With ongoing and ground-breaking developments in Oncology and Rare Disease, an
increased focus on more scientific, targeted medicine and continuous integration
of technology into development and delivery of medicine, there has never been a
more exciting time to join us!
As a global leader we’re looking for a Senior Lead Clinical Research Associate
(CRA) to drive success as part of our Non-interventional Study team.
Join Oracle as a Lead CRA and make a real impact by guiding teams, ensuring
top-quality clinical research, and driving groundbreaking projects on a global
scale!
What you will do
As a Senior Lead Clinical Research Associate at Oracle, you will:
Drive study start-up: Develop feasibility questionnaires, identify and assess
potential study sites, and ensure proper site selection in close
collaboration with Project Managers and Sponsors.
Oversee contracts and budgets: Review and track site contracts and budgets
for study specifications, working closely with CRA and contracting teams, and
involve contract specialists for legal matters.
Ensure regulatory compliance: Coordinate with regulatory teams and CRAs to
ensure all ethical committee (EC) requirements are met and support the
preparation and submission of essential site documents.
Lead study site management: Supervise site activation and ongoing management,
including monitoring activities from feasibility to close-out, in line with
GCP, SOPs, study protocols, and plans.
Conduct Feasibility Assessments: Organize, identify and manage the
feasibility process with CRA's.
Train and coordinate CRAs: Oversee, mentor, and train a cross-country team of
Clinical Research Associates, develop project-specific training materials,
and ensure delivery of high-quality site management.
Monitor progress and quality: Create and maintain study trackers, monitor CRA
activities and site deliverables, identify and escalate critical issues, and
review/approve monitoring reports.
Foster team collaboration: Act as the key point of contact between the study
team, Sponsor, study sites, and CRAs, supporting strong working relationships
and continuous process improvement.
Travel for site initiations, closures or quality visits: Be available to
travel to clinical sites to train and monitor site activities as needed.
While there is no guaranteed travel, flexibility is required.
Required Experience
Education: Bachelor’s degree in Life Sciences, Medical Science, Pharmacy,
Public Health, or equivalent, with a minimum of three years’ hands-on
clinical research experience.
Clinical research expertise: At least 3 years of experience as a CRA,
including site initiation, Trial Master File (TMF) management, and site
monitoring for both clinical and non-interventional studies.
Communication skills: Outstanding spoken and written proficiency in English
(C1 level minimum). Additional languages are considered a strong asset.
Technical proficiency: Comfort with MS Office, EDC, CTMS experience and
willingness to learn and handle various technical systems and tools.
Personal qualities: Exceptional organizational and problem-solving skills,
strong cross-cultural
team work, initiative in process optimization, and the ability to manage
competing priorities in a fast-paced environment.
Financial management: Experience reviewing site contracts, budget and
invoices.
Attention to detail: Ability to work independently with careful, precise, and
thorough execution of complex tasks.
RESPONSIBILITIES
What you will do
As a Senior Lead Clinical Research Associate at Oracle, you will:
Drive study start-up: Develop feasibility questionnaires, identify and assess
potential study sites, and ensure proper site selection in close
collaboration with Project Managers and Sponsors.
Oversee contracts and budgets: Review and track site contracts and budgets
for study specifications, working closely with CRA and contracting teams, and
involve contract specialists for legal matters.
Ensure regulatory compliance: Coordinate with regulatory teams and CRAs to
ensure all ethical committee (EC) requirements are met and support the
preparation and submission of essential site documents.
Lead study site management: Supervise site activation and ongoing management,
including monitoring activities from feasibility to close-out, in line with
GCP, SOPs, study protocols, and plans.
Conduct Feasibility Assessments: Organize, identify and manage the
feasibility process with CRA's.
Train and coordinate CRAs: Oversee, mentor, and train a cross-country team of
Clinical Research Associates, develop project-specific training materials,
and ensure delivery of high-quality site management.
Monitor progress and quality: Create and maintain study trackers, monitor CRA
activities and site deliverables, identify and escalate critical issues, and
review/approve monitoring reports.
Foster team collaboration: Act as the key point of contact between the study
team, Sponsor, study sites, and CRAs, supporting strong working relationships
and continuous process improvement.
Travel for site initiations, closures or quality visits: Be available to
travel to clinical sites to train and monitor site activities as needed.
While there is no guaranteed travel, flexibility is required.
QUALIFICATIONS
Disclaimer:
Certain U.S. based or U.S. customer or client-facing roles may be required to
comply with applicable requirements, such as immunization/occupational health
mandates, and/or drug testing requirements.
Range and benefit information provided in this posting are specific to the
stated locations only
US: Hiring Range in USD from: $74,100 to $148,300 per annum. May be eligible for
bonus and equity.
Oracle maintains broad salary ranges for its roles in order to account for
variations in knowledge, skills, experience, market conditions and locations, as
well as reflect Oracle's differing products, industries and lines of business.
Candidates are typically placed into the range based on the preceding factors as
well as internal peer equity.
Oracle US offers a comprehensive benefits package which includes the following:
1. Medical, dental, and vision insurance, including expert medical opinion
2. Short term disability and long term disability
3. Life insurance and AD&D
4. Supplemental life insurance (Employee/Spouse/Child)
5. Health care and dependent care Flexible Spending Accounts
6. Pre-tax commuter and parking benefits
7. 401(k) Savings and Investment Plan with company match
8. Paid time off: Flexible Vacation is provided to all eligible employees
assigned to a salaried (non-overtime eligible) position. Accrued Vacation is
provided to all other employees eligible for vacation benefits. For employees
working at least 35 hours per week, the vacation accrual rate is 13 days
annually for the first three years of employment and 18 days annually for
subsequent years of employment. Vacation accrual is prorated for employees
working between 20 and 34 hours per week. Employees working fewer than 20 hours
per week are not eligible for vacation.
9. 11 paid holidays
10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes
each calendar year. Unused balance will carry over each year up to a maximum cap
of 112 hours.
11. Paid parental leave
12. Adoption assistance
13. Employee Stock Purchase Plan
14. Financial planning and group legal
15. Voluntary benefits including auto, homeowner and pet insurance
The role will generally accept applications for at least three calendar days
from the posting date or as long as the job remains posted.
Career Level - IC3
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insurance, and retirement options. We also encourage employees to give back to
their communities through our volunteer programs.
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employment process. If you require accessibility assistance or accommodation for
a disability at any point, let us know by emailing
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calling 1-888-404-2494 in the United States.
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will receive consideration for employment without regard to race, color,
religion, sex, national origin, sexual orientation, gender identity, disability
and protected veterans’ status, or any other characteristic protected by law.
Oracle will consider for employment qualified applicants with arrest and
conviction records pursuant to applicable law.