Senior Associate (investigator-sponsored studies) Perm/ UK

Recruiter
Docs International UK Limited
Location
Marlow
Salary
on application
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Investigator-sponsored studies (ISS) Senior Associate (perm)

Bucks or Hampshire

- Do you have experience of working on investigator-sponsored studies (non-client sponsored clinical research requests)?
- Are you an experienced CRA with investigator-led trials experience?
- Do you have experience gained within CRO, pharma or biotech setting?

The ideal candidate will have clinical research industry experience with experience of having worked on ISS/ITT activities.

Responsibilities and key activities include but are not limited to

- Track receipt of investigator-led/non-client sponsored concepts / proposals and EA requests and facilitate / administer ISS or EA process as central point of contact
- Facilitate communication with Sponsor via collaboration with TA/Medical staff (e.g.: acknowledgement of receipt of proposal, provision of scientific comments on protocol for ISS or communication with requesting EA physician regarding next steps following request approval)
- Complete sponsor qualification process (in collaboration with TA /Medical staff as needed)
- Facilitate categorization, review and approval of proposals with medical personnel (including documentation)
- Initiate and ensure execution of Confidential Disclosure Agreement where necessary
- Facilitate team review process sign off for proposals, protocols and amendments and submit for review by Regional Medical TA Head, GDL or review committee
- Support meetings internally and with Sponsor as appropriate (creating agendas, minutes, etc.)
- Provide protocol submission package (or open case package for EA) including product specific safety information, details of ISS (or EA) process and requirements to sponsor for protocol review and start-up activities
- Partner with Global / Regional Operations representative regarding drug forecasting including clinical trial labeling activities, expiry dates / memos as appropriate
- Partner with Global Clinical Pricing on budget negotiations and ensure conduct of Fair Market Value assessment
- Collaborate cross functionally to notify Sponsor of any actions or information required from Due Diligence process
- Initiate and support the contract execution process in collaboration with legal
- Support the collection of ISS Initiation Package documents (or regulatory documentation for EA) and forward for approval
- Enter data (e.g. milestone tracking, enrolment status) and maintain source systems
- Track essential documentation and archive in source system
- Procure updates from the Sponsor regarding enrolment, milestone payments, etc., per contract and initiate and track invoices and payments per contract
- Ensure the provision of safety updates to Sponsor in collaboration with Safety
- Liaise with extremal vendors appointed by the sponsor as necessary
- Assist Global Operations with product reconciliation and destruction as appropriate
- Co-ordinate internal review of publications as necessary
- Support training and co-ordination of local affiliate staff as required
- Act as mentor to develop other Associates / Sr. Associates as required
- Review metrics, assist with measurement of compliance to process requirements
- Communicate status to management as requested
- Identify and escalate issues, and facilitate resolution of investigator-initiated/non-client sponsor cross-functional issues
- Lead or participate in cross-functional task forces or working groups, or process improvement initiatives under supervision of management.

What is required

- Excellent IT skills and ability to work fast and accurately across complex systems
- Valid and current UK working eligibility

Preferred qualifications

- BA / BS/ BSc in the sciences or RN
- Broad experience in life sciences or medically related field, including general biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company

Knowledge

- Ability to understand technical, scientific and medical information
- Understanding of drug development process
- Familiar with concepts of clinical research
- Advanced computer skills
- Experience in interactions with outside vendors, e.g., CROs and contract labs
- Experience with administration of site budgets and grants with supervision
- Experience with development of prospective site-selection criteria
- Detailed knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
- Ability to write and present clearly using scientific and clinical issues terminology
- Experience dealing with time demands, incomplete information or unexpected events
- Good organizational and planning skills
- Experience working effectively in a team / matrix environment

What is offered

- Permanent contract of employment with DOCS seconded to the client
- Full-time
- Office-based in the UK, either in Marlow (near Maidenhead) or in Hampshire (Eastleigh). Possibility of working fully home-based depending on client's requirements.
- Salary will depend on actual level of experience and skills
- UK benefits to include 23 days annual leave, pension, healthcare cover, etc.Why Join DOCS?
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- *Applicants who have not had a response within two weeks should assume their application has been unsuccessful.
- Work with the best! This is a great opportunity to further develop your career. To express your interest please send your CV today to find out more details to ********************************* or ring +33 964 25 67 65.
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