Associate Director- Clinical Trial Centre

South East
upto £65k per annum + benefits
10 Jan 2013
31 Jan 2013
DK-AD
Permanent


Job Title:     Associate Director, Clinical Trial Centre
Responsible for:  Senior Research Nurse; Senior Study Physician; Clinic Administration Manager; Site Laboratory Technician; Clinical Trial
Hours:  37.5 hour week
Required vaccinations:  Flu; Hep B 
 
Overall Job Purpose
Responsible for the profitable management of a given clinical trial
centre, consistent with division and company principles, strategies, and
objectives.  Reporting directly to the Clinical Site Management Director. The
position holder is accountable for the overall coordination, organisation, and
efficient implementation of clinical trials screening and follow up visit operations
and regulatory compliance at the  clinical trial centre.  Line manages
all site staff, working closely with Senior Study Physicians and Clinical Trial
Managers to ensure that all study-related procedures are completed properly
from a clinical and a regulatory perspective.  In executing these position
responsibilities, the Associate Director, Clinical Trial Centre is guided by Good
Clinical Practices (GCP), International Committee on Harmonization (ICH)
guidelines, and company standard operating procedures and policies. Performs
diverse responsibilities requiring considerable analysis, judgment, and detailed
understanding of clinical research processes. 
 
 Ideally you will be from an outpatient or assesment unit background, however this is not essential.
 
 
Key Roles and Responsibilities
Manages all aspects of clinical research studies and related office operations,
including:
General Site & Line Management
?  Hire, train, and manage the Senior Research Nurses Quality Control
Associates, Clinical Trial Managers, Senior Study Physicians and all
Administrative support staff within a given  Clinical Trial
Centre;
?  Indirectly manages other clinical and administrative staff and contractors
(e.g., subinvestigators, dieticians, etc.);
?  Develop and manages an administrative team who coordinate subject visit
booking;
?  Develop and manage a resourcing team who ensure adequate and
appropriate staffing are scheduled to accommodate fluctuating volume of
subject visits;  
 
?  Liaise with company central support services in finance, human
resources, IT, facilities management to ensure smooth local operations at
the Clinical Trial Centre;
?  Responsible for the collection, management, and maintenance of clinical
trial source documentation, including the transfer of medical files from the
Clinical Trial Centre to the VCM quarantine unit;
?  Manage trial budgets as it relates to subject screening and subject follow
up; maintains site related accounts;
?  Ensure that adequate procedures and processes are in place for sample
collection processing and transfer to company laboratories for analysis
and storage;
?  Build and maintain local relationships with GP surgeries such that access
to their patient population is achieved;
?  Establish and manage health & safety requirements at the Clinical Trial
Centre;
?  Assurance that personal and confidential information is restricted to those
entitled to know;
?  Serve  as  primary  key  holder  and  emergency  contact  for  Clinical  Trial
Centre; and
?  Serve as local host to sponsors, auditors and inspectors.
 
Trial Specific Site Operations
?  Responsible for ensuring compliance with regulations and ICH GCP,
company medical management protocols, SOPs and Operating
Instructions;
?  Manage the processes of subject appointment scheduling, informed
consent, subject visits, source document preparation, Case Report Form
and other document preparation and disposition, and regulatory
documentation and reporting;
?  Establish local procedures to ensure adherence to trial protocols and
administrative requirements, and ensures that central and core processes
are followed;
?  Oversee the compilation and maintenance of the local Site file, ensuring
required documents are transferred to the central office;
?  Responsible for the coordination of document transfer between
company offices, facilities, and sites; and
?  Establish weekly screening targets and monitors actual against prediction,
directing the staff to increase appointment availability as needed in order
to meet screening targets for given quarantine sessions.
 
This is a non-exhaustive list
 
 
 
Special Requirements
?  Employees have a particular  responsibility  for ensuring  the confidentiality
of personal information and company data.
 
?  All employees are bound to comply with all company policies and standard
operating procedures and are required to update themselves on a regular
basis and attend all mandatory training. 
 
?  To keep updated and maintain your CPD including attending
internal/external seminars/workshops etc.
 
Please note:  
This job description reflects the core activities of the role and as the company
and as the individual in this role develops there will inevitably be changes in
the emphasis of duties.  It is expected that the job holder will recognise this
and adopt a flexible approach to work and be willing to participate in training. 
 
Requirement  Essential  Desirable
Qualifications
B.A. or B.S. required,
advanced degree
preferred 

Competencies and skills
Understanding of Clinical
Research Requirements:  
Familiar with clinical
research study processes
and requirements. 
Understands regulatory
requirements, as well as
Good Clinical Practices
(GCP) and International
Conference on
Harmonization (ICH)
guidelines
   
Thoroughness and
Accuracy: 
Able to collect, organise,
interpret, and record
detailed information as
required by study
sponsors and regulatory
and review agencies
  
Communication:  
Able to communicate with
providers, co-workers,
sponsors, and others in a
collaborative and
courteous manner. 
Knowledgeable in medical
terminology so as to
communicate with
physician office and
laboratory staff

Management:  
Able to manage a staff of
clinical professionals and
create a productive,
satisfying work
environment
 
Experience
Progressive experience in
managing clinical trials
and/or experience in clinical research preferred 

For more information or an informal discussion, please contact Daniella Kent on 0161 245 4453.