The role of Project Manager is key to the successful running of volunteer studies at Cutest. The main responsibility is to oversee each study from its initiation to the final report stage and to ensure that the correct procedures and practices associated with the study are implemented.
i) General Duties:
a) Preparation of study specific protocols based on templates of standard studies carried out by Cutest. This will involve liaison with the study sponsors in order to develop a final version of the protocol that is agreed by both parties and is a working document for the Study Nurses.
b) Submission of the study protocol to the ethics committee for approval according to the Standard Operating Procedure (SOP) developed by Cutest.
c) Preparation of study specific Case Record/Report Forms (CRFs) based on templates of existing CRFs used by Cutest. This may involve liaison with the study sponsors and also the Study Nurses in order to develop a final working document for use by the Study Nurses.
d) Ensure that the study materials are available for the study start and to ensure that they are correctly labelled and stored and in accordance with the study protocol.
e) Liaise with the Study Nurses in terms of the scheduling and execution of studies. No formal claim of Good Clinical Practice (GCP) compliance is normally required for cosmetic studies. However, the practices and procedures generally adopted during the conduct of the studies at Cutest are consistent with the principles of ICH GCP and it is the responsibility of the Project Manager to ensure that this is so.
f) Ensure that the data generated during the course of a study is accurately transferred to the final study report by the secretarial staff.
g) Prepare reports with the assistance of the secretarial staff that summarises the study results based on templates of existing reports used by Cutest.
h) Ensure that invoices associated with study activities are prepared by the secretarial staff and forwarded to the sponsor.
ii) Other Duties:
a) Maintaining the archive storage of study documents
b) Assisting with studies where measurement techniques specific to the skin are needed. In this situation, specific training in the use of individual instruments will be given.
c) Ordering consumables used in the course of clinical studies (
d) Keeping the company SOPs up to date
e) Ensuring that COSHH assessments are carried out annually
f) Booking study days and arranging internal training for the nursing staff
g) Attending trade shows with the directors of Cutest or accompanying the directors on visits to existing or potential customers.
h) Actively taking part in meetings held at Cutest with existing or potential customers.
A Level or graduate qualifications with science background
Project management experience desirable but not essential
Experience of clinical research with human volunteers would be an advantage
Good interpersonal skills as will be working closely with volunteer members of the public
Organized, detail conscious and quality minded to support our international clients expectations