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1+ months

Senior Clinical Research Associate

Kelly Services
Exton, PA 19341
**Senior CRA**



Exton, PA (Remote - local travel required)



8 month contract




**POSITION SUMMARY:**

The Sr. Clinical Research Associate (Sr. CRA) manages study activity from site selection, start-up, to close-out with adherence to regulations, maintaining data integrity, and aligning deliverables with corporate goals. As a key contributor to the Clinical Affairs team, this position develops and assesses SOPs, assesses processes for efficiency and compliance, and mentors other junior CRAs. This position requires the ability to be detailed-oriented, organized, and productive with a keen interest in medical device research.


**PRINCIPAL RESPONSIBILITIES:**




+ Independently manage all phases of a clinical study including protocol and CRF development, essential document management, contract execution, IRB/EC support, recruitment, site payment reconciliation and development of site tools.

+ Conducts Qualification, Site Initiation, Interim, and Close-Out monitoring visits to ensure adherence to monitoring plan, protocol, and regulations.

+ Train site personnel regarding the protocol and applicable regulatory requirements.

+ Ensure each site is meeting its goals of follow-up rate, data clean deadlines, protocol compliance, and enrollment.

+ Lead study meetings to ensure completion of established project team goals and objectives, including study training and data review.

+ Facilitate corrective action assessment and maintain TMF in BIMO readiness.

+ Provide study status updates to Management team and develop sufficient resolution of identified action items.

+ Contribute to annual reports, data management, data analysis, and publication support.

+ Maintain current knowledge of applicable US and international clinical regulations and guidance documents.

+ Participate in department systems and development initiatives including related trainings.

+ Support investigator meetings as needed.

+ Ensure CTMS is current and capable of generating reports upon request.

+ Support Protocol Deviation and Adverse Event review and reporting.

+ Maintain credentialing requirements at hospitals and clinics as needed.

+ Complete projects and tasks consistent with corporate objectives.

+ Support the Clinical Affairs team in general and with various improvement projects.

+ Perform other duties as assigned.

+ Contribute to the company culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun!







**EDUCATION / EXPERIENCE REQUIREMENTS:**






+ Bachelor of Science degree preferably in natural sciences or related field, or related practical experience.

+ At least 7 years of clinical research experience is **required** preferably in medical devices.

+ US IDE and OUS experience required, post-market study experience is **required** .

+ Experience managing all phases of a clinical study including protocol and CRF development, essential document management, contract execution, IRB/EC support, recruitment, site payment reconciliation and development of site tools is **required** .

+ Knowledge of interventional and cardiovascular disease state or willingness to undergo rigorous and fast learning independently.

+ Ability to foresee and prevent risks and understand when to elevate issues to management and recommend corrective action.

+ Excellent time management skills.

+ Ability to recognize potential obstacles and develop solutions to resolve them with minimal consequence within set timelines or change direction if priorities are modified.

+ Ability to make critical, independent decisions and be accountable for actions within a fast-moving environment.

+ Ability to perform at high-levels with limited supervision and effectively partner with team members when necessary.

+ Ability to exercise critical thinking skills in selecting methods, techniques, and evaluation criteria.

+ Proficient in Microsoft Word, Excel, and Access and the ability to quickly learn other software tools and applications.

+ Ability to develop strong relationships with investigative sites.

+ Ability to travel approximately 20-75% to perform training and monitoring. NOTE-COVID-19 may limit this

+ Valid drivers license issued by the state in which the individual resides.





**SPECIALIZED SKILLS & OTHER REQUIREMENTS** :




+ Responsible for performing all duties in compliance with FDAs Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements

+ Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.

+ Math Skills: Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

+ Analytical and Reading Skills: Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings.
Employee is regularly required to drive to customer sites and is exposed to outside weather conditions; close, distance, and peripheral vision are required along with the ability to adjust focus and depth perception Exposure to noise level may be high. (COVID-19 may limit this)
Requires regular presence in a (clinical or engineering or animal) laboratory setting where protective equipment or other health and safety measures and training are required to protect against chemical, biological or other hazards. Noise levels may be high.




**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2020-09-23 Expires: 2020-11-23

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Senior Clinical Research Associate

Kelly Services
Exton, PA 19341

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