| 1699 Berkshire | Clinical Scientist
Clinical Scientists urgently required to provide study-level medical and scientific support in conjunction with the Global Medical Monitor for paediatric or adult international vaccine studies. The main job responsibilities will be: study protocol design and development; creation of informed consent form (ICF) templates; to lead medical input for, and participate in Case Report Form (CRF) and Integrated Data Review Plan (IDRP) development; clinical data review and interpretation (responsible for review of subject level data across a study); clinical study medical oversight in collaboration with the Global Trial Leader; tracking and reconciliation of Serious Adverse Events, facilitating safety review team meetings, timely communication of safety issues to Investigator sites and review of subject narratives; creation of medical training and investigator materials; provide scientific/medical input, review and edit clinical study reports. Support and contribute to regulatory filings, and participate in publication strategies. Candidates will ideally be qualified to first degree level in science or health-related field and have at least 5 years related experience. In addition, scientific/medical knowledge to author and understand a protocol and other study documents prepared by Medical Research is essential. Other key skills should include:
• Working knowledge of statistics, data analysis and data interpretation
• Excellent written and oral communication, organizational and cross functional collaboration skills
• Proficiency in MS Word, Excel and Powerpoint
Vacancy Reference Number: 1699 |
| 1698 Co Durham | Product Development Engineer
Enthusiastic Product Development Engineer urgently required to work on the development of personal protectice equipment. Ideally candidates will have a degree in pure or applied science and have experience of material properties and process technology. Key skills are project management and team working. Full job description available.
Vacancy Reference Number: 1698 |
| 1695 South East England | Nurse
Bank Nurses and Bank Technicians required with experience in acute clinical areas such as Medicine, ITU/CCU, Theatres and Recovery to assist with monitoring the safety and wellbeing of healthy volunteers and patients who take part in clinical trials. Technicians should have experience of working at NVQ level 3 within a healthcare environment or have previous experience as a theatre technician or paramedic. Applicants for these posts must have the availability to work a minimum of 8 shifts per month mainly on weekdays Mon-Fri, on a consistent basis when requested to work. The majority of shifts offered are early and late duties but some weekend and overnight work may be available following a period of continued experience. Required skills include: use of patient monitoring equipment, recording 12 lead ECGs, blood sampling by venepuncture, good organisational skills and the ability to integrate and work well within a varied team of clinical professionals.
Applications would also be welcomed from nurses with experience in Practice Nursing or Occupational Health Nursing to assist with the recruitment and medical screening of healthy volunteers and patients. Applicants for these posts must have availability to work a minimum of 2 days per week during weekdays Mon-Fri, on a consistent basis when work is available.
For all Bank Nurse and Technicians posts, a significant level of commitment is required to maintain initial training and to update knowledge within this highly regulated environment on an ongoing basis. Possession of a current BLS/ILS/ALS certificate would be advantageous
Vacancy Reference Number: 1695 |
| 1694 Cambridge | Pharmacist / Pharmacy Technician
Pharmacist or Pharmacy technician urgently required to assist in the general day to day maintenance and smooth running of the Pharmacy area and in the preparation and dispensing of clinical trial drugs. You should be available to work between 07.30/8am and 4pm, 2-3 days per week. You should have first class documentation/record keeping skills and be willing to undertake training in Good Manufacturing Procedures, Standard Operating Procedures and Good Clinical Practice. The successful candidates would be comfortable in working within a highly regulated clinical environment and should be willing to assist/participate in self inspection, clinical compliance and regulatory audits.
Vacancy Reference Number: 1694 |
| 1687 Cambridge | Clinical Project Manager
Clinical Project Manager required to cover the following job responsibilities: - review / preparation of draft clinical study protocols - review / preparation of draft Investigator Brochures - review of draft Case Report Forms for clinical studies - review / preparation of draft patient/subject informed consent forms for clinical studies - review / preparation of draft Ethics Committee submissions for clinical studies - review / preparation of draft clinical study reports - review / preparation of periodic project progress reports for clients - review / preparation of Standard Operating Procedures - monitoring of clinical study sites as appropriate, including pre-study, initiation, monitoring and close-down meetings with clinical study investigators - identification of clinical investigators - management of the Trial Master File for clinical studies as per GCP - management of the creation and maintenance of study-specific forms - management of the creation of Investigator Site files - management of the collation and copying of documents for Ethics Committee submissions - management of the archiving of study documents at the close of a project - organisation and planning of study-related meetings - handling of telephone and other enquiries from study site staff and clients during a study, as appropriate - management of the reporting of adverse events, as appropriate - to assist with the preparation of training course materials - to assist with the provision of training courses, as appropriate - liaison with clients, acting as the prime contact for the management of clinical projects. In addition there will be some business development, marketing and general office duties. This is an office based position and would suit someone with experience of running Phase 1 and/or Phase II clinical trials - ideally with several years relevant experience from working in a pharmaceutical/healthcare product development environment.
