Job Title: Clinical Research AuditorJob Description We are seeking a highly experienced Clinical Research Auditor to join our team. The ideal candidate will have extensive experience in clinical research, particularly in monitoring, auditing, research nursing, or related fields. This role requires a strong understanding of human subjects clinical research and the principles of conducting compliance oversight. Responsibilities + Conduct audits of clinical trials to ensure compliance with federal regulations, GCP, and IND/IDE requirements. + Monitor and review clinical research activities to ensure adherence to protocols and regulatory standards. + Collaborate with research teams to address compliance issues and implement corrective actions. + Maintain detailed documentation of audit findings and follow-up actions. + Provide training and guidance to research staff on compliance and regulatory matters. + Prepare reports and presentations for regulatory agencies and internal stakeholders. + Ensure the protection of human subjects and the integrity of research data. Essential Skills + Minimum of 7 years of clinical research experience as a monitor/auditor, research nurse, research coordinator, regulatory affairs, quality control and assurance, or compliance. + Strong knowledge of human subjects clinical research. + Excellent understanding of federal regulations, GCP, and IND/IDE in both adult and pediatric research. + Proficiency in MS Word and Excel. + Strong organizational and time management skills. + Attention to detail and ability to handle highly confidential and sensitive data. + Ability to multi-task, prioritize, and adapt in a fast-paced environment. + Strong judgment, resourcefulness, and initiative. Additional Skills & Qualifications + Nursing degree (RN/BSM) or BSN/MSN. + Familiarity with medical records/patient charts organization and terminology. Work Environment The role requires working in the office twice a week, with flexibility for additional days as needed based on audit schedules or meetings. The work environment is supportive, collaborative, and intellectually stimulating. Employees enjoy generous vacation time, paid holidays, a paid winter break, and numerous benefits including 403b contributions, life insurance, tuition assistance, discounts on cellphones, mortgage interest, transit passes, tickets to events, and assistance with child care. Pay and Benefits The pay range for this position is $38.00 - $42.00 Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Philadelphia,PA. Application Deadline This position will be accepting applications until Jan 28, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.