Clinical Research Associate
Proclinical has partnered with top tier Contract Research Organisation in search for an experienced and talented CRA. This organisation has all the tools and dedicates its resources to finding effective cures. If you're looking to contribute to the growth of medicine then this might be the role for you.
- 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.
- Document 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.
- Participate in investigator meetings as necessary. 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.
- Ensure trial close out and retrieval of trial materials.
- 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
- Previous experience as a clinical research monitor that provides the knowledge, skills, and abilities to perform the job
- Experience performing monitoring for all phases of study life cycle to include start-up, interim, and close out
- Excellent understanding and demonstrated application of GCPs and applicable SOPs
- Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
- Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.