Overview We are seeking a Clinical Research Associate II in Bethesda, MD to support our National Institutes of Health, National Cancer Institute, and Center for Cancer Research customer. In this role, you will provide monitoring to the NCI/CCR intramural clinical trials.
Responsibilities What you'll do...
Study monitoring, which includes reviewing the conduct of clinical studies from site initiation to study closure.
Act as liaison between study site personnel and the sponsor; performing monitoring in the field; ensuring compliance with protocols, regulatory requirements, and good clinical practices; providing monitoring visit reports. In the instances where there is a clinical study protocol deviation, providing guidance to the study site regarding the root cause analysis, impact assessment and any corrective action or correction that is required.
Ensure the quality and compliance of the clinical study, which includes site inspections to verify materials and data integrity; assisting site personnel and performing ongoing follow-up with the research team and CCR project team.
Conduct sites coordination, review trial-related documents including but not limited to Informed Consent Forms (ICF), source documents, and Case Report Forms (CRFs)
Ensure quality of data generated from clinical sites and assist in resolving patient eligibility and protocol deviation issues
Serve as a liaison and resource for assigned investigational sites
Qualifications You'd be a great fit if...
You've spent 3+ years demonstrating proficiency in clinical trial conduct (general knowledge of clinical research protocols, working knowledge of regulatory in clinical research.
You've spent 3 or more years in a medical, clinical, or research related fields
You have a BS/BA or equivalent in a health-related field
Have strong knowledge in medical terminology
Available to travel (up to 20%) as needed
It'd be even better if you...
Have an MS or advanced degree in Medicine or Life Science and minimum 1 years of related experience
CCRP/ACRP certification is desirable
Have working knowledge of GCP/ICH and FDA regulation in clinical research
Experience in monitoring for different types of clinical trials, oncology preferred
Strong computer skills (Microsoft Word, Excel, Power Point, ADOBE)
Strong communication skills
What you'll get...
• An immediately-vested 401(K) with employer matching • Rapid PTO accrual schedule with floating holidays • Comprehensive medical, dental, and vision coverage • Tuition assistance, financing, and refinancing • Paid maternity and paternity leave • Company-paid infertility treatments • Cross-training and professional development opportunities • The ability to i nfluence major initiatives
About Peraton Are you ready to join the next-generation of national security? Peraton is a fresh name in the industry with an established portfolio and legacy going back more than a century. We work differently than our peers - with agility, the freedom to innovate, an entrepreneurial spirit and a culture of responsibility. As part of the Peraton team, you'll be part of our movement to build a great company, solve the most daunting challenges facing mankind today, to protect and promote freedom around the world, and to secure our future, for our families, our communities, our nation, and our way of life.
EEO Statement We are an Equal Opportunity/Affirmative Action Employer. We consider applicants without regard to race, color, religion, age, national origin, ancestry, ethnicity, gender, gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status, or membership in any other group protected by federal, state, or local law.