Clinical Protocol Writer

Job Title: Clinical Protocol WriterJob DescriptionThe Manager of Clinical Quality Assurance and Auditing will oversee audits of sponsor processes, trial master files, investigator sites, vendors, and systems, while ensuring compliance with corporate policies and global regulations. This role requires minimal supervisory oversight.

Responsibilities

• Conduct Good Clinical Practices (GCP) Risk Assessments.
• Assist in the development and implementation of the annual QA-GCP audit plan using a risk-based approach.
• Develop audit agendas and communications, such as pre-audit document requests, with auditees for each assigned audit project.
• Conduct audits ensuring completion timelines are met and compliance with all applicable SOPs, policies, and global regulations.
• Escalate audit issues and concerns to QA management.
• Produce audit reports and corrective action tables.
• Develop status reports with key metrics on audit progress.
• Issue applicable audit certificates and manage corrective and preventive action tables.
• Maintain accurate and timely documentation of assigned QA activities.
• Prepare with line functions and QA management in developing corrective action plans.
• Analyze and report trends in audit findings as requested.
• Review and assess key metrics such as the quality of TMF structure, risks, and project timelines.
• Develop training materials and activities for auditees.
• Participate in program and protocol team meetings as the QA Representative.
• Maintain knowledge on industry-leading practices and current regulations surrounding GCP compliance.
• Participate in regulatory inspection activities for sponsors and sites.

Essential Skills

• Experience in clinical trials and GCP regulations.
• Experience in site audits, quality assurance audits, and vendor audits.
• Strong knowledge of global regulatory requirements for clinical trials and ICH/GCP guidelines.
• Ability to work independently to complete assigned tasks.
• Solid written and verbal communication, analytical, and problem-solving skills.
• Flexibility, high motivation, strong organizational skills, and multitasking ability.
• BA/BS degree within a scientific discipline.

Additional Skills & Qualifications

• Pre-Approval Inspection readiness audit experience.
• Experience in clinical operations and handling trial essential documents.
• GLP auditing experience is a plus.
• Knowledge of GXPs is a plus.
• Proficient in Microsoft Word, Excel, PowerPoint, and Project.

Work EnvironmentThe role involves a hybrid work environment, assisting with the completion of both internal and external audits. The position supports a fast-paced and dynamic environment, requiring management of shifting priorities to meet critical deadlines. Job Type & LocationThis is a Contract position based out of bronx, NY. Pay and BenefitsThe pay range for this position is $80.00 - $85.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.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) Job Type & LocationThis is a Contract position based out of bronx, NY. Application DeadlineThis position is anticipated to close on Nov 23, 2026. Workplace TypeThis is a fully remote position.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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified 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 continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.