Senior Clinical Research Associate
An exciting opportunity has arisen for a Senior Clinical Research Associate in Ireland. You will be expected to perform site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects
- 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.
- Identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
- Initiate clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
- Contribute to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
- Perform additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc).
Skills and Requirements
- 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.
- Valid Driver's License where applicable
- 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
- Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
- Good English language and grammar skills
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.