2 Globeside Business Park , Marlow , Buckinghamshire , SL7 1HZ |
|
|
|
| Job Title |
|
Home Based Freelance CRA - Portugese Speaker |
| Location |
|
UK, Non UK |
| Job Number |
|
120260997 |
| Posted |
|
17/05/2012 (11:21) |
| Agency/Employer |
|
Docs International UK Limited |
Description
|
|
CRA required - 6 month contract
Are you currently a Freelance CRA/sCRA looking for a new position! Look no further as we are currently recruiting for Freelance CRA who is able to speak Portuguese can be based anywhere and will be remote monitoring so no travel required
The Role and your Responsibilities
Working within a highly qualified team you will identify, select, initiate and close-out investigational sites for clinical studies in phases II - IV ensuring adherence to applicable regulations and principles of ICH-GCP.
Responsibilities:
You will work independently and proactively to coordinate all necessary activities required for setting up and monitoring a study, completing accurate study status reports and maintaining study documentation. You will be involved in the submission of protocol, consent documents for ethics/IRB approval and assist in the preparation of regulatory submissions as requested.
Managing sponsor generated queries efficiently and taking responsibility for study cost effectiveness; you will also participate in the preparation and review of study documentation and feasibility studies for new proposals as required.
Must have previous CRA experience.
Must be competent in Start-up, initiation, Monitoring and close out of studies. Have worked on a contract assignment before. Therapy area experience in: CNS, Oncology, Cardiovascular and Anti-Invectives
If this is of interest please contact Vicki Wilson.
|
| Job Type |
|
Contract |
| Contract Length |
|
6 months |
| Start Date |
|
|
| Contact Details |
|
 |
|
|
|
|
| Job Title |
|
CTA (Clinical Trial Administrator) Cambridge |
| Salary/rate |
|
£19000 - £21000/annum 27 days holiday, pension, medical |
| Location |
|
Cambridgeshire, East Anglia |
| Job Number |
|
120259846 |
| Posted |
|
08/05/2012 (14:51) |
| Agency/Employer |
|
Docs International UK Limited |
| Description
|
|
CTA (Clinical Trial Administrator) Cambridge
Permanent opportunity
Do you have solid UK administrative and IT skills?
Are you looking for your first step in clinical research?
Then this CTA position is for you!
The Role and Responsibilities
Our client is looking for a hard-working and efficient administrator with excellent IT skills who is looking for their next career step as a CTA / Clinical Trial Administrator.
Our client can offer the opportunity to learn the CTA role as on-the-job training will be provided and you will be part of an established, hard-working and close-knit CTA team. You will learn all aspects of CTA work from submitting ethics submissions to clinical start-up activities.
What is Offered
Excellent support and training opportunities;
Competitive salary depending on level of experience and skills, salary ranging from £19,000 to £21,000 per annum;
Permanent contract of employment with generous company perks (27 days holiday, pension, medical health insurance and more), seconded to our client on a 12-month renewable basis;
Office location in Cambridge;
Ideal start date: immediately though negotiable for the right candidate.
The Clinical Trial Administrator / CTA
Is responsible for study start up activities and coordinates preparation of local study documentation relating to: clinical study timelines for all studies conducted in a country, recruitment plans and strategy, informed consent form, draft clinical metrics reports;
Coordinates the preparation of the submissions and local tracking of applications to IRB/ IEC;
Ensures collection, review, track and provision of appropriate clinical documents to support regulatory submission
Develops and maintains an effective relationship with local Regulatory Affairs to ensure consistent working practices for EC/IRB & Regulatory submissions;
Ensure IND safety reports are submitted to central Research Ethics Boards (Canada & US);
Initiates and validates payment requests as required, ensuring that payment requests are within contract and based on milestones;
Prepares and maintains local study documentation relating to Site Initiation Package (SIP) requirements (coordinates activities associated with start-up including updating systems), Amendments, Clinical study timelines and ICF
Collates and completes SIP, reconciles study documents, collates study specific data and generates local metrics reports, coordinates local data entry into study management systems and creates and completes tracking documentation as applicable;
Processes, distributes and tracks essential documents and submits them to the relevant department or local archive in compliance with the companys SOPs;
Prepares and tracks confidentiality agreements
Collates and distributes study supplies to sites; provides support to responding to local audits and inspections; responds to clinical trial queries;
Orders, processes and tracks Case Report Forms (CRF) and follows-up on query resolution if required to do so
Acts as a single contact point for Clinical Trials Insurance process
Completes tracking documentation as applicable including but not limited to spreadsheets
What is required:
Ideally BA/BS/BSc or qualified nurse;
Co-ordination/administration experience, ideally gained within the industry or working in the R&D office of an NHS trust/hospital compiling and/or reviewing study applications;
Work involving data entry into systems/databases and/or business support;
Excellent MS Office working knowledge and able to learn effectively new software packages;
Ability to work independently with a flexible can-do approach to work;
Policy, process and procedural conformity;
Candidates must be eligible to work in the UK.
Why this Vacancy is right for you
Established and successful company;
Permanent contract of employment seconded to our client on a 12-month renewable contract basis.
