Research Data Associate

ACTalent; New York (NY); On-site; USD 32,000 - 45,000; Full time

Job summary

Actalent is seeking a Research Data Associate to support regulatory and data activities for pediatric hematology and oncology trials. You will manage submissions, documentation, and ongoing regulatory requirements under supervision, ensuring compliance across a large portfolio of studies.

This is a 12-month contract-to-hire, onsite in New York, with a 35-hour work week. The role emphasizes data accuracy, regulatory documentation, and coordination with IRB and study teams to keep studies

Qualifications

• Experience with clinical data handling and data entry.
• Familiarity with regulatory documents and regulatory affairs.
• Ability to manage study paperwork including IRB submissions.
• Strong organizational skills to track multiple studies and deadlines.
• Attention to detail maintaining regulatory binders.
• Effective written and verbal communication with IRB and study teams.

Responsibilities

• Activate and initiate new clinical trials per regulatory requirements.
• Process protocol amendments and personnel changes with proper documentation.
• Coordinate and submit continuing review applications.
• Maintain regulatory compliance across active studies.
• Prepare materials for monitoring visits and audits.
• Maintain study documents and regulatory binders.

Skills

Data handling

Regulatory docs

IRB submissions

Documentation accuracy

Organizational skills

Communication

Computer systems

Fast-paced work

Education

Bachelor's degree

Job description

Job Description

This role offers an exciting opportunity to contribute to clinical research by providing direct data and regulatory support for clinical trials, studies, and general research activities under direct supervision. The Research Data Associate helps ensure that clinical trials remain compliant and progress smoothly through the regulatory process by managing submissions, documentation, and ongoing regulatory requirements for a large portfolio of studies in pediatric hematology and oncology.

Job Title: Research Data Associate

Duration: 12-month contract to hire

Job Description

This role offers an exciting opportunity to contribute to clinical research by providing direct data and regulatory support for clinical trials, studies, and general research activities under direct supervision. The Research Data Associate helps ensure that clinical trials remain compliant and progress smoothly through the regulatory process by managing submissions, documentation, and ongoing regulatory requirements for a large portfolio of studies in pediatric hematology and oncology.

Responsibilities

• Activate and initiate new clinical trials in alignment with regulatory and institutional requirements.
• Process protocol amendments and personnel changes, ensuring all updates are accurately documented and submitted.
• Coordinate and submit continuing review applications to maintain active study approval.
• Maintain regulatory compliance across active studies by tracking and fulfilling all regulatory obligations.
• Prepare documentation and materials for study monitoring visits, sponsor visits, and regulatory audits.
• Maintain, organize, and update regulatory binders and essential study documents for each trial.
• Track study renewals and regulatory deadlines to ensure timely submissions and prevent lapses in approvals.
• Communicate directly with the Institutional Review Board (IRB) regarding submissions, amendments, and ongoing study requirements.
• Ensure investigator and study staff documentation remains current, including medical licenses, training certifications, CVs, and other supporting regulatory documents.
• Support regulatory oversight for approximately 100 active clinical trials at various stages of conduct.
• Manage renewals and regulatory submissions for approximately 510 studies per month.
• Work with studies spanning multiple phases and disease areas within pediatric hematology and oncology.
• Maintain a high level of organization to manage heavy documentation, compliance tracking, and strict deadlines.
• Perform primarily computer-based work focused on ongoing regulatory documentation responsibilities.
• Operate effectively in a fast-paced environment with a consistent workflow and time-sensitive tasks.

Essential Skills

• Experience or strong interest in clinical data handling, data entry, and documentation accuracy.
• Understanding or exposure to regulatory documents and regulatory affairs in a clinical research setting.
• Ability to manage study paperwork, including IRB submissions, protocol amendments, and continuing reviews.
• Strong organizational skills with the ability to track multiple studies, deadlines, and regulatory requirements simultaneously.
• High attention to detail when preparing and maintaining regulatory binders and essential study documents.
• Effective written and verbal communication skills for direct interaction with the Institutional Review Board and internal study teams.
• Comfort working extensively with computer-based systems and electronic documentation.
• Ability to work efficiently in a fast-paced, deadline-driven environment.

Additional Skills & Qualifications

• Bachelor's degree required.
• Recent graduates are encouraged to apply.
• Prior exposure to clinical research through internships, research assistant roles, regulatory internships, or academic research is a plus but not required.
• Educational background in life sciences, public health, psychology, biology, biomedical sciences, or a related field is preferred.
• Strong willingness to learn and grow within the field of clinical research.
• Interest in pediatric hematology and oncology research is beneficial.

Work Environment

This position is part of a pediatric hematology and oncology research group that supports clinical studies focused on cancer and blood disorders. The role is fully onsite, based at a research facility in New York, New York. The standard schedule is Monday through Friday, 9:00 a.m. to 5:00 p.m., with a one-hour lunch break, resulting in a 35-hour work week. You will work closely with a collaborative team of coordinators and regulatory staff who are onsite and engaged in supporting a large portfolio of active clinical trials. Most work is computer-based and involves handling regulatory documentation, tracking compliance, and meeting frequent deadlines in a fast-paced environment. This is a 12-month contract-to-hire opportunity, offering the potential to transition into a longer-term role based on performance and organizational needs.

Job Type & Location

This is a Contract position based out of New York, NY.

Pay And Benefits

The pay range for this position is $28.00 - $28.00/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 & Location

This is a Contract position based out of New York, NY.

Application Deadline

This position is anticipated to close on Nov 23, 2026.

Workplace Type

This is a fully onsite position in New York,NY.

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 [e-mail] 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.