Senior Clinical Research Associate
ProClinical are currently recruiting for a Senior Clinical Research Associate in Cambridge with the chance to work from home. This a great opportunity to join a global research organisation with experience in over 100 countries.
- 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
- 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.
Skills and Requirements
- 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
- Customer focus
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.