SENIOR CRA / CRA III
Proclinical is currently recruiting for a Senior CRA/CRA III for a pharmaceutical company located in Seattle, WA. Successful candidate will be responsible for the day-to-day operations of designated clinical trials including CRO management, investigator selection, participate in the preparation and/or review of trial related documentation and interact with senior management to maintain corporate timelines for the completion/success of study projects.
- Assist the CTM in the departmental support for the oversight of operational aspects of assigned clinical trials as needed.
- Attend assigned project meetings such as bid defenses, Kick off meetings, planning meetings, Investigator Meetings, teleconferences, etc.
- Per CTM, manage aspects of the Contract Research Organization to ensure project success.
- Manage the identified vendors for a particular study when needed. Track and review associated invoices.
- Organize/participate in investigator identification and/or selection.
- Organize and perform co-monitoring of identified sites during Site Qualification Visits, Site Initiation Visits, Interim monitoring visits and close-out visits for the assigned clinical trial following company SOPs and in accordance with GCP and FDA guidelines.
- At site co-monitoring visits, identify potential issues and assist in the resolution of study and/or site issues.
- Provide in-house training to team CRAs for project specific training as necessary.
- Track completed CRFs/eCRFs (and set up systems whereby completed CRFs are rapidly entered into the database if applicable).
- Assist Data Management to ensure that queries generated during cleaning are responded to in a timely fashion either through communication with the CRO/CRA or directly with the site.
- Complete sponsors review of monitoring reports and follow up letters and provide feedback to the CRO.
- Periodic review of data quality and identify potential errors and/or issues and report to in-house management and CRO.
- Review all SAEs, IREs or UAEs and provide input to Safety when necessary
- Travel to CRO/vendor facilities (and/or investigative sites to train and assess study team and CRAs) or participate in QA audits as needed.
- Participate in departmental planning sessions, SOP development and other projects as assigned.
- Meet and report weekly with all the Clinical Operations personnel directly involved with each project to report progress, issues and status.
- Act as mentor to other team members. Develop and deliver training as needed.
Skills and Requirements:
- BA or BS required, preferably in Nursing (RN or BSN), Life Sciences (BS or BA), Pharmacy or related field.
- 5+ years' experience in clinical operations. Prefer experience in a drug development setting.
- International clinical trials experience a plus.
- Monitoring experience, 5+ years' field experience with SQVs, SIVs, IMVs and COV required.
- Knowledge of FDA regulatory requirements and ICH/GCP guidelines essential.
- Demonstrated understanding and good use of judgment in application of regulations to clinical trial implementation and conduct.
- Demonstrated collaboration and communications skills.
- Computer proficiency (Microsoft Office, Outlook, use of databases)
- Fundamental knowledge in Clinical Research, an expert in all phases of a clinical trial.
- Ability to use initiative; prefer some supervisory or training experience.
- Able to travel up to 30% of the time (international and domestic).
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nicole Aganon at (+1) 347-293-1161 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.