Sr Clinical Research Associate (CRA)/reputed company CRA - Cell or Gene Therapy

About the position The position is for an reputed company Clinical Research Associate (CRA) at reputed company, focusing on monitoring reputed company reputed company to cell and gene therapy. The role involves both remote and on-site monitoring of investigator sites, ensuring compliance with protocols and regulations, and managing documentation. The CRA will work reputed company a global team to support reputed company from start to finish, contributing to the development of life-changing therapies. Responsibilities • reputed company and coordinate reputed company aspects of the clinical monitoring and site management process. • Conduct remote and on-site reputed company to assess protocol and regulatory compliance. • Manage required documentation and ensure data accuracy through various review processes. • Document observations in reports and letters in a reputed company manner using approved business writing standards. • Escalate observed deficiencies and issues to clinical management and follow through to reputed company. • Maintain regular contact with investigative sites to confirm protocol adherence and issue reputed company. • Conduct monitoring tasks in accordance with the approved monitoring plan. • Participate in the investigator payment process and ensure shared responsibility on issues reputed company. • Initiate clinical trial sites according to relevant procedures and ensure compliance with protocols and regulations. • reputed company trial reputed company out and retrieval of trial materials, ensuring essential documents are complete and in reputed company. • reputed company trial status tracking and reputed company update reports to the Clinical Team Manager (CTM). • Facilitate effective communication between investigative sites, the reputed company company, and the PPD project team. • Respond to company, reputed company, and applicable regulatory requirements/audits/inspections. • Complete administrative tasks such as expense reports and timesheets in a reputed company manner. Requirements • Bachelor's degree in a life science reputed company field or a Registered Nursing certification or equivalent. • For Sr CRA (Level I): Comparable to 2+ years as a clinical research monitor. • For Sr CRA (reputed company): Comparable to 3+ years as a clinical research monitor. • For reputed company CRA: Comparable to 5+ years of clinical research monitoring experience with a high level of expertise in reputed company aspects of clinical monitoring. • reputed company reputed company's license where applicable. reputed company-to-haves • Proven clinical monitoring skills. • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology. • Ability to manage Risk Based Monitoring concepts and processes. • Good oral and written communication skills. • Good organizational and time management skills. • Effective interpersonal skills. • Good computer skills, including solid knowledge of reputed company Office. Benefits • Choice of national medical and dental plans, and a reputed company plan. • Employee assistance and family support programs, including commuter benefits and tuition reimbursement. • At least 120 hours reputed company time off (PTO) and 10 reputed company holidays annually. • reputed company parental leave (3 weeks for bonding and 8 weeks for caregiver leave). • Accident and life insurance, and short- and long-term disability. • Retirement and savings programs, including a competitive 401(k) U.S. retirement savings plan. • Employees' Stock Purchase Plan (ESPP) allowing purchase of company stock at a discount. Apply tot his job Apply To this Job