Vacancy Reference Number: 1687 |
| 1686 Surrey | Clinical Project Leader
An opportunity has arisen for an office based clinical project leader to work within the Clinical Operations Department to manage UK trials in the Oncology, CVS or Metabolism therapeutic areas. Main duties will include: managing clinical trials to ensure completion on time, within budget and to the highest possible standards; in accordance with protocols, UK regulations, GCP guidelines, company SOPs and other prevailing standards of best practice. In particular, to coordinate the extended project team, working within a matrix structure, develop accurate project plans, carry out risk analysis and generate contingency plans to meet significance risks to project completion. In addition, to monitor progress of projects to enable effective and accurate reporting and project control, carry out trial feasibility and prepare file submissions to the RECs and assist with the Competent Authority submissions. Other responsibilities include preparation and tracking clinical trial budgets and ensuring studies come in on budget, write / validate the technical and/or administrative documents which are necessary for the trial, and organize the local investigators meetings, when required. You will also ensure timely initiation of study centres, appropriate follow-up (co-monitoring, review of reports, recruitment tracking) and close-out (files archived, IP and trial material collected) of study centres; train the CRAs to the study specificities and assist with centre allocation and CRA workload review.
Vacancy Reference Number: 1686 |
| 1682 West London | Nurse
We have an urgent requirement for a Nurse to work in a clinical drug discovery and development unit based in London. In this role you would be responsible for scheduling, planning and implementing volunteer recruitment activities for research studies according to defined clinical protocols, regulatory requirements and standard operating procedures. Candidates should be a Registered Nurse or NVQ level 3 with experience in Critical Care or another acute clinical area, and have good written and verbal communication skills. Candidates also need to be computer literate and able to manage complex workload, at the same time maintaining good attention to detail. Previous experience in a clinical research or psychiatric environment would be a distinct advantage.
Vacancy Reference Number: 1682 |
| 1680 Cambridge | Regulatory Specialist
Regulatory Specialist urgently required. This role entails: review/preparation of clinical trial applications; preparation of orphan drug designation applications (EU & US); preparation of IND applications / annual updates; organisation of and attendance at meetings with regulatory authorities; management of archiving of study documents at close of project; review / preparation of SOPs; organisation / planning of study-related meetings; client liaison, and maintenance of regulatory records. Candidates should ideally have a life science degree and have 2-3 years practical experience with IMPDs and MAAs.
Vacancy Reference Number: 1680 |
| 1672 Berkshire | Technical Affairs Engineer
Technical Affairs Engineer urgently required to give technical & administrative support to European Technical team specifically in the areas of product testing & approval, manufacturing site certification documentation, and supporting regional Technical Affairs with information on products, standards & approvals.
Key job responsibilities include:
assist European Technical Affairs Engineers and Approvals Supervisor in creation & maintenance of product testing & approval documentation.
• assist manufacturing sites with certification documentation.
• maintain CE certificate files.
• maintain procedures & work instructions.
• load CE certs/DoCs, datasheets etc onto digital library.
• maintain purchase order & budget spreadsheet.
• maintain a database of Tech Enquiries
Ideally candidates will have a science Degree and have experience in Health & Safety,
technical customer support and quality systems in
medical, pharmaceutical, or health care industry
Vacancy Reference Number: 1672 |
| 1668 Europe | Project Manager
Experienced clinical project manager required to work on a large, international diabetes clinical trial with management responsibility across the Czech Republic and Slovakia.
The project manager will co-ordinate all aspects of study management and be working closely with, and supporting the Regional and Global Project Manager. The project manager will ensure the study is resourced effectively, managed efficiently, achieve project objectives within allocated budgets and agreed timelines and are conducted to the highest standards of Good Clinical Practice (GCP), regulatory requirements and Standard Operating Procedures (SOPs).
The project manager will mentor/coach Clinical Research Associates (CRAs) working on the project within Czech Republic and Slovakia and assist with their technical development. The project manager is also responsible for ensuring the project is delivered to high-quality standards and timelines, and will report status and performance of the project, including key performance metrics, to the regional and global PMs as required.
