NATALIA OLEJNICZAK

Tel: +44-749*-******

e-mail: ad0era@r.postjobfree.com

Personal Profile:

I would describe myself as a hardworking, accountable and well organised person who thrives at the chance of a challenge at work. I like to think I am someone who works well alongside others and easy to get along with as I am sociable person. Looking for a challenging position in life science that will enable me to capitalise on my education and professional experience, with opportunities to expand knowledge and develop new skills. Work experience

Apr’ 20 – present Clinical Trials Monitor/Manager Imperial College London

• Ensure that the studies are conducted in compliance with protocol, overall objectives, FDA/ICH GCP and the local SOPs and are run according to agreed timelines

• Facilitate study set up at participating sites and continue to oversee the clinical operations throughout the lifetime of the trial, including recruitment, inform consent procedure, visit co-ordination and visit scheduling

• Support clinicians and research staff in maximising recruitment and follow up participation. Identify any barriers to effective recruitment and follow up and seek solution in conjunction with the other members of the research team.

• Train the staff from the investigator sites in the conduct of the study, documentation, record keeping and regulations

• Maintain central records for the investigator sites including maintenance of the Trial Master Files (TMFs) and creation, distribution and maintenance of the Investigator Site Files (ISFs)

• Attend regular internal team meetings with the study team and external meetings with the sponsor/CRO

• Set up and attend regular meetings with study staff, through a combination of meetings in person and via teleconference, with staff at the co-ordinating centres, and to facilitate communication between them

• Schedule and co-ordinate Trial Management Group meetings and collate the essential data ensuring appropriate reporting is undertaken and disseminated in preparation.

• Assist with compliance with ICH-GCP and local regulations at all research sites

• Prepare, co-ordinate and supply materials and other research items (e.g.Case Records Forms, protocols) required by sites taking part in the study.

• Conduct regular monitoring visits to participating sites in accordance with the study monitoring plans

• Monitor recruitment / sample collection and assist with site payments, if appropriate

• Perform Source Data Verification (SDV) of study data at participating sites to check original source documents against what has been entered into the study database

• Perform remote monitoring of studies via the online study database to identify, raise and resolve queries in between monitoring visits

• Check patient informed consent forms, ISFs and Serious Adverse Events (SAEs) for accuracy and completeness on study visits

• Perform Site Initiation Visits and study close out visits as required

• Write reports and follow up letters to sites following site visits and to monitor and record follow up of action points resulting from those visits

• Raise any areas of concern identified at site visits with the Clinical Trial Manager, Operations Manager and/or QA Manager as appropriate

• Distribute and supervise all study documentation and equipment required for the purpose of the study

• Arrange with study staff for the creation and maintenance of patient files and study documentation

• Facilitate the correct completion of patient record forms, and to investigate missing forms

• Maintain patient confidentiality at all times

• Undergo training deemed to be necessary for the full execution of trial duties.

• Assist with the preparation and conduct for any future GCP Inspection

• Perform any other duties which may be required that are consistent with the nature and grade of the post as required by Senior Clinical Trial Manager, Operations Managers and Head of Commercial.

• Ensure familiarity with and adherence to all relevant SOPs

• Responsible for ensuring that data is accurate, up-to-date and complete May ’19 – Mar ’20 Project Manager University of Oxford

• Responsible for planning and execution of several research projects and clinical trials according to ICH-GCP standards.

• Support the lead nurses and/or clinical research fellows in the management of the project team to ensure timely and effective completion of project assignment.

• Prepare and regularly update the working protocol for the project in accordance with the requirements of the various controlling bodies, agencies and frameworks.

• Establishment of procedures to ensure adherence to protocols and administrative requirements

• Ensure the timely recruitment of trial participants with secure randomisation processes

• Monitor the project progress to ensure compliance with and adherence to quality standards, SOPs, ICH-GCP and/or other guidelines and to identify, evaluate and rectify problems

• Work with the Quality Assurance Manager on any necessary audit processes

• Work with the Principal Investigator to ensure that the project is meeting its targets, is producing meaningful output and to predict and plan any changes in the protocol, funding or time

• Manage projects pro-actively, anticipating problems and providing resolutions in a timely manner

• Plan and support the meetings and work of the various groups and bodies associated with the project

• Liaise with the IT Manager to ensure efficient and effective data management

• Be responsible for ethics applications, submissions to the regulatory authority, and NHS Research and Development bodies.

August ‘18- April ’19 Research Facilitator LSHTM

• Providing operational administrative support, expert advice and liaison for all School sponsored clinical research projects, in particular the facilitation of: project initiation, indemnity and risk assessment, regulatory registration and green-light under the UK trials regulations to ensure compliance prior to start of the study.

