A leading specialised services company, which supports pharmaceutical and life sciences companies, is currently looking for a Senior CRA to join their UK team on a home-based capacity.
- Managing appropriately sized clinical trialsa and supporting Project Managers with trials that are larger in scope.
- Focussing on training and mentoring junior staff members may also be expected from the Sr. CRA.
- Serving as a member of the project team with the goal to contribute towards efficient management of trials.
- Assisting the team managers in the preparation and review of protocols and other study documentation.
- Designing and developing CRF and clinical trial document development as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.).
- Overseeing all aspects of study site management to ensure the quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
- Establishing, updates, tracks and maintains study specific trial management tools/systems, and status reports.
- Managing site start up procedures including the recruitment of potential investigators, preparation of EC/IRB submissions, notifications to regulatory authorities, translation of study related documentation, organization of meetings and other tasks as instructed by the project manager.
- Negotiating study budgets and assists with the execution of investigator contracts.
- Conducts all forms of monitoring visits, including pre-study, initiation, routine, and final monitoring visits, in accordance with the protocol, local laws, ICH-GCP and company Oncology's SOPs.
- Preparing accurate and timely visit reports from all monitoring visits.
- Communicating effectively with both site personnel and company's Oncology management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
- Developing and maintaining good working relationship with investigators and study staff, serving as an ambassador to promote company Oncology's high quality and ethical image.
- Maintaining studying tracking, in accordance with the demands of the study.
- Performing data management activities, including in-house CRF review, query resolution, and resolves data discrepancies, dependent upon the study/sponsor arrangement.
- Identifying and processing Serious Adverse Events according to the procedures defined by the study team.
- Demonstrating a full understanding of the SAE reporting process and when required, may write narratives and follow-up on SAEs as needed
- Functioning as a mentor, assisting with the training and developing of new employees and junior monitors.
- Assisting with the development of SOPs
- Assisting with review of clinical study reports.
- Conducting feasibility work when requested.
- Interacting with client, participates in proposal activities, including development and client presentations.
- Initiating payment requests for investigators.
- Assuming project management responsibility as needed.
- Performing other duties as assigned by management.
Skills and Requirements:
- 3 years or more as a CRA either in CRO or Pharmaceutical industry.
- Graduate, postgraduate, 4-year college degree, or equivalent experience ideally in a scientific or healthcare discipline.
- Demonstrates mastery knowledge of ICH-GCP, relevant company Oncology's SOPs, and regulatory guidance, as well as the ability to implement.
- Resolves project related problems and prioritise workload to meet deadlines with little support from management.
- Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective.
- Understands clinical trials methodology, including a working knowledge of protocols and indications being studied.
- Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
- Identifies training needs for direct reports and develop training plans to address those needs.
- Collects data of consistently high standard.
- Communicates both verbally and in written form in an acceptable manner.
- Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency.
- Works within a project team, and where necessary, leads a local project.
- Possesses basic understanding of financial management.
- Availability for domestic and international travel including overnight stays.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Reem Iskandarani at 0203 854 2629 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.