We are looking to recruit a talented CRA II, you will be expected to perform and coordinate all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations and PPD SOPs. This role is based in Paris.
- Contribute to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
- Maintain & complete administrative tasks such as expense reports and timesheets in a timely manner.
- Respond to company, client and federal regulatory requirements/audits.
- 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).
- 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. Perform trial close out and retrieval of trial materials.
- 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.
- Escalates observed deficiencies and issues to clinical management expeditiously, present potential 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. Conduct monitoring tasks in accordance with the approved monitoring plan
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 one year) or completion of PPD Drug Development Fellowship.
- Proven clinical monitoring skills
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Demonstrated ability to attain and maintain a working knowledge of GCPs and applicable SOPs
- Good 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
- 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.