• Responsible for the administration of a large, diverse portfolio of study applications and projects. This involve liaison with staff within LSHTM to ensure receipt of the appropriate authorisations prior to study start.

• Ensuring monitoring and reporting arrangements are adhered to.

• Advising Investigators in developing research protocols in line with regulations.

• Providing advice and training to academics and administrators on clinical research governance and local procedures and assist the Quality and Governance Manager in addressing such issues. This includes undertaking a project to ensure that all material is added to the online e-learning system for the benefit of overseas staff and students.

• Maintaining knowledge of the legal, ethical (and funding) framework for research, in particular for clinical trials and projects involving human tissue, as well as the interpretations therein as they pertain to LSHTM’s research activity and the role of sponsor. This includes the production of regular newsletters and other e-bulletins.

• Assisting in the audit of clinical trials and other research within the School, and to deputise for the Quality and Governance Manager where appropriate.

• Assisting in the further development of the office and interacting with a wide range of stakeholders within the School

• Assisting the Quality and Governance Manager in collating data on School research activity. May 17 – July 18 Postgraduate Research Assistant in Molecular Virology University of Oxford applied to HIV infection

• Acting as the curator of samples received in Oxford for the RIVER and HEATHER clinical trials.

• Ensuring safe storage and database logging of these samples

• Undertaking the qPCR assays to quantify HIV DNA to be used as primary and secondary outcome measures for the study

• Presenting data and ideas at regular laboratory group meetings

• Participating in presenting the research results and preparing reports and publications necessary for the successful performance of the research

• Working independently and unsupervised

• Generating and keeping an updated record of all the experimental results

• Working co-operatively with senior and junior colleagues and sharing laboratory and research resources February 13 – April 17 Research Technician / Tissue coordinator Imperial College London

• Undertaking tasks in all aspects of the preparation and storage of tissue explants used in evaluation of mucosal immune responses in human and in NHPs

• Involved in the development, standardisation, optimisation and validations of new immunogenicity assays

• Fully trained to work in Category II and III laboratory, following standards of the Good Clinical Practise regulation

• Practical knowledge of storage, use and transportation of liquid nitrogen within college premises

• Proficient in various laboratory techniques including cell culture and tissue culture work, ELISA, ELISPOT, luminex, isolation of PBMC from HIV positive and negative samples

• Keeping records of all the findings and analysing research data

• Practical knowledge and understanding of multi-colour cytometry

• Delivering presentation in confidents style during lab meeting and journal clubs

• Attending group research meetings and internal seminars, workshops and conferences

• Outstanding people skills, having direct contact with research participants, medical and academic professionals

• Responsible for consenting patients undergoing hysterectomy for use of their tissue in research studies

• Collaborating with surgeons from different hospitals to obtain penile and rectal specimens used in our research projects

• Updating and verifying records in tissue database for the accurate tracking of the samples

• Managing multiple responsibilities, prioritising tasks, using my own initiative and working under pressure

• Supervising and training MSc and PhD students

• Participation in writing SOP’s and contributing to the scientific publication Publications:

• Fidler S, Stöhr W, Pace M, Dorrell L, Lever A, Pett S, Kinloch-de Loes S, Fox J, Clarke A, Nelson M, Thornhill J, Khan M, Fun A, Bandara M, Kelly D, Kopycinski J, Hanke T, Yang H, Bennett R, Johnson M, Howell B, Barnard R, Wu G, Kaye S, Wills M, Babiker A, Frater J; RIVER trial study group. Antiretroviral therapy alone versus antiretroviral therapy with a kick and kill approach, on measures of the HIV reservoir in participants with recent HIV infection (the RIVER trial): a phase 2, randomised trial. Lancet 2020 Mar 14;395(10227)

• Martin GE, Pace M, Shearer FM, Zilber E, Hurst J, Meyerowitz J, Thornhill JP, Lwanga J, Brown H, Robinson N, Hopkins E, Olejniczak N, Nwokolo N, Fox J, Fidler S, Willberg CB, Frater J. Level of Human Immunodeficiency Versus DNA Are Determined Before ART Initiation and Linked to CD8 T- Cell Activation and Memory Expansion. J Infect Dis 2020 Mar 16; 221(7)

• Thornhill JP, Pace M, Martin GE, Hoare J, Peake S, Herrera C, Phetsouphanh C, Meyerowitz J, Hopkins E, Brown H, Dunn P, Olejniczak N, Willberg C, Klenerman P, Goldin R, Fox J, Fidler S, Frater J; CHERUB investigators. CD32 expressing doublets in HIV- infected gut- associated lymphoid tissue are associated with a T follicular helper cell phenotype. Mucosal Immunol 2019 Sep 12(5)

