Position 1: Clinical Trials Research Coordinator

Position 1: Clinical Trials Research Coordinator

Irish Blood Cancer Network, Clinical Research Facility,

NUI Galway

Ref. No. NUIG 100-15

Applications are invited from suitably qualified candidates for a fixed term contract as a Clinical Trails Research Coordinator for the Irish Blood Cancer Network (IBCN) based in the Clinical Research Facility at University Hospital Galway. The position is available from October 2015 to contract end date of May 2020, subject to an initial one year probationary period. This position is funded by Science Foundation Ireland and the Irish Cancer Society.

Organisation: The IBCN focuses on research and early phase clinical trials for patients with blood cancers in Ireland. The IBCN will establish phase I capability in three cancer care centres in the country under a unified governance structure as a virtual Phase I trial centre. The virtual trial centre will be led by University Hospital Galway and will extend phase I capability to two other sites in Ireland, one in Dublin (CRF at St James’s Hospital) and the other in Cork (CRF at Mercy University Hospital and Cork University Hospital). The three sites will operate as a single, cohesive national phase I unit catering to a population of 4.6 million people through agreed patient referral from all other national cancer care centres. While the phase I clinical trials will be restricted to the three partner sites, the centre will also support and foster investigator-driven phase I and phase II clinical trials to be run by other hospitals through an Associate Membership model

Job Description: The IBCN wishes to recruit a highly motivated and talented Clinical Trials Research Coordinator (CTRC) to manage and simultaneously coordinate multiple phase 1 clinical trials run by the IBCN. This is a key position and the CTRC will be required to perform his/her responsibilities with a high level of leadership and independence within the scope of study protocol(s) and institutional guidelines. The CTRC will work with the Director Prof Michael O’Dwyer and other network partners and Principal investigators to set up and coordinate the IBCN clinical studies at the three IBCN hospital sites and manage the virtual centre activities. The CTRC will play a key role in the evaluation of proposed studies, will be responsible for protocol implementation, study management and the integration and effective communication between the three IBCN phase I trial sites and he/she will work with the directors, the sponsors and the institutions to drive study set-up, coordination and effective implementation.

Duties:

·  Play a leading role in the set-up of phase 1 clinical trials by driving and providing oversight for all regulatory and ethics submissions and indemnity arrangements for NUIG sponsored studies.

·  Lead and coordinate the activities of administrative and clinical personnel at the three IBCN sites with respect to: preparation of the trial master files; preparation of informed consent; preparation of on-site documentation: implementation of good clinical practices.

·  Design and implement procedures to ensure highly effective coordination and communication between the 3 IBCN sites regarding: site initiation visits, risk assessments, preparation and provision of status reports and budget reports, provision of monitoring reports to sponsor, ongoing monitoring visits, patient recruitment and follow up, patient care,adverse eventreporting, preparing and submitting thecase report formsand other data to the Sponsor as necessary, study close-out, query follow up and resolution.

·  Assist the director and PIs in development of new study concepts and protocols

·  Responsible for monitoring and ensuring that all ICBN sites are fully briefed and prepared to correctly implement study protocols.

·  Responsible for implementing and leading weekly tele- or video conferences between all 3 sites and developing a detailed site-specific work plan for each site.

·  Develop study specific risk-monitoring plans in conjunction with clinicians.

·  Present progress reports to Trial sponsors and organise and participate in all relevant meetings (safety meetings, dose escalation meetings, study management committee etc).

·  Assist Director and study management committee in evaluating the scientific and clinical merits of proposed new trial studies.

·  Work with PIs and Clinicians to identify any potential issues that may arise with the conduct of new study and whether the study procedures are feasible.

·  Responsible for budget set up and management throughout life cycle of project

·  Assist the management committee select new sites for inclusion in the IBCN as time progresses.

Qualifications: Essential

·  Degree in life sciences or medical field.

·  Minimum of 5 years coordinating clinical trials at a leadership level.

·  Experience of leading clinical study teams.

·  Experience implementing Good Clinical Practice.

·  Experience designing clinical trial protocols.

·  Experience evaluating and carrying out statistical analysis of clinical trial results.

·  Demonstrable knowledge of regulatory processes and ethical practices.

·  Ability to problem solve and to prioritize multiple competing tasks in a dynamic environment.

·  Proven leadership skills.

·  Demonstrable communication and interpersonal skills.

·  Accurate attention to detail with ability to working within tight deadlines.

·  Excellent organisational and analytical skills.

·  Flexibility and ability to lead study teams in different locations.

Qualifications: Desirable

·  Postgraduate qualification in clinical studies management/clinical operations management.

·  Previous experience in oncology clinical trials.

·  Previous experience in Phase 1 clinical trials.

·  Previous experience working in translational research in haematological field.

·  Experience and proven ability to navigate Irish, European and FDA guidelines and regulations regarding phase 1 clinical trials.

·  Good project management skills.

·  Demonstrable presentation and diplomacy skills.

·  Negotiation and conflict resolution skills.

Salary: €65,000 fixed per annum per annum

Start date: Post is available from 1st October

For informal enquiries about this post, please contact Professor Michael O’Dwyer ().

NB: Gárda clearance is a requirement for this post.

Further information on research at NUI Galway is available on Research at NUI Galway and the Galway Clinical Research Facility at http://www.nuigalway.ie/hrb_crfg/

To Apply:

Applications to include a covering letter, CV, and the contact details of three referees should be sent, via e-mail (in word or PDF only) to

Please put reference number NUIG-100-15 in subject line of e-mail application.

Closing date for receipt of applications is 5.00 pm on Friday, 18th September 2015

National University of Ireland, Galway is an equal opportunities employer.