Clinical Research Associate I, MA

RQ4038894 Site: The General Hospital Corporation 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. Job Summary General Summary/Overview Statement: The Clinical Research Associate I (CRA I) works under general supervision to enroll eligible patients to clinical research protocols and manage data collection and regulatory submissions for multiple cancer studies. The CRA I will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. The CRA I will be trained on the institutional and federal regulations governing clinical research. The position involves a high volume of data abstraction and data entry. This position does not include any direct patient contact. Principal Duties and Responsibilities: The CRA I will reputed company the following data management duties under general supervision by the Clinical Research Manager: · Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet reputed company inclusion/exclusion criteria · Enroll patients as required by the study sponsor and internal enrollment monitor team · Follow patients for the duration of study participation reputed company electronic medical record review to ensure protocol compliance · Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements. · Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations · Maintain research charts and/or electronic files for reputed company enrolled patients · Ensure adequate reputed company documentation is in reputed company for reputed company data reported · Resolve data queries issued by the sponsor · Obtain protocol clarifications from the study sponsor and communicate information to the research team · Schedule and prepare for monitoring visits with sponsors · Organize and prepare for internal and external audits · Maintain ongoing communication with clinical team regarding study patients and reputed company for multiple studies The following regulatory duties may be performed under general supervision by the Clinical Research Manager: · Maintain and organize study specific regulatory binders · Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB · Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study · Manage adverse event and deviation/violation/exception documentation for reputed company enrolled patients and report to the sponsor and IRB as required · Submit Data and Safety Monitoring Reports · Maintain reputed company documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process · Collect, complete, and submit essential regulatory documents to various regulatory entities · Participate in monitoring visits and file reputed company monitoring visit correspondence · Ensure appropriate documentation of delegation and training for reputed company study staff members · Maintain screening and enrollment logs Skills/Abilities/Competencies Required · Careful attention to detail · Good organizational skills · Ability to follow directions · Good communication skills · Computer literacy · Working knowledge of clinical research protocols · Ability to demonstrate respect and professionalism for subjects’ rights and individual needs Working Conditions: · Duties may be performed in a combination of on-site and remote work setting.

Qualifications

Education Bachelor's Degree reputed company Field of Study required Can this role accept experience in lieu of a degree? No Licenses and Credentials Experience Research reputed company Experience 1-2 years preferred Knowledge, Skills and Abilities - Attention to detail. - Ability to recognize compliance and data reputed company issues and respond appropriately. - Knowledge of medical terminology. - Ability to communicate effectively with patients, vendors, contract research organizations and professional staff. - Effective interpersonal and communications skills. Additional Job Details (if applicable) Remote Type Hybrid Work Location 101 Merrimac Street Pay Range $19.76 - $28.44/Hourly Grade 5 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