Clinical Research Associate/entry level Job in Pittsburgh 15206, Pennsylvania US
We are still growing strong.
For over 25 years, Novum Pharmaceutical Research Services has been a world leader in the conduct of clinical trials and equivalency studies for the generic, pharmaceutical, and biotechnology industries.
Last year alone the FDA approved over 40 products for marketing where Novum had designed, conducted and reported the studies in the marketing application. We have completed over 2,000 studies with over 36,000 participants for more than 200 pharmaceutical companies.
Clinical Research Associate/entry level
Description
Are you a new grad looking to take the first step in your clinical research career? Do you love to travel? The program begins in early June so act now.
Novum Pharmaceutical Research Services is a specialist Contract Research Organization that offers study services to the generic, pharmaceutical, biotechnology industries and other Clinical Research Organizations.
We currently have openings for dynamic new grads to join our team in Las Vegas, NV or Pittsburgh, PA. No experience necessary. We will train you in our world famous, paid Clinical Research Training Program to become a Clinical Research Associate. As a CRA, you will be responsible for monitoring multi-site assignments for Phase II-IV clinical trials, including adherence to Good Clinical Practices, investigator integrity and compliance with protocol and study procedures, at investigator sites, in accordance with Novum SOPs.
Duties include:
- Review Regulatory Documents from Investigator Sites for completeness and accuracy. Coordinate IRB submission for Investigator Sites.
- Maintain master study file.
- Assist in the development of protocols, consent forms, CRFs and source document templates as necessary.
- Conduct site selection, initiation, close out and interim monitoring visits at assigned investigator sites.
- Review study site data to ensure compliance with the study protocol.
- Verify CRFs with source documentation.
- Track SAEs reporting at Investigator Sites.
- Meet with Sponsor representatives as requested.
- Develop template study advertising materials to be used by investigator sites as needed.
- Coordinate study drug shipment to investigator sites with the pharmacy.
- Review site’s regulatory binder to ensure that the master study files contain the most up to date information.
- Review site’s drug accountability logs per patients and overall.
- Monitor informed consents signed by study patients to ensure that the patients were consented properly and with the current revision.
- Enter site data into clinical trial database as necessary.
- Work with sites to resolve queries in a timely manner to ensure meeting the deadline for database lock.