Clinical Research Associate II- Fetal Research

About Children's Minnesota Children's Minnesota is one of the largest pediatric health systems in the United States and the only health system in Minnesota to provide care exclusively to children, from before birth through young adulthood. An independent and not-for-profit system since 1924, Children's Minnesota is one system serving kids throughout the Upper Midwest at two free-standing hospitals, nine primary care clinics, multiple specialty clinics and seven rehabilitation sites. As The Kids Experts in our region, Children's Minnesota is regularly ranked by U.S. News & World Report as a top children's hospital. Find us on Facebook @childrensminnesota or on Twitter and Instagram @childrensmn. Please visit childrensMN.org . Children's Minnesota is proud to be recognized by Modern Healthcare as one of 2023's Top Diversity Leaders. The national honor recognizes the top diverse healthcare executives and organizations influencing public policy, care delivery, and promoting diversity, equity and inclusion in their organizations and the industry. Department Overview At the Midwest Fetal Care Center (MWFCC), our team of expert physicians, scientists, and research staff are dedicated to becoming a research program that studies the most challenging problems in fetal healthcare and uses these insights to improve clinical practice. Research initiatives include investigator-initiated research studies as well as clinical trials and collaborative projects with the wider fetal therapy and cardiology community. Position Summary The role of the Clinical Research Associate II is to support investigators at the MWFCC in academic and industry clinical research projects, from study development through data summary and dissemination. This role assists with patient screening, consenting, data collection and extraction, database management, as well as regulatory tasks. This role will also assist with outcome tracking and reporting for fetal programs for quality improvement, program evaluation, and marketing and outreach initiatives. Responsibilities include but are not limited to the following: * Collaborate with the research team in designing research studies and assist with interpreting study results * Coordinate study startup, implementation, and closeout activities including site visit oversight scheduling space, staff, and necessary resources * Ensure compliance with protocols and overall clinical research objectives * Prepare regulatory and compliance submissions to the Institutional Review Board(IRB) and oversight committees and maintain compliance with all federal and local agencies in accordance with Good Clinical Practice guidelines * Interact with patients and families for securing informed consent, scheduling research visits, and collection of data, * Maintain documentation for regulatory binder, adverse event reporting, and communications between sponsors and sites * Other special skills specific to assigned research area may include phlebotomy, ECGs, sample collection, processing or shipping, chart abstraction or other duties as assigned * Manage personal career development and administrative tasks Baccalaureate degree or equivalent and at least two years of relevant clinical research experience in a similar or related field. Candidates must have: * Detail oriented with strong written and oral communication skills * Strong computer skills beyond basic familiarity with the most common hardware and software systems; * Have the ability to assist staff working on multiple projects; and organize and prioritize work effectively in order to meet deadlines. * Have experience working with pediatric populations (preferred) * SoCRA or ACRP certification preferred. Promotion to next higher level, typically Clinical Research Coordinator (CRC), is determined by the Clinical Research Program Manager through performance reviews that take into account both experience carrying out the department's job-related duties/tasks, as well as a demonstrated com itment to professionalism in carrying out those tasks in line with Children's values and organizational policies and procedures. Physical Demands Please click here to view the Physical Demands The posted salary represents a market competitive range based on salary survey benchmark data for similar roles in the local or national market. When determining individual pay rates, we carefully consider a wide range of factors including but not limited to market indicators for the specific role, the skills, education, training, credentials and experience of the candidate, internal equity and organizational needs. In addition to your salary, this position may be eligible for medical, dental, vision, retirement, and other fringe benefits. Positions that require night, weekend or on-call work may be eligible for shift differentials or premium pay. All job offers are contingent upon successful completion of an occupational health assessment, drug screen, background investigation, and compliance with the U.S. Government Form I-9, Employment Eligibility Verification. Children's Minnesota is proud to be an equal opportunity employer whose staff is representative of its community and considers qualified applicants for open positions without regard to race, color, creed, sex, religion, national origin, sexual orientation, genetic information, gender identity or expression, age, veteran status, disability, pregnancy, citizenship status, or any other characteristic protected under applicable federal, state, or local law.