Senior Clinical Research Associate
In this role, you have the opportunity to
The Clinical Operations Senior Clinical Research Associate (CRA) is responsible for monitoring and leading the monitoring of clinical research studies involving human subjects from its inception to close-out according to budget and timelines.
You are responsible for
- Ensures that all internal and external collaborating staff are appropriately organized, trained and managed to execute the terms of a clinical project per protocol and to ensure study and data integrity in support of a broader Clinical Evidence Strategy.
- Produces work abiding by applicable Regulatory statutes (such as GCP) and withstanding scrutiny in the event of an audit.
- Actively interfaces with various internal and external stakeholders including Clinical and Medical Affairs Management and functional teams, internal customers, Regulatory, Legal, CRO/vendor staff, and clinical research staff.
- Qualifies, Selects, Trains and Monitors internal and external study Investigators and study documentation.
- Responsible for creating monitoring reports, follow-up documentation and ensuring updates in CTMS.
- Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
- Has extensive knowledge of multiple company products and services.
- Frequently interacts with subordinate supervisors and functional peer groups.
- Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules.
- May be the lead for site management and expected to communicate well with internal and external business partners including key opinion leaders.
- Works on issues where analysis of situation or data requires review of relevant factors.
- Exercises judgment within defined procedures and policies to determine appropriate action.
- Communicates externally with sites, vendors and internally with project teams, marketing, regulatory and R&D.
- Sensitive to ensuring communication is clear, concise and accurate with guidance from the Manager, Clinical Operations.
- Acts as advisor to unit or sub-units and may become actively involved, as required, to meet schedules and resolve problems.
- Independently monitors and may execute more complex clinical studies with guidance from Leader or Manager
- Strong influence on Business magnitude
- Typically acts as a lead, coordinating the work of Specialist or Coordinator, but is not a supervisor.
You are a part of
The Clinical and Scientific affairs team supporting clinical studies across Philips. This exciting opportunity ensures exposure to a multitude of indications, medical devices, and workflow solutions. This position works in partnership with R&D, marketing, regulatory, quality, and legal among other functional areas. This matrix organization approach will improve collaboration and your learning and development across a multitude of disciplines. This position will be responsible for ensuring all clinical studies for multiple projects are assigned to appropriate clinical staff, timelines and budget are met, and all deliverables completed per aligned project plans.
To succeed in this role, you should have the following skills and experience
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
- Bachelor or Masters in Science or Healthcare discipline
- 5+ years related experience in clinical studies (healthcare setting , CRO, medical device and/or pharmaceutical company and/or industry)
- At least 3 years of experience as a Clinical Research Associate monitoring clinical studies.
- Experience in using EDC and CTMS systems is desirable
- Knowledge of Sharepoint and Excel is helpful in this role
- Experience with direct line management of staff including hiring, training, oversight and mentoring
- Excellent verbal and written communications skills
- Excellent interpersonal and organizational skills
- A pro-active, committed and motivated attitude
- A demonstrated working knowledge of GCP, ICH guidelines, ISO Standards, FDA/EU regulations
- Excellent record-keeping skills; good documentation practice
- Ability to maintain excellent working relationships with a broad range of clinical study staff.
- Flexibility in work hours and readiness to travel; travel approximately 20%
In return, we offer you
We believe that every growth period creates an exceptional career runway. In fact, the Clinical and Scientific Affairs leadership team gets out of bed every morning with the sole focus of growing the business and growing the people who contribute to it. Luckily, you are the benefactor of this unique opportunity and leadership commitment- likely to experience an exciting high stakes, mobility-focused environment from which to create your own future – personally, professionally & financially.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
Equal Employment and Opportunity Employer/Disabled/Veteran
If you forgot your password, you can click the Forgot Password button on the Sign In screen to reset it.
If you have any other questions regarding the recruitment process please refer to our FAQs. In case of technical difficulties with the website, please send an email to firstname.lastname@example.org.
(Note: To ensure fairness and legal compliance in our recruitment processes, only technical issues will be monitored through the above inbox. Please do not submit resumes or applications to this email, as they will not be reviewed. Only applications received through the online application process will be considered.)