Key Roles & Responsibilities are therefore: Staff Development & Training; Study Start-up; Study Execution, and Study Closeout.
Vacancy Reference Number: 1668 |
| 1666 South East | Biometrician
Biometrician urgently required by blue-chip pharmaceutical company based in south-east England. The role will be part of a small team of Biometricians working closely with a larger team of statisticians in the US.
The statistical support involved includes the provision of statistical input to study protocols, development of randomisation and statistical summary and analysis programs, advising on statistical content of study reports and regulatory filing documents. After an initial period, the successful candidate will take the role of lead biometrician for one or more projects. Other duties include will include:
assisting in Biometrics training sessions; participating in the development of improved global statistical procedures - reviewing and updating Biometrics SOP’s and guidelines, validation checks and procedures, and evaluating and implementing improved statistical procedures; liaising with colleagues in the US to ensure that a common approach is taken to analysing clinical study data, and keeping abreast of the relevant biometric advances and recommend changes and new statistical techniques.
Ideally candidates will have a minimum qualification of a BSc in applied statistics or related discipline, and have good knowledge of basic statistical techniques and the ability to program in SAS.
Vacancy Reference Number: 1666 |
| 1659 Cambridge | Clinical Research Associate
A Senior Clinical Research Associate is urgently required to work closely with the Directors, Clinical Project Manager, Clinical Research Executive and other staff in technical aspects of the business, but also in some business development and general office organisation tasks.
Main job responsibilities will be the review / preparation of draft clinical study protocols, draft Investigator Brochures, draft Case Report Forms for clinical studies, draft patient/subject informed consent forms for clinical studies, draft Ethics Committee submissions for clinical studies, periodic project progress reports for clients, Standard Operating Procedures; monitoring of clinical study sites as appropriate, including pre-study, initiation, monitoring and close-down meetings with clinical study investigators
identification of clinical investigators; management of the Trial Master File for clinical studies as per GCP, creation and maintenance of study-specific forms, creation of Investigator Site files, collation and copying of documents for Ethics Committee submissions, archiving of study documents at the close of a project; organisation and planning of study-related meetings, handling of telephone and other enquiries from study site staff and clients during a study, and management of the reporting of adverse events. In addition there will be the opportunity to assist with preparation of training courses and training materials, and to assist with business development and marketing.
Vacancy Reference Number: 1659 |
| 1653 London | Bank Nurses
We are currently recruiting for our team of Bank Nurses to support clinical study activities. This an exciting opportunity for nurses to broaden or develop experience in clinical research within the pharmaceutical industry. Previous experience in a clinical research environment would be an advantage as would skills gained in critical care, A&E or a similar acute environment. Nurses applying should have flexible and regular availability for Bank work particularly during weekdays, basic keyboard/computer skills, an interest in research, and high professional standards of clinical care. Experience in recording ECGs, venepuncture and cannulation would be helpful. The majority of shifts available will be early shifts starting at around 07:30am and late shifts finishing at around 8pm although this may vary depending on the studies being conducted.
Vacancy Reference Number: 1653 |
| 1652 London | CTA
Clincal Trial Administrator urgently required to be responsible for assisting the clinical team with all aspects of administration relating to clinical trials and to undertake specific training outside of core expertise in order to provide additional resource needed for other activities as and when required. The clinical trial administrator will have good secretarial and/or administrative skills, be a good communicator, have a professional and pleasant telephone manner, experience with dealing with the general public in a medical environment, and be computer literate.
Vacancy Reference Number: 1652 |
| 1650 London | Research Nurse
Clinical Research Nurses urgently required to work on studies a west London drug discovery and development centre. As a research nurse you would have the opportunity to contribute in accelerating the introduction of new pharmaceuticals for the treatment of disease. You would be responsible for facilitating the conduct of in-house Imaging/Experimental Medicine studies across a range of therapeutic areas. As the research burse you would coordinate the planning, nursing and administrative activities in accordance with defined clinical protocols, regulatory requirements and standard operating procedures. You should be a Registered Nurse with previous experience in an acute clinical area, preferably CCU/ITU/A&E. Experience in the conduct of clinical trials would be an advantage particularly if industry based. You should be able to work with complex equipment and adapt to new technologies. Computer literacy and strong communication and interpersonal skills are required.
Vacancy Reference Number: 1650 |
