial master files and study documentation.
- Develop status reports, SOP revisions and document quality control.
- Review and process regulatory documentation, ensure the execution of clinical trials in a timely, efficient manner, working within established timelines and budgets.
- Track clinical trial supplies, patient recruitment activities, and Serious Adverse Events, review Case Report Forms for accuracy and completeness and conduct query resolution.
- Identify investigator sites for participation in trials and organize investigator meetings.
qualifications: Education & Qualifications
- Experience working in clinical research as an In-house Clinical Research Associate, Clinical Research Coordinator, or Regulatory Affairs position.
- 0-2 yrs of experience monitoring clinical research studies as a Clinical Research Associate and experience managing multiple studies at various locations - regionally or nationally.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
skills: CRF, FDA, COV (Close-Out Visit), PSV (Pre-Study Visit), RMV (Routine Monitoring Visit), SIV (Site Initiation Visit), SAE (Serious Adverse Event), TMF
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.