Clinical Research Associate (based anywhere in the UK)) (closed)
We are looking for an experienced CRA, particularly in Scotland ,North West and South West but anywhere in the UK is of interest to us.Candidates will need either extensive experience in monitoring Phase I or III studies in Oncology, or complex Secondary Care monitoring experience.
The candidates is responsible for monitoring all types of clinical trials, assuring adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures.
1. Communication* Maintains timely and effective communication among team members and site staff.* Keeps project leadership apprised of team issues, seeking guidance as needed.* Participates in Business Development client presentations and bid defenses as requested.
2. Regulatory Documentation* Assures compliance with CFR, State regulations, ICH and GCP guidelines.* Maintains current regulatory documentation according to Essential Regulatory Document Guidelines (ERDG) and Trial Master File (TMF) Plan.* Participates in TMF and on-site audits as requested.
3. Monitoring* Assumes responsibility for site management and site staff performance including:* Monitors all types of clinical trials.* Participates in all types of site visits.* Assures Principal Investigator (PI) integrity.* Assures compliance with all protocol requirements.* Assures effective patient identification and recruitment plan is in place.* Assures timely reporting of AEs/ SAEs and Protocol Violations. * Regularly performs Investigational Product (IP) accountability.* Regularly reviews the status of contents of the site Regulatory Binder.* Resolves problematic issues in a productive way.* Exhibits effective time management skills.
4. Data Handling* Performs source document verification (SDV) according to contractual requirements.* Assures timely completion and submission of CRFs according to Clinical Monitoring Plan (CMP) and / or Data Management Plan (DMP). * Assures timely and accurate completion of Data Clarification Forms (DCFs).* Performs clinical data listings reviews as needed.
5. Reporting and Tracking* Completes and submits visit reports according to SOP/WI or sponsor requirements and requiring minimal revisions.* Maintains awareness of key study performance indicators for own sites, e.g. TCRs, patient enrollment, SAEs. * Updates study and patient status information and serves as (CTMS) resource for PM/LCRA.* Tracks Investigator payments/ milestones, if requested.* Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit.
6. Administrative* Prepares for and attends investigator's meetings as requested. May present as requested.* Assists with the preparation of study start up materials and tools, as requested.* Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project Communication, Monitoring and / or Training Plans.* May assume Lead CRA role and/ or assist with LCRA activities, e.g., tool development, study plans, team training.
Performs other work related duties as assigned. Demonstrates basic understanding of SOPs, WI, FDA and local regulations as well as ICH guidelines. EXPERIENCE REQUIREMENTS:
Educated to degree level in science,or related health care field.* Clinical or related research experience some of which should be independent field monitoring * Experience of monitoring complex Oncology Clinical TrialsSolid Monitoring experience* Broad range of therapeutic expertise * Strong organizational, documentation and interpersonal skills
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