Please send your CV today to find out more about this fantastic career opportunity to Elisabeth Knighton
*Applicants who have not had a response within two weeks should assume their application has been unsuccessful.
|
| Job Type |
|
Permanent |
| Contract Length |
|
Permanent |
| Start Date |
|
as soon as poss |
| Contact Details |
|
|
|
|
|
|
| Job Title |
|
Clinical Project Manager - Ireland |
| Location |
|
Ireland, Non UK |
| Job Number |
|
120259796 |
| Posted |
|
08/05/2012 (12:17) |
| Agency/Employer |
|
Docs International UK Limited |
| Description
|
|
Clinical Project Manager - Ireland
The Role and Person:
The candidate must have a Science degree and at least 3 years experience working in Clinical Research (Phase II & III). They should have a flair for scientific writing (protocols and reports) and be fully conversant with the use of EDC in clinical trials.
The successful candidate will have broad international experience both in the Pharma and CRO industries. Familiarity with the requirements of European regulatory agencies would be a distinct advantage.
The selected candidate will be a dynamic individual, capable of working on their own initiative and would be required to travel extensively (2 days per week across CRO sites in Europe).
In addition to job spec, the successful candidate would be expected to manage CRO relationships from end to end, i.e. developing and managing RFP process and the working relationship after selection.
Project Management experience would be useful here and some travel will be involved but position will be based out of the Dublin office.
Salary range will be dependent on experience.
Contact; Alex Butcher; Senior Consultant; DOCS Global;
*Applicants who have not had a response within two weeks should assume their application has been unsuccessful.
|
| Job Type |
|
Permanent |
| Contract Length |
|
N/A |
| Start Date |
|
|
| Contact Details |
|
|
|
|
|
|
| Job Title |
|
Pharmacoviligence Manager |
| Location |
|
Berkshire, Berkshire |
| Job Number |
|
120259323 |
| Posted |
|
02/05/2012 (10:27) |
| Agency/Employer |
|
Docs International UK Limited |
| Description
|
|
Pharmacoviligence Manager required for global leader based in Berkshire - to provide pharmacovigilance advice and support to the UK, Ireland and Malta affiliates. To support the Head of Pharmacovigilance to meet statutory pharmacovigilance responsibilities and to help coordinate the safety aspects of device and nutrition vigilance responsibilities. Fulfil National Regulatory Authority regulations with respect to pharmacovigilance (PV), and conform to company standards.
The Role and your Responsibilities
Deputy Affiliate Safety Representative
SOPs:
Ensures local processes and procedures are in place to clearly define pharmacovigilance responsibilities within the Affiliate in line with Global SOPs and local regulations
Compliance:
Ensures a local tracking system is in place, to ensure timely submissions of adverse events to Global Pharmacovigilance (GPV), and of ICSRs and Periodic Reports to the Regulatory Authority
Reports monthly compliance metrics to GPV within the required timelines
Maintains awareness of local PV legislation
Ensures GPV is promptly notified of any changes to relevant Local Legislation
Co-ordinates Affiliate review and submission of periodic safety reports
Completes monthly ICSR reconciliation with interacting departments and/or partner companies (if applicable) and acts upon any discrepancies
o Ensures any changes to Affiliate safety personnel are communicated to the Regulatory Authority (if required by national legislation), GPV and the EU QPPV (if applicable) in a timely fashion.
Adverse Event Processing:
Ensures that local processes, procedures and systems are in place for recording, processing, conducting follow up and translating adverse events from spontaneous and solicited sources and SAEs from clinical studies (where applicable), including pregnancy, overdose, misuse, abuse, medication errors or product quality complaint reports (in association with QA).
Ensures local language medical or scientific literature, not included in GPV global literature review, are reviewed to identify possible adverse events, and that any reports are forwarded in a timely manner to GPV.
Product Complaints:
Ensures product complaints are reviewed for adverse events, and forwards any AEs identified to GPV
Training:
Maintains a version-controlled training matrix for local PV personnel
Ensures training of affiliate personnel on relevant PV responsibilities is undertaken on at least an annual basis, and that appropriate training records are maintained.
Risk Management (RM):
Is a member of the Affiliate Risk Management Team
Safety Monitoring
Monitors the risk/benefit profile of local products and communicates changes or concerns to Global Pharmacovigilance (GPV) and the Qualified Person Responsible for Pharmacovigilance (QPPV) (if applicable) for evaluation
After Hours Availability:
Ensures that an after-hours process is in place and tested (e.g., to respond to Regulatory Authority questions and for emergency un-blinding of treatment codes for Abbott sponsored studies)
Maintains up- to-date information on local Regulatory Authority out of hours contacts
Travel: 0-20%
What is Required
Medical, pharmacy or life sciences Degree (or equivalent)
Enjoy working proactively
Strong communicator
Excellent organisational skills
Excellent team working skills
Project management skills
Awareness of timelines
Direct pharmacovigilance experience
What is Offered
Excellent salary, benefits and progression opportunities with a market leader.
|
| Job Type |
|
Permanent |
| Contract Length |
|
N/A |
| Start Date |
|
Negotiable |
| Contact Details |
|
|
|
|
|
|
