Clinical Research Director jobs in Lakeville, MN

OVERVIEW

We are currently searching for a skilled professional to join a well-known client's team as a remote Senior Clinical Research Associate. The Sr. CRA will focus on the oversight and monitoring of investigational sites to ensurecompliance and assist with study management activities. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES

• The Sr. CRA is responsible for assisting with the execution of high-quality clinical studies and will focus on the oversight and monitoring of investigational sites to ensure compliance and assist with study management activities.
• The Senior CRA will be a key contributor to the company's clinical department and primarily responsible for the site management of assigned clinical investigative sites.
• The Sr. CRA will assist with the implementation and execution of study protocols and associated study documents for clinical trials, including clinical monitoring of the organization study.
• This also includes the coordination of site activities from site start-up to site closure as needed.
• The Sr. CRA will participate as needed in study review meetings and attend scientific meetingsand industry conferences as required.
• The Sr. CRA will also conduct site visits including Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, and Close Out Visits.

  EXPERIENCE

• 5 years' experience as a CRA and 3 or more years of monitoring experience with medicaldevices trials.
• Experience in study start-up and oversight of a CRO is highly desired.
• Therapeutic experience in breast cancer, breast reconstruction, or breast aesthetics(preferred).
• Ability to travel, approximately 25-50% which may be more based on business need.
• Read, write, and speak fluent English; excellent verbal and written communication skills is a must, including presentation skills.
• Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations.
• Understanding of clinical trial management processes and systems, including monitoring, investigational product handling, data management, etc.
• Well-developed critical thinking skills, including but not limited to critical attitude, in-depth investigation for appropriate root cause analysis and decision-making.
• Ability to handle risk-based monitoring concepts and processes.
• Ability to maintain internal and external stakeholder focus through the utilization of good listening skills, attention to detail and the ability to perceive underlying issues.
• Effective social skills and professional demeanor and appearance
• Strong attention to detail

EDUCATION

Bachelor's Degree or higher in a healthcare or science related field. Consideration of acandidate with any alternate level of education will be case dependent based on

experience and positional need.

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.