SCOPE International USA has exciting opportunities for experienced Clinical Research Associates (CRAs) to join our growing US team. We seek candidates from the east coast, mid-west and western US regions who want to work for a mid-size growing CRO that values its people and takes pride in delivering excellent services to our clients.
As a Clinical Research Associate (CRA) at SCOPE, you will have a key role in the success of clinical trials. You will be the primary contact and support for trial sites, ensuring that the study is conducted according to the protocol, ICH-GCP, regulatory requirements and standard operating procedures (SOPs).
Perform clinical trial site evaluation, initiation, routine monitoring and close out visits.
Review and ensure Investigator Site Files (ISFs) are up to date and collect essential documents for the Trial Master File (TMF)
Ensure proper handling, accountability and reconciliation of all Investigational Product(s) and clinical trial supplies
Prepare and submit trip reports according to project timelines.
Oversee and support sites with subject recruitment and retention strategies
Interact directly with sites, including clinical investigators and other health care professionals involved in the clinical trial to maintain a positive rapport and ensure project expectations are met.
Serve as a mentor to junior CRAs, occasionally perform on-site training and co-monitoring visits as needed.
Bachelors degree, preferably in a life science or healthcare related field.
Minimum 1-2 years of on-site monitoring experience required
Preference for candidates with experience in Women’s Health, Pain, or CNS but all therapeutic indications will be considered.
Ability and willingness to travel up to 80%, depending on project needs.
Good knowledge of ICH-GCP guidelines and applicable regulations.
Excellent organization, customer service and communication skills.
Internal Number: 01
About Scope International USA
SCOPE International USA is a full-service Contract Research Organization (CRO) that relies on flexibility, ingenuity, and collaboration to meet the goals and demands of our pharmaceutical, biotechnology and medical device partners. Based in Pittsburgh, Pennsylvania, our office is ideally situated in an emerging technology and biomedical hub amid renowned universities. This environment provides innovative industry opportunities and feeds our life sciences companies with bright young minds.
SCOPE International’s 17 offices in the US and Europe enable the SCOPE team to directly cover North America and over 30 European countries. Additionally, SCOPE is supported by long established development partners in other geographic areas. SCOPE has performed over 250 clinical trials which enrolled over 65,000 subjects. Our clinical development services span a wide range of therapeutic areas with a focus in women’s health, respiratory disorders, CNS and pain indications, immunology and hematology/oncology.
SCOPE International USA takes great pride in our culture that emphasizes the value of trusted long-term relationships. At the core, SCOPE is a “people” company: SCOPE’s “people” work t...o serve our clients’ “people”, who ultimately help and improve the lives of “people” around the globe.