1. NANCY MACDONALD
Rose Cottage, 5 East Road, Isleham, Cambridgeshire, CB7 5SN
Email: Nancy-macdonald1@hotmail.com Mobile: 07950 545542
I have a highly committed attitude to professionalism and quality with 11 years’ hands-on
experience in all aspects of clinical trial administration. I am well versed in liaising with
healthcare professionals. I have profound knowledge in handling and collating duties to
manage clinical trial documentation.
CORE COMPETENCIES:-
 ICH-GCP  MS Office  CTMS and Sharepoint
 Excellent
organisational
and
interpersonal
skills
 Mentoring skills  Managing conflicting
deadlines
SELECTED ACHIEVEMENTS:-
 Instrumental in taking studies through successful client audits with no significant
findings of the TMF. I also played a key role in the preparation and participation of a
successful MHRA inspection.
 Lead CTA on global projects resulting in a huge amount of co-ordination and liaison
with other team members from start to end of the project.
PROFESSIONAL EMPLOYMENT
Mar 2008 - Present Senior Clinical Trials Assistant, SynteractHCR Ltd (SHCR), Ely
 Interface with Client representatives and SHCR study team to ensure timely initiation
and completion of clinical trials. Assisting with all aspects of trial management in
accordance with the ICH-GCP, applicable local regulations and Standard Operating
Procedures.
 Serving as a mentor to junior CTAs by providing guidance, training and direction in
project-related tasks and departmental processes.
 Creating Trial Master Files and Investigator Site Files and support in maintaining these
for the duration of the study.
 Maintaining and updating project-related data in an existing database (CTMS) which
involves liaising with internal team members to gather information and resolve queries.
This includes preparation of status reports for the study team and client.
 Assisting in the preparation, receipt, collection, tracking and review of essential
documents to confirm completeness.
 Arranging translations of study documents for global studies.
 Assisting in the planning, organisation and execution of project-specific meetings.
Page 1 of 4

2.  Preparing and contributing to study related correspondence, including meeting
minutes, tracking spreadsheets and presentations.
 Responsible for the shipment and tracking of trial materials.
 Contributing to preparation, support and follow-up of study specific audits.
 Developing/adapting documents according to study related requirements.
 Accompanying CRAs on site visits.
Apr 2006 – Mar 2008 Clinical Trials Administrator, Astex Therapeutics Ltd,
Cambridge
 Filing and tracking study related documentation in TMFs and eTMFs using Sharepoint.
 Management of clinical document storage facilities (electronic, fire safe and off-site
archiving). Nominated archivist for clinical trial documentation.
 Assisting in submission of clinical trial documentation to the regulatory authorities and
ethics committees.
 Arranging and taking minutes at Product Team meetings.
 SOP controller for all company SOPs related to Clinical Trials. Assist in compiling and
reviewing specific SOPs.
 Control of quality documentation relating to CRO, Site and internal audits.
 Supportive administrative role for the Clinical Operations Team.
Nov 2004 – Apr 2006 Clinical Trials Administrator, Cambridge Clinical Research
(CCR), Bottisham, Cambridge
 Responsible for the preparation of start up documentation relating to REC and Trust
R&D submissions in line with the European Directive and ICH-GCP.
 Updating study tracking software for study status reporting.
 Support in co-ordination of study related meetings – Investigator, site selection and
initiation; co-ordination with the site and sponsor company.
 Supporting the Business Development Manager in the co-ordination of outgoing and
incoming feasibility to meet required timelines.
 Responsible for study filing and archiving.
Apr 2002 – Nov 2004 Office Administrator, Cambridge Clinical Research
 Responsible for general office & clinical trial administration.
 Generation of clinical trial document templates.
 Managing a system for tracking clinical trial documentation.
 Filing business and clinical trial documentation.
 Arranging & organising internal and external meetings.
 Management of diaries & schedules.
 Booking flights/transport & hotel accommodation for training courses.
 Personnel issues such as recruitment, training and arranging honorary contracts.
 Facilities management.
Jan 2002 – Mar 2002 HR Secretary/Administrator, NHS Executive, Cambridge
(This was a 3-month temporary assignment)
 Preparation of adverts and interview paperwork.
 Collating CVs, job descriptions and personal specifications.
 Management of personnel files.
 Answering queries, organising meetings/conferences, diary management and
supporting the Workforce Development team with any other HR administration.
Nov 2001 – Dec 2001 Various short term temporary administrative assignments
Page 2 of 4

3. Oct – Nov 2001 Administrative Assistant, BioRobotics Ltd, Cambridge
 General administrative and secretarial duties for the Field Applications and Laboratory
Managers.
 Arranging travel and accommodation for the company personnel and clients.
 Organising monthly lab courses held within the company. Co-ordinating all course
material and collating customer questionnaires.
 Management of documentation both paper and electronic. Filing, indexing and
cataloguing.
 Covering reception to include tracking and checking invoices, purchase orders and
deliveries.
Apr – Oct 2001 Tour Administrator, ETS Travel, Stapleford, Cambridge
 Tour operation of school & educational tours.
 Liaising with suppliers and support departments with respect to transport, visits and
accommodation.
 Raising and tracking tour invoices and chasing and processing payments.
May 1998 – Apr 2001 Continuing Professional Development Administrator,
Addenbrookes NHS Trust, Cambridge.
 Arranging training courses and conferences for GPs, including managing the training
budgets.
 Processing meeting requests and payments for the Postgraduate Education
Allowance System for GPs.
 Maintenance of Doctors' Retainer Scheme database.
 General secretarial support to six Directors.
 Arranging and taking minutes at meetings.
Jan 1997 - May 1998 Administrative Officer, MRC Dunn Nutrition, Cambridge
 An administrative role on the National Diet and Nutrition Survey for Young People.
 Assisting with the recruitment of phlebotomists.
 Regular liaison with the Office for National Statistics.
 Organising briefings.
 Data entry of confidential client information.
Jun 1995 – Aug 1988 Various Travel Consultancy positions
FURTHER EDUCATION AND PROFESSIONAL QUALIFICATIONS
Jan 2015 SHCR – GCP Update & UK Legislation Refresher
Aug 2014 SHCR – EU Clinical Trial Regulation
Feb 2014 SHCR – BioClinica OnPoint CTMS
Jun 2010 ECCRT, Brussels – CTA Workshop
Mar 2010 SHCR – Ethics and R&D Workshop
Page 3 of 4

4. Mar 2009 SHCR – Clinical Trial Directive & UK Legislation; European Regulatory
Requirements (updates every 2 years thereafter)
Jan 2009 SHCR – ICH – GCP Training (updates every 2 years thereafter)
Nov 2008 SHCR - Introduction to Pharmacovigilance
Sep 2008 SHCR - International CTA workshop
Jun 2007 Astex Therapeutics – Archiving Clinical Trial Documentation
Oct 2004 Adamas Consulting – Clinical Trials Auditing
Jul 2003 ICR – Clinical Trial Administration ‘Beyond the Basics’
Feb 2003 Adamas Consulting – GCP for Administrators Course
2000 Cambridge Regional College – NVQ Level 3 in Administration.
1997 Cottenham Village College, Cambridge – RSA Grade 3 in Word
Processing, RSA Grade 1 in Computer Literacy
EDUCATION
1983 - 1985 Colchester Institute, Colchester – A-Level French
1978 - 1983 St. Mary’s School, Colchester – O-Level French, Maths, History, Music,
Geography, English Literature and English Language
INTERESTS Theatre, travel, interior design, gardening, keeping fit, baking and
entertaining
REFERENCES By request
Page 4 of 4