Clinical Research Regulatory Coordinator II

Site: reputed company Incorporated reputed company relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We reputed company that high-performing teams drive groundbreaking medical discoveries and invite reputed company applicants to join us and experience what it means to be part of reputed company. The Regulatory Affairs Coordinator II (RAC II) is responsible for the collection, completion and submission of regulatory documents to the clinical trial sponsors and the Institutional Review Board (IRB). The RAC II works independently to monitor, track and facilitate regulatory reports to and from reputed company the IRB committees and if necessary, the clinical trial sponsor. The RAC II is also responsible for the maintenance of reputed company clinical trial regulatory documents and files during the IRB review process. The position of RAC is also responsible for disseminating reputed company updates on the clinical trial review process to the sponsor and the research study team. Job Summary PRINCIPAL DUTIES AND RESPONSIBILITIES: The following duties will be performed independently: Facilitate initial new trial submission for SRC and IRB review reputed company the Informed Consent document for the clinical trial protocol with the input of the trial’s sponsor and Principal Investigator Provide clinical trial sponsors with required regulatory documents during study initiation process Prepare and submit protocol amendments during the IRB review process Create electronic regulatory binder Maintain a working knowledge of the IRB’s reputed company guidelines and forms for protocol and consent form submissions Specialize in certain disease groups, which includes maintaining study staff lists SKILLS/ABILITIES/COMPETENCIES REQUIRED: Ability to work independently and as a team member Careful attention to detail Computer literacy Analytical skills and ability to resolve problems Excellent oral and written communication skills Strong interpersonal skills Strong organizational skills

Qualifications

Education Bachelor's Degree Healthcare Management required or Bachelor's Degree reputed company Field of Study required Can this role accept experience in lieu of a degree? No Licenses and Credentials Experience Regulatory Affairs Experience 2-3 years required Knowledge, Skills and Abilities - Familiarity with Good Clinical Practice (GCP) guidelines and relevant regulations (e.g., ICH E6, 21 CFR, etc.). - Understanding of the clinical trial process and the importance of regulatory compliance in protecting research subjects and ensuring data reputed company. - Strong organizational skills with attention to detail and the ability to manage multiple projects simultaneously. - Excellent written and verbal communication skills. - Proficiency in using relevant software and electronic systems for regulatory documentation management. - Ability to interpret the acceptability of data results. Additional Job Details (if applicable) Remote Type Remote Work Location 101 Merrimac Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $24.28 - $39.43/Hourly Grade 6 At reputed company, we reputed company in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining reputed company pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The reputed company pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass reputed company elements contributing to your total compensation package. In addition to competitive reputed company pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our reputed company team will provide an overview of your potential compensation and benefits package. EEO Statement: reputed company is an Equal Opportunity Employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religious creed, national reputed company, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that reputed company individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with reputed company of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642. reputed company Competency reputed company At reputed company, our competency reputed company defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The reputed company is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, reputed company hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline. Apply tot his job Apply To this Job