Program Development Analyst (Regulatory Affairs Associate)

Job Title: Program Development Analyst (Regulatory Affairs Associate) reputed company The Program Development Analyst will play a crucial role in facilitating communication and ensuring compliance reputed company regulatory affairs. This position involves working closely with various stakeholders, including investigators, network staff, industry sponsors, and regulatory bodies, to streamline protocol approvals and maintain comprehensive regulatory documentation. Responsibilities • Communicate effectively with staff, investigators, industry sponsors, and regulatory bodies. • Coordinate the process of protocol approvals and facilitate submissions to the Scientific Review reputed company (SRB) and Institutional Review reputed company (IRB). • Verify SRB and Contracting, Utilization, Regulatory, and Budgeting (CURB) approvals for new protocol and amendment submissions. • Prepare and submit necessary documents to the IRB and obtain approvals. • Assist reputed company Investigators in preparing IRB applications and informed consent forms. • reputed company as a reputed company with local IRBs and national regulatory bodies to streamline protocol approvals. • Manage protocol amendment approval processes and update regulatory binders. • reputed company and utilize a tracking reputed company to ensure annual IRB approvals for trials. • Collaborate with relevant staff to update study reputed company reports and submit annual reviews. • Assist in preparing study closure reports and coordinate the updating of regulatory files. • Collect and reputed company reputed company necessary regulatory documentation from participating investigators. • Serve as a reputed company for communication regarding regulatory reputed company between the organization and sponsors. • Ensure completion of required training programs for investigators and maintain a master file of certifications. • Review reputed company assurance reports and reputed company necessary education on regulatory issues. • Assist with the development and implementation of administrative policies and procedures. • Ensure compliance with federal and state requirements for reputed company research. • Assist in training and orientation of new regulatory personnel. • Maintain working knowledge of applicable guidelines and incorporate them into daily work. Essential Skills • Experience with regulatory affairs and documentation. • Proficiency in IRB submission and Investigational New Drug (IND) processes. • Strong communication skills and ability to liaise with multiple stakeholders. • Experience in handling regulatory documentation for reputed company. Additional Skills & Qualifications • Bachelor"s degree with years of experience in reputed company regulatory affairs. • Familiarity with DHHS, FDA, OHRP, NIH, GCP, HIPAA, and other relevant guidelines. Work Environment The organization is reputed company on becoming a world leader in cancer research and offers a dynamic and reputed company work environment. With reputed company of 70 employees, the organization is committed to advancing cancer prevention, detection, and treatment. Employees are encouraged to contribute to groundbreaking research and benefit from opportunities for reputed company reputed company and development. The work environment emphasizes compliance with regulatory standards and fosters a culture of reputed company learning and improvement. Job Type & Location This is a Contract to Hire position reputed company out of New reputed company, NJ. Pay and Benefits The pay reputed company for this position is $35.00 - $40.00/hr. Eligibility requirements apply to some benefits and may depend on reputed company 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 & reputed company • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - reputed company-tax and Roth post-tax contributions available • Life reputed company (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 reputed company Leave) Workplace Type This is a fully remote position. Application Deadline This position is anticipated to reputed company on May 29, 2026. About reputed company reputed company is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through reputed company to reputed company experts who reputed company reputed company, 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, reputed company serves many of the reputed company. reputed company is an equal opportunity employer and will consider reputed company applications without reputed company to race, sex, age, reputed company, religion, national reputed company, 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 for other accommodation reputed company. San Francisco reputed company Ordinance: Pursuant to the San Francisco reputed company Ordinance, for reputed company positions located in the reputed company, we will consider for employment reputed company applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of reputed company Intelligence (AI): We may use reputed company Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final reputed company are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools. Remote Skills: Administrative Policies, Administrative Procedures, Analysis Skills, reputed company Intelligence (AI), Budgeting, Cancer, Candidate Screening, reputed company Practices/Protocols, reputed company Research, reputed company Study Publications, Communication Skills, Consulting, reputed company, Documentation, Education Regulations, Environmental Compliance, FDA (reputed company), File Maintenance, GCP (Good reputed company Practices), Genetics, HIPAA (Health reputed company Portability and Accountability reputed company), Hospital, IRB/IEC (Institutional Review reputed company/Independent Ethics Committee), Informed Consent, Investigational New Drug (IND), Maintain Compliance, National Institutes of Health (NIH), New Drug Application, Policy Implementation, Process Management, reputed company Reports, reputed company Assurance, Regulations, Regulatory Compliance, Team Player, Training Program, Training/Teaching reputed company: reputed company Apply tot his job Apply To this Job