Email:sarahharkness_767@hotmail.com

Sarah Harkness

Personal statement

I am a bright, driven and outgoing individual with experience in research in both a non-clinical and clinical setting. My impetus for personal development and eagerness to learn has pushed me to seek this new and exciting challenge.

Key transferable skills

My CV demonstrates, through my previous and current roles, that I possess key attributes necessary to become a successful CRA. These include:

Exceptional time management and task prioritisation skills Strong communication skills Key focus on role goals and deliverables Attention to detail and fastidious approach to data quality

Current employment

Clinical Research Associate (South East) with Novo Nordisk-Gatwick (Oct 2014-Present)

Previous employment

Clinical Trials Approval Officer with Novo Nordisk-Gatwick (Nov 2013-Oct 2014)

As a CTAO I was responsible for the set up and maintenance of multiple drug clinical trials. I would liaise with site personal, PMs, CRAs and CTAs on a daily basis, making sure site SSIs have been submitted, contracts have been signed and R&D approvals has been issued within the set study timelines. I am also responsible for Ethics and R&D submissions via IRAS, coordinating substantial and non-substantial amendments and managing confidentiality agreements. My role as a CTAO required accuracy, exceptional time management skills and keen attention to detail. Although a close knit member of the CASU team, I was able to work individually, as I am self-motivated, clear minded, pragmatic and able to cope under pressure thus allowing me to adhere to strict deadlines.

Clinical Trial Coordinator within the Haemato-Oncology Research Unit at the Royal Marsden NHS Foundation Trust-Sutton (Dec 2012-Nov 2013)

I was responsible for the coordination of complex Heamato-Oncology studies, some of which had up to 20 treatment arms. Of these clinical trials, 4 were academic and 6 were commercial. I was also solely responsible for the data management of 4 of these trials.

My day to day activities as a CTC included:

The setup and maintenance of studies within the portfolio. This included reviewing protocols, negotiating trial budgets and contracts, collating all necessary documentation ready for R&D review and Sponsor green light, processing amendments, preparing site for set up, close down and archiving.

Liaising with various personnel including professors, clinicians, pharmacists, radiographers and nurses as well as R&D, LCRN, CRO and pharmaceutical staff.

Reviewing capacity and resource requirements within the research unit as well as coordinating Pre-Study Visits (PSVs) and Site Initiation Visits (SIVs)

Creating Investigator Site Files for academic studies while maintaining ISFs for commercial studies. I was also responsible for maintaining delegation logs, staff training logs, Financial Disclosure logs and Confidentiality Agreement logs, as well as making sure all members of the research team were GCP trained

Completing both paper and electronic (InForm, Medidata Rave) CRFs using source data worksheets and patient notes (both electronic and paper).

Responding to data queries from the Sponsor and/or CRO and adhering to strict data cut deadlines. Also involved in processing protocol deviations and ensuring safety reports had been reviewed and signed by study PIs.

Assisting nurses and clinicians with the completion of AEs, concomitant medicines, SAE and SUSAR forms.

Preparing for audits and HTA inspections

Using prescription charts to complete CRF pages on dosing and drug accountability

Involved in the storage, handling, sending, ordering and destruction of lab kits

Representing our site at Investigator Meetings when necessary, both in the UK and abroad

Presenting at teaching sessions for new SpRs, as well as presenting to professors and clinicians at monthly trial meetings.

Clinical Trial Administrator within the Head, Neck and Thyroid Oncology Research Unit at the Royal Marsden NHS Foundation Trust-Sutton (Jul 2012-Dec 2012)

I was responsible for the data management of eight clinical trials in total. These were a mixture of commercial and academic CTIMP and radiotherapy studies, using both paper and electronic CRFs. I was also responsible for processing and implementing study amendments and maintaining site files.

Courses

‘Seeing the Forest through the Trees’ provided by Novo Nordisk-3 days (Jan 2014) ‘Creative presentations’ provided by The Royal Marsden NHS Foundation Trust-1day (May 2013) I was selected to attend the ‘Pan London and South East Cancer Research Networks and South East CLRN Cluster Training and Development Collaborative Course’ -Five 2 day modules (Feb 2013-Jul 2013)

Education

The highest scoring First Class Honours degree in Biochemistry (Pharmacology) at the University of Surrey (Sept 2008-May 2012)

For each year of study I attained performance based scholarships from the University. Success in my degree demonstrates that I am a logical, organised and concise individual, quick at picking up new concepts and able to prioritise to meet targets. I was able to give presentations on several occasions throughout my degree; the most prominent being at the Festival of Science where I was put forward to present my research from my final year dissertation. This was later recognised and awarded as the best biochemistry project. This has helped me to become a better communicator and gain confidence in presenting ideas to others.

Third year- Industrial year placement with GlaxoSmithKline-Stevenage (September 2010-August 2011)

I was a research scientist within the Respiratory department for R&D. My work established suitable biomarkers, an optimum time point for samples to be collected from patients post drug dose and an appropriate double immunocytochemical labeling technique to be used to analyse Phase 1 clinical trial samples taken in October 2011. For my work throughout the year I was awarded a bronze recognition award by GSK and a distinction by the University.

Steyning Grammar School -West Sussex

A levels (2008)- Biology (A), Chemistry (B), Physics (C)

As levels (2007)-Maths, Critical thinking

GCSE’S (2006)-2 A*’s, 6 A‘s, 3 B‘s and a C including all Sciences and two languages.

Work experience

Work experience with the Clinical Research Team at The Royal Surrey Hospital-Surrey -2 days (Jun 2012)

Casual seasonal work with Goodwood Food-Chichester (from Jun 2009 to Jun 2012 )

Sixth Form work experience with Novartis-Horsham ( Feb 2008)I worked in a variety of departments including; Biologics, Discovery, Robotics, Screening and Cheminformatics.

Housekeeper with Amberley Castle Hotel Limited-Amberley (Jun 2004 –Feb 2009)  

Interests and achievements

I achieved Singing (Grade 8), Piano (Grade 5) and music theory (Grade 5) before reaching the age of 16.

I have a clean full UK driving license

References -Available upon request