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Clinical Research Careers
with KRGI accross
the
United States
REGIONAL
CLINICAL RESEARCH ASSOCIATES
We
are looking for clinical research associates regionally in
order to reduce costs of upcoming surgical
randomized trial across 11 centers in
the
United States
. It is a part of a lager trial involving 500 patients
across approximately 25 centers in United States, Canada and
and Europe. The industry sponsor wishes to
use this trial for an IDE (Food and Drug Admin)application
for their device.
Qualifications:
B.Sc. minimum.
At least two years of on-site monitoring experience
Good organization and time-management skills
Good problem solving skills
Excellent written and verbal communication skills
Attention to detail
Ability to work independently and in a team environment
Knowledge of GCP/ICH guidelines and the clinical trials
process
Please
apply if you are located in reasonable proximity to the
following clinical research sites where this clinical trial
is planned to take place:
Wakeforest School of Medicine, North Carolina
University if Michigan, Ann Arbor, Michigan
University of Pittsburg, Pittsburg, Pennsylvania
Greenville Hospital System, Greenville, South Carolina
UC Davis School of Medicine, Sacramento, CA
Carolina Medical Centres, Charlotte, NC;
Erie County Medical Centre, Buffalo, NY
Orthopedic Trauma Associates of North Texas, Dallas,
TX:
University of California, San Francisco, CA;
University of Indiana, Bloomington, IN
Harborview Medical Centre, Seattle, WA.
Qualified candidates who wish to expand their horizons with
a global CRO may send their CV to hr@krgi.org
for consideration.
CLINICAL
RESEARCH ASSOCIATES
IN
massachusetts AND
MARYLAND
We
are looking for clinical research associates for
upcoming clinical trial on behalf of the sponsor - a
leading developer of solutions for the ophthalmic
industry that enables doctors to offer their patients a simple examination for early detection and monitoring of AMD.
Qualifications:
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The clinical research associate
will monitor activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study
protocol.
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Review regulatory documents as required and prepare site visit reports.
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Must work both independently and in a team environment.
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May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing informed consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training.
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Prefer B.S./B.A. and
2 years monitoring experience.
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Customer service orientation.
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Sound knowledge of
GCP, medical terminology and clinical monitoring process.
Please contact:
hr@krgi.org
CLINICAL
RESEARCH ASSOCIATES
FOR
PHASE II BREAST CANCER TRIAL
We
are looking for clinical research associates accross
the United States for upcoming study of
investigational medical device for early detection of
breast cancer.
Requirements:
- Minimum of 2-3 years as a field
monitor or 4-5 years as a study coordinator
- R.N. or B.S./B.A.,
nursing/pharmacy/science
- Sound knowledge of
GCP
- Knowledge of the drug
development process
- Must be a team player
Responsibilities:
- Conducts trial initiation
- Perform on-site monitoring
- Perform clinical closeouts
- Participate in field monitoring
training
Please
submit your resume to hr@krgi.org
CLINICAL
DATA MANAGER
FOR
PHASE II BREAST CANCER TRIAL
Clinical Data
Manager is needed for
upcoming study of investigational medical
device for early detection of breast cancer.
Responsibilities
Responsible for in house clinical data management (CDM) production work including:
- CRF design, database design, data entry/verification
- Query processing, including creation and resolution of routine and complex
queries
- Project management for CDM tasks for clinical trials
- Manage CDM activities for outsourced studies
- Writes and/or review clinical trial documentation including
the data management plan.
Review protocols and SOPs and provide feedback to the clinical trial team
Requirements
- B.S./B.A., preferably in the life sciences or related discipline; years of experience may substitute for degree
- Two plus years experience in data management
- Working knowledge of at least one relational database such as Clintrial required
- Proficient with programming language e.g. PL/SQL, SQLPlus, SAS
- Proven project management skills
- Experience performing CDM activities associated with study start-up, maintenance and closeout
- Familiarity with the drug development process and experience with all phases of clinical development across multiple indications (e.g., phase I, II, III, international)
- Sound knowledge of
GCP, medical terminology and good data management
practices..
For immediate consideration please e-mail your CV to
hr@krgi.org
PROJECT MANAGER
FOR SURGICAL CLINICAL TRIAL
We
are looking for project manager for
upcoming surgical randomized trial across 11
centers in
the
United States
. It is a part of a lager trial involving 500 patients
across approximately 25 centers in United States,
Canada and and Europe. The industry
sponsor wishes to use this trial for an IDE
application with Food and Drug Administration
for their device.
Description
- Oversee the execution of all
assigned patient recruitment programs. Areas of
responsibility will include development of
appropriate media materials
- Responsible for day-to-day
project tracking-related activities associated
with trial recruitment and retention programs,
including: Working with production and design
staff to implement tasks in completing a job, work
with clients on obtaining approvals, and ability
to develop work plans.
