Sr Clinical Research Associate
United States of America - Remote Based
Job Title
Sr Clinical Research AssociateJob Description
Senior Clinical Research Associate
The Senior Clinical Research Associate (CRA) actively drives the execution of clinical trials in accordance with applicable regulatory standards and company requirements. Senior CRAs ensure adherence to the protocol, corporate objectives, regulatory compliance, and professional integrity for our internal and external stakeholders.
Your role:
- Work closely with the Project Manager to execute the successful conduct of assigned studies consistent with the processes and procedures, clinical strategy, project plans, and protocol. Preparation of study related material and training materials.
- Manage the monitoring (Qualification, Initiation, Interim and Closeout) of investigational sites to ensure study requirements are being fulfilled. Facilitate and conduct training of investigators, site staff, and study team. Establish and maintain productive relationships with site personnel.
- Work with Project Manager to develop, update and improve study plans per processes. Review and verify adequacy of regulatory and site management documentation.
- Work with study team to ensure sites comply with study protocol and regulations, queries and document requests are created and addressed in an accurate and timely manner and required study documents are submitted and filed appropriately. Provide input to study budgets, documented processes and project trackers. Share lessons learned and mentor team members.
- Oversee the organization of the Trial Master File and Site Files. May perform audits of monitoring, site files, etc.
You're the right fit if:
- You’ve acquired 10+ years of experience in clinical research with experience working directly with research studies in a healthcare setting and/or supporting clinical research and monitoring medical device trials with a sponsor or CRO, preferably working with PCI studies and Philips coronary technology (preferred).
- Your skills include knowledge and experience working with ISO 14155, experience facilitating large scale study meetings required. Experience with Serious Adverse Event (SAE) reporting is preferred but not required.
- You have a bachelor’s degree or higher in a scientific area.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
- You’re an excellent communicator with an ability to work well cross functionally, and in a complex global working environment. The ideal candidate will be in Central Time Zone to best align with key stakeholder time zones. This role requires up to 70% travel to clinical trial sites based on business needs.
How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
This is a field-based role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
- Learn more about our business.
- Discover our rich and exciting history.
- Learn more about our purpose.
- Learn more about our culture.
Philips Transparency Details
The pay range for this position in AZ, AR, ID, IA, KS, KY, LA, ME, MS, MO, MT, NE, NM, OK, SC, SD, TN, UT, and WV are $96,188 to $153,900.
The pay range for this position in AL, CO, FL, GA, IL, IN, MI, MN, NV, NH, NC, ND, OH, OR, PA, TX, VT, VA, WI, and WY are $101,250 to $162,000.
The pay range for this position in AK, DE, HI, MD, RI, and WA is $106,313 to $170,100.
The pay range for this position in CA, CT, MA, NJ, NY, DC, is $113,400 to $181,440.
The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.
At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
Additional Information
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
ApplyJob Profile
Field-based role Not fully remote Onsite roles require full-time presence Requires travel US work authorization
Benefits/Perks401k up to 7% match Annual Incentive Bonus Education reimbursement Flexible hours Generous PTO Health technology company HSA HSA with company contribution Incentives Long-term incentives PTO Remote work Sales commission Stock Purchase Plan Training Travel opportunities
Tasks- Develop study plans
- Ensure regulatory compliance
- Execute clinical trials
- Manage site monitoring
- Mentor team members
- Regulatory Compliance
- Training
- Train site staff
Adverse event reporting Clinical Clinical Research Clinical Strategy Clinical trials Communication Compliance CT Documentation Education Environmental Healthcare Health Technology ISO 14155 IT Medical device Office OR Organization Project Management Regulatory Compliance Relationship Management Reporting Research Sales Site Management Strategy Teams Technology Training Travel
Experience10 years
EducationBachelor Bachelor's degree Business Clinical Degree DO Higher Degree IT MA Master Medical MS Sales
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9