The Alliance for Clinical Trials in Oncology Foundation (Foundation) is a foundation created to enhance and expand the ability of the Alliance for Clinical Trials in Oncology (Alliance) to conduct cancer clinical research and address important treatment questions through large-scale clinical trials. Through efforts of the Foundation in support of the Alliance, clinical trials and laboratory research are conducted to discover new or improved ways to prevent, treat, and cure many types of cancer, including leukemia and lymphoma, and cancers of the breast, prostate, lung, and gastrointestinal (GI) tract, and help educate the medical community on methods of cancer diagnosis, treatment, and prevention. In May 2014, the Foundation created the Alliance Foundation Trials, LLC (AFT), respectively, a wholly-owned subsidiary of the Foundation. AFT was also created to conduct cancer clinical research and address medical care and treatment through large-scale clinical trials involving various industry-related partners. The Alliance Foundation Trials (AFT) is seeking a Clinical Research Associate (CRA) to support the management and execution of clinical trial operations across AFT studies. This role is responsible for key site management and study start-up activities, including feasibility assessments, site selection support, maintenance of trial master files (e TMF), and oversight of clinical trial systems such as CTMS. The CRA will collaborate closely with CROs, vendors, and investigative sites to ensure studies are conducted in compliance with ICH GCP guidelines and organizational standards, while supporting studies from start-up through ongoing maintenance. Come join an organization full of passionate, team-oriented professionals driven to change the face of cancer. Benefits of working at the Alliance for Clinical Trials in Oncology Foundation:8 weeks of paid time off (including PTO, sick, and holidays) during year one Medical, Dental & Vision plans with a 100% employer-paid option for employees Tuition reimbursement stipends Continuing Education3% employer match for retirement investments Annual Employee Performance Bonus Program Annual Cost of Living Adjustment50% commuter reimbursement Healthy Work/Life balance and flexibility ROLE AND RESPONSIBILITIESAssist operations team in supporting the Alliance member sites and elevate site related issues when necessary. Send, track, and review study-specific and global feasibility questionnaires. Assist with site selection and recruitment by generating site identification reports (e.g., site accrual); collecting, reviewing and tracking site feasibility/credentialing documentation and following up on site accruals accordingly. Track training information and issue trainings for sites and contacts. Collection of essential documents related to study start-up and review IP release packages. Prepare for and execute Investigator meetings and other site training programs. Assist with creation of start-up plans and templates. Ensure proper and timely filing of all relevant study documents into the e TMF on an ongoing basis to ensure compliance with applicable work instructions, SOPs, ICH GCP guidelines and AFT expectations. Perform routine review of filing procedures to ensure adherence to current quality guidelines at all times. Accurately enter and manage data within the Clinical Trial Management System (CTMS) by tracking completed training information that could carry over to other studies; maintaining site information and rosters; reviewing monitoring reports to identify deficiencies, reviewing adequacy of issue escalation and issue resolution; and providing feedback to appropriate CRO contacts. Participate in co-monitoring activities. Communicate with CROs, vendors, and/or study sites as necessary to support the study, which includes monitoring email accounts related to studies. Conduct regulatory review of ICF changes and coordinate review by Executive Officer and contracts team. Coordinate study related meetings; take detailed minutes at meetings on decisions and action items and distribute to the team, as assigned. Other related duties as assigned to meet departmental and company objectives. QUALIFICATIONS AND EDUCATION REQUIREMENTSA minimum of a BA/BS degree is required. Degree in a health or science major preferred.2–4 years relevant experience in biotech, pharma, and/or CRO, including 1 year of clinical research industry experience. Working knowledge of clinical monitoring responsibilities and procedures. Previous experience with e TMF, CTMS, and IRT clinical trial systems is strongly preferred. Proficient in Microsoft Office Suite, especially Word and Excel. PREFERRED SKILLSStrong organizational skills and ability to prioritize workload to meet tight deadlines in a fast-paced and dynamic work environment. Strong interpersonal, written, and verbal communication skills. Flexible and adaptable to a small business workplace environment.
