Scope International is a full-service Contract Research Organization (CRO) offering a complete range of clinical development and consulting services to the pharmaceutical, biotechnology, and medical device industries.
We have an exciting office-based opportunity for a Project Management Associate (PMA) to join us in our US location in the Pittsburgh, PA. We specifically target candidates who wants to grow into the demanding role of Project Manager over time. This is an excellent opportunity for a site coordinator interested in moving to industry or a person with a PhD who wishes to jump from the lab to industry. We also welcome experienced PMAs from the clinical research industry to apply.
The PMA has a key role in the success of clinical trials. You will the assist the Project Manager (PM) with all day to day tasks of conducting a clinical research study.
Attends investigator’s and project team meetings as well as sponsor meetings/teleconferences.
Supports the identification of potential clinical trial sites.
Provides support to ensure that all relevant documents are submitted to the CAs and EC/IRBs involved and reporting is done throughout a project according to applicable regulatory requirements.
Supports the project manager in the supervision for project-specific procedures as outlined in the operations manual to be followed by the CRAs.
Assists with the set-up or documents required for investigator site files (ISF).
Supports the project manager with the preparation, conduct and follow-up of project-specific training of the project team.
Supports the development and management of project-specific essential and supportive documents including preparation, tracking, documented quality control (review for correctness, completeness and adequacy), maintenance and final disposition in the TMF. Helps to ensure that relevant essential documents are translated, if required.
Support the project manager with status tracking for updates to sponsor and internal needs.
Assists the project manager with the formal review of visit reports prepared by the CRAs.
Assists the project manager with the communication within the project team, sponsor and vendors.
Supports the project manager in the supervision of monitoring frequency, visits to non-recruiting sites, percentage of SDV, recruitment status, data cleaning process and query status.
Supports the project manager to keep the protocol deviation tracking up-to-date and to provide the list of protocol deviations to the medical monitor on a regular basis.
Adheres to SOPs, ICH-GCP guidelines and applicable (local) regulatory requirements.
Assumes roles outside of job description when necessary to meet company timelines.
Scientific PhD or at least 2 years of experience as a study coordinator of industry-sponsored, FDA regulated research 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 approximately 20%, depending on project needs.
Knowledge of ICH-GCP guidelines and applicable regulations a strong plus.
Excellent organization, customer service and communication skills.
Excel skills preferred.
Internal Number: 02
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.