Clinical Research Associate I (Trials Monitor) - Hybrid/Remote

POSITION SUMMARY: The Clinical Research Associate (CRA) will ensure site compliance to study-related activities for transplant and/or cellular therapy clinical trial protocols. The CRA will be responsible for ensuring site compliance including adherence to ICH/GCP regulatory guidelines/ethical principles and other applicable regulatory requirements. The CRA will be expected to perform site visits to complete source document verification and query issuance/management. The CRA will collaborate with supporting functional teams, as needed. Additionally, the CRA will be expected to serve as a resource and research liaison between sites and Sponsor representatives, as applicable, according to NMDP/Be The Match/CIBMTR standard operating procedures and best practices. This position can be remote (US) or hybrid. Check out our video Saving Lives: It's the Best Job Ever ACCOUNTABILITIES: This role ensures compliance with clinical trial protocols based on ICH/GCP regulatory guidelines/ethical principles, NDMP/Be The Match standard operating procedures and other applicable regulatory requirements. Conducts onsite or remote site visits to perform source document verification of critical data points and review of essential regulatory documents. Identify and escalate communication of site visit findings with site study personnel and other study designees. With oversight and guidance, analyzes trends in identified issues and authors visit reports and letters. Ensures documentation and resolution of identified issues and implementation of corrective and preventative action. Visit reports should document findings, action items and point of contact for escalation of non-compliance and data discrepancies to appropriate parties until resolution. Communicates with sites to schedule and conduct site visits per standard operating procedures and/or study-specific plans. Authors site visit reports to document findings, action items and point of contact for escalation of non-compliance and data discrepancies to appropriate parties until resolution. Provides clear and technically accurate information, both orally and in writing. Work with other functional groups to design study documents and processes for active study protocols. Assists in the development and testing of electronic data capture (EDC) systems, clinical trial management systems (CTMS), and other applications, as required. Complete and maintain all training requirements. Other duties as assigned. REQUIRED QUALIFICATIONS: Knowledge of: Clinical research study processes, study design, protocol management and ICH/ GCP research guidelines and ethical principles. Medical terminology and anatomy/physiology. Computer proficiency, including the use of standard software (word processing, databases, e-mail) and the use of Internet. Training and conflict resolution skills. Time management skills and problem-solving abilities. Ability to: High attention to detail with strong written and oral communication skills. Communicate clearly and effectively to site personnel through oral and written formats. Manage multiple deadlines and priorities, while ensuring quality and timeliness. Work effectively and efficiently for collaborative and independent tasks with site personnel and Sponsor. Onsite and remote site visit activity. Expect to travel 50 - 70% of time (domestic and international) to sites, as necessary. Must exemplify our NMDP/Be The Match Values in a highly professional manner in all settings. Education and/or Experience: Bachelor's degree in healthcare/science related field. Minimum three years' experience of conducting clinical research studies according to GCDMP / ICH GCP / FDA guidelines and/or verifying clinical data from medical records. NMDP/Be The Match values its employees. At one year, the employee may be considered for best suited opportunities within the organization that align with professional development and performance in current role. PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration) Clinical and/or research experience. Ability to acquire knowledge across multiple therapeutic areas inclusive of blood and marrow transplant field. Knowledge of medical and clinical research terminology. ACRP or SOCRA certification. Proof of being up-to-date on COVID-19 vaccination, including a booster when eligible, with acceptable documentation is required for employment. NMDP will consider all requests for medical or religious accommodation. Additional Information Number of Openings: 2 Pay Basis: Yearly Schedule: Full-time Driver Policy: No