Senior Clinical Research Associate
Proclinical have partnered exclusively with a growing pharmaceutical company who are looking for an experienced Senior Clinical Research Associate to join their team. The company have recently initiated a trial and are in need of an experienced individual to work closely with the project team.
You will be responsible for monitoring sites across Switzerland. You will also oversee, perform and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations and PPD SOPs.
- Monitors investigator sites to ensure the accuracy and validity of CRF entries in relation to patient records/clinic notes (source document verification).
- Assess investigational product through physical inventory and records review.
- Documents observations in reports and letters in a timely manner using approved business writing standards.
- Escalate observed deficiencies and issues to clinical management expeditiously, propose solutions and follow all issues through to resolution.
- Maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
- Conducts monitoring tasks in accordance with the approved monitoring plan.
- Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
- Ensure study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS).
- Perform QC check of reports generated from CTMS system where required.
- Bachelor's degree in a science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institution.
- In some cases an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills and Abilities may be considered.
- Previous experience as a clinical research monitor that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years) that provides the required knowledge, skills and abilities
- Experience performing monitoring for all phases of study life cycle to include start-up, interim, and close out
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.