• Martin GE, Pace M, Thornhill JP, Phetsouphanh C, Meyerowitz J, Gossez M, Brown H, Olejniczak N, Lwanga J, Ramjee G, Kaleebu P, Porter K, Willberg CB, Klenerman P, Nwokolo N, Fox J, Fidler S, Frater J. CD32- Expressing CD4 T Cells Are Phenotypically Diverse and Can Contain Proviral HIV DNA. Front immunol 2018 May 4 (9)

• Carolina Herrera, Naomi Armanasco, Javier García-Pérez, Paul Ziprin, Natalia Olejniczak, José Alcami, Jeremy Nuttall and Robin J. Shattock. Maraviroc and reverse transcriptase inhibitors combinations as potential pre-exposure prophylaxis candidates. AIDS 2016; 30(7).

• Hannah M. Cheeseman, Ann M. Carias, Abbey B. Evans, Natalia J. Olejniczak, Paul Ziprin, Deborah F. L. King, Thomas J. Hope, Robin J. Shattock. Expression profile of human Fc receptors in mucosal tissue: implications for antibody- dependent cellular effector functions targeting HIV-1 transmission. PLoS One 2016; 11(5).

• Hannah M. Cheeseman, Natalia J. Olejniczak, Paul M. Rogers, Abbey B. Evans, Deborah F.L. King, Paul Ziprin, Hua- Xin Liao, Barton F. Haynes, Robin J. Shattock. Broadly neutralising antibodies display superior potential over non-neutralising antibodies in preventing HIV-1 infection of mucosal tissue. Journal of Virology 2016 (01762-16) Had privilege to present our scientific achievements on international workshop in the Cape Town

‘Evaluation of anti-proteases as potential candidate microbicides’ Several publications indicate that not all individuals exposed to HIV-1 become infected. For example, evidence from studies in HIV-resistant women (exposed uninfected) from a Sex Worker cohort in Kenya suggests that mucosal immunological factors in the female genital tract are playing an important role. Resistant to HIV infection has also been seen in highly exposed MSM. Previous studies have correlated this resistance to HIV-1 infection with an entire set of proteins expressed in the cervicovaginal mucosa. These proteins include antiproteases such as serpins, mainly A1, A3, B1, B13, C1 and G1.Therefore, the major aim of our project was to assess the activity of a panel of antiproteases against HIV-1 in pre-clinical mucosal tissue explant models. October 12 – February 13 Volunteer in Professor Shattock’s laboratory Imperial College London

• Taking responsibility for the VLP-based HIV vaccine project

• Mastering molecular biology techniques, including cloning, PCR, gel electrophoresis, extraction of DNA and RNA, ligation, transformation, sequencing, cell transfection, western blotting and virus growth assay.

• Responsible for equipment calibration and maintenance

• Assisting in analysing data and preparing SOPs

• Maintaining general laboratory supplies

• Carried out own scientific work accurately and efficiently Feb 12 – Aug 12 MSc project Imperial College London Project: ‘Secondary structure based mutagenic analysis of 5’- end of MNV genomic RNA’ The aim of my project was to generate a panel of mutants in the 5’ end of the MNV genome. These mutations were designed to disrupt the secondary structure of 5’ end of MNV genome while avoiding any changes in amino acid sequence. After generation of these mutants I had to examine the effect of some of the mutants on viral growth. In case of any defect, future impact of mutation on host protein binding was evaluated.

Achievements:

• Successfully managed to accomplished my studies having full time work

• I directly approached Prof Shattock in regards to a volunteer placement within the group Education and qualifications

• Imperial College London, UK, (2011 – 2012)

MSc in Molecular Biology and Pathology of Viruses

• Adam Mickiewicz University, Poznan, Poland, (2003 - 2007) BSc in Human Biology

Transferable skills

• Communication skills: Excellent written, oral and presentation skills; able to write well and adapt writing style for different intended readerships; keep regular correspondence with co-researchers and colleagues; proven ability to explain complex information to a lay audience.

• Interpersonal skills: Able to work successfully within a team of professionals and with members of the public; wide exposure to people from other cultures and different ages and sections of society.

• Organisational skills: Ability to manage time efficiently and meet deadlines, keeping careful records; excellent project management skills.

• Information technology: Experienced at conducting literature searches (PubMed, Medline), managing electronic literature databases (Endnote), using word processing (Microsoft Word), maintaining spreadsheets and databases

(Microsoft Excel, Access), email and internet use; proficient touch-typist. Language skills Fluent in English and Polish, intermediate German

Contact this candidate