- Responsible for the tracking
and reporting of program metrics, management of
the project timelines and budget, and review of
patient recruitment proposals.
- Act as primary liaison
between the CRO and sponsor
- Research and write materials
targeted at various audiences, including patients,
consumers, health care providers, sales reps and
payers.
- Manage complex projects from
concept through final presentation.
- Work on a broad range of
clinical research projects involving protocol
feasibility, patient recruitment, clinical trial
evaluation, and quantitative research.
- Write proposals and develop
presentation handout materials for new business -
specifically patient recruitment programs for
clinical trials.
Required skills
- Research experience in
healthcare or pharmaceutical industry.
- Demonstrated centralized
patient recruitment experience, including
management of associated media (e.g., TV, radio,
newspaper, etc.).
- Strong understanding of
clinical trial process (design and conduct) across
phases II-IV and how patient recruitment fits
within the process.
- Ability to understand
clinical protocols and associated study
specifications and develop effective patient
recruitment programs accordingly.
- Demonstrated understanding of
IRB submission and review processes. Proven
ability to manage several projects simultaneously.
- Strong quantitative
abilities.
- Strong oral and written
communication skills and the ability to present at
client meetings.
- Knowledge of the Internet and
other resources for conducting research.
- Proven ability to provide
accurate budgeting/cost projections.
- Excellent project management
skills.
- A team-oriented personality
with the initiative to accomplish goals.
Education and experience
- Bachelor's degree and minimum
5 years experience working in a patient
recruitment, clinical trial and/or advertising
environment.
- Minimum of 3 years project
management experience or an equivalent combination
of education and experience that gives the
individual the necessary knowledge, skills and
abilities to do the job.
- Experience developing
effective patient-oriented educational,
promotional and public relations programs
including patient print and multi-media materials,
advertising campaigns, client events, and other
industry-related activities.
Travel
- Some travel - client
meetings, visit investigative sites,, etc.
Additional requirements
- Word/Excel/PowerPoint/Database
skills essential.
For immediate consideration please e-mail your CV
to hr@krgi.org
QUALITY
ASSURANCE OFFICER
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We
are seeking the quality assurance
specialists and consultants. Qualified
candidates must possess a minimum of two
years experience quality assurance and
supervisory experience. This position
will be responsible for management of
quality assurance operations in clinical
research projects, review of SOP-s,
development of training materials,
coordination and management of phase
II-IV clinical research trials.
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The
quality assurance specialist
role/functions will include:
· Set up and maintanance of quality
assurance systems. Work closely with all
department managers and directors,
including regulatory affairs/quality
assurance, clinical data management,
biostatistics, medical writing, and
information technology.
· Oversee training and standard
operating procedures/working practices.
The ideal candidate will possess
Bachelor's degree in a science or
health-related field (Master's
preferred), minimum of two years quality
assurance or management
experience within a clinical research
organization or pharmaceutical company
environment. Experience with MS Office ,
excellent organizational, interpersonal,
communication skills and ICH GCP, GMP
and GLP knowledge are a must!
Please
contact:
hr@krgi.org |
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LIFE
SCIENCES GRADUATES FOR POSITIONS OF SCIENTIFIC
ADVISOR / REVIEWER / RESEARCHER
The
ideal candidate will possess Bachelor's degree
in the life sciences or health-related field
(Master's preferred).
Experience
with MS Office, excellent organizational,
interpersonal, communication skills and ICH
GCP knowledge are a must! ( GCP Training for
qualified candidates is available.)
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As
Scientific
Advisor / Reviewer / Researcher, your
duties and obligations will include proof
reading of existing training materials,
scientific writing, references search, working
on SOP-s, providing instructions to KRC on-line
students (if required) based on the GCP, GLP,
GMP training materials, supervising of other
scientific / research team employees (when
applicable). Clarification
of requirements with potential clinical research
client. Participation in clinical research
project planning activities. Working in close
cooperation with director of Clinical research
and the clinical research team. Cooperation with
clinical research / training teams from KRC
World Wide locations. Reporting of key stages of
the projects to top management. Evaluation of
GCP standards compliance in KRC SOP-s and other
documentation, Working on RFP-s (requests for
proposals) for new clinical research projects,
involvement in obtaining new clinical research
projects, protocol approvals, regulatory
approvals, appointment of CRA-s, cooperating
with external suppliers: CRF printing, CRO-s,
investigative drugs manufacturing, bulk, placebo
manufacturing, drug packaging, central
laboratory, contract biometrics. Estimating of
study budgets and other budgets. Participation
and monitoring research projects until
completion. Preparation of seminars,
presentations, and conferences.
Please
contact:
hr@krgi.org
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