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Clinical Project Associate Jobs in Haskell, NJ (NOW HIRING)

NYULMC

Project Manager

New York, NY · On-site

... clinical trials and patient enrollments. The PM, working with the associate director and GCT ... The role requires expertise in project and staff management and regulatory affairs. Job ...

Zealthy

Clinical Operations Associate

New York, NY · On-site

We are seeking a Clinical Operations Associate to support Zealthy's fast-growing clinical team ... Lead ad-hoc projects from planning through execution * Serve as a critical support resource during ...

NS Pharma Inc

Director, Clinical Research

Paramus, NJ · On-site

$210K - $240K/yr

Manage and resolve project performance issues (issue management) if they arise. * Lead, oversee ... Supervise two (2) or three (3) Senior Clinical Study Managers and one Associate Director; including ...

Montefiore

PROJECT MANAGER II (JR229788)

Yonkers, NY · On-site

... associates, please click here . OverviewThe Senior Project Manager leads projects related to the ... The main portfolio of the CHIS group is in clinical growth initiatives that center around improving ...

Essen Medical Associates

Project Coordinator

Bronx, NY · On-site

This role will be based in The Bronx and will work closely with clinical leaders, administrative ... Project & Program Coordination * Coordinate timelines, resources, and deliverables for outpatient ...

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Clinical Project Associate information

See Haskell, NJ salary details

$12

$32

$56

How much do clinical project associate jobs pay per hour?

As of Aug 10, 2026, the average hourly pay for clinical project associate in Haskell, NJ is $32.00, according to ZipRecruiter salary data. Most workers in this role earn between $21.44 and $42.21 per hour, depending on experience, location, and employer.

What is a clinical project associate?

A Clinical Project Associate (CPA) is a professional who supports the planning, execution, and management of clinical trials in the pharmaceutical, biotechnology, or medical device industries. Their responsibilities often include coordinating study documentation, assisting with regulatory submissions, tracking project timelines, and facilitating communication among study teams. CPAs play a crucial role in ensuring that clinical trials are conducted efficiently, ethically, and in compliance with regulatory standards. They work closely with clinical project managers, research associates, and other team members to help bring new therapies and treatments to market.

What are the typical responsibilities of a clinical project associate?

As a Clinical Project Associate, you will play a vital role in ensuring the smooth execution of clinical trials by handling administrative and logistical tasks. Your responsibilities often include maintaining study documentation, coordinating meetings, tracking project timelines, and supporting communication between internal teams and external partners such as clinical sites and vendors. You may also assist with regulatory submissions and help monitor compliance with study protocols. This position offers excellent exposure to the clinical research process and can be a stepping stone to more advanced roles within clinical operations.

What are the key skills and qualifications needed to thrive as a clinical project associate?

To thrive as a Clinical Project Associate, you need a background in life sciences or a related field, attention to detail, and strong organizational skills. Familiarity with clinical trial management systems (CTMS), regulatory documentation, and tools like Microsoft Office is typically required. Excellent communication, teamwork, and time management abilities help professionals excel in supporting project coordination. These skills are crucial for ensuring regulatory compliance, smooth project execution, and effective collaboration within clinical research teams.

What is the difference between Clinical Project Associate vs Clinical Research Coordinator?

AspectClinical Project AssociateClinical Research Coordinator
CredentialsBachelor's degree often required; certifications like CCRP beneficialBachelor's degree in health or related field; certifications like CCRP common
Work EnvironmentTypically works with project teams, sponsors, and CROs in clinical trial settingsWorks directly with patients, investigators, and site staff at clinical trial sites
Employer & IndustryPharmaceutical companies, CROs, biotech firmsHospitals, clinics, research sites
Search & Comparison IntentHigh overlap in responsibilities and certificationsSimilar roles but more patient-facing

The Clinical Project Associate primarily supports clinical trial management from a project perspective, working with sponsors and CROs. In contrast, the Clinical Research Coordinator focuses on patient interactions and site management. Both roles require similar educational backgrounds and certifications, but their work environments and daily tasks differ significantly.

What cities near Haskell, NJ are hiring for Clinical Project Associate jobs? Cities near Haskell, NJ with the most Clinical Project Associate job openings:
Clinical Project Associate jobs near you
Infographic showing various Clinical Project Associate job openings in Haskell, NJ as of June 2026, with employment types broken down into 2% As Needed, 80% Full Time, 11% Part Time, 1% Temporary, and 6% Contract. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution, with an average salary of $66,561 per year, or $32 per hour.

Associate Director, CMC Regulatory Affairs

NS Pharma Inc

Paramus, NJ • On-site

$170K - $190K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 12 days ago

Job description

NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We’re exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. In Japan

Summary:

CMC Regulatory Affairs develops and executes CMC regulatory strategies for investigational and marketed products in close collaboration with regulatory leadership, with a primary focus on U.S. Health Authority (FDA) interactions.

This role coordinates and oversees the preparation and review of CMC-related regulatory documents, supports Health Authority meetings and follow-up commitments, and partners closely with cross-functional teams in the U.S. (NS Pharma) and Japan (Nippon Shinyaku HQ) to ensure global alignment and timely issue resolution.

This is a hybrid role that requires two days in the Paramus, NJ office.

Responsibilities:

  • Plan and execute CMC regulatory activities including IND M3/IMPD-Quality for investigational products, and NDAs/BLAs and post-approval supplements/variations for marketed products.
  • Lead and coordinate CMC-related FDA meetings (e.g., pre-IND; Type A, B, and C; and NDA/BLA-related meetings) in collaboration with Regulatory Affairs Strategy, including meeting strategy, material preparation, internal alignment, and submission logistics.
  • Coordinate and oversee CMC dossier readiness and the preparation/review of CMC regulatory deliverables in eCTD format, including scientific/technical input for full regulatory compliance.
  • Serve as the day-to-day CMC regulatory liaison for timely submission-ready of CMC-document through IND/CTA/NDA/BLA.
  • Coordinate and support responses to CMC-related Health Authority information requests/questions in alignment with cross-functional stakeholders.
  • Manage external CMC regulatory expert consultations (consultants/contractors) including selection support, deliverable expectations, quality review, and timeline/budget oversight.
  • Partner with cross-functional teams (CMC, QA, Clinical, Nonclinical, Project Management, etc.) to align regulatory strategy and execution.
  • Establish regulatory classification and filing strategy for CMC changes in manufacturing, analytical testing, and supply chain throughout the product life cycle.
  • Ensure consistency and traceability of CMC regulatory positions across key documents (e.g., Module 2 QoS and Module 3 content).
  • Maintain CMC regulatory documentation controls and inspection/audit readiness (e.g., version control, document traceability, decision logs, and submission trackers) to support timely, high-quality deliverables.
  • Monitor and communicate evolving global regulatory requirements and guidance (e.g., ICH, FDA, EU), and proactively assess impacts and risks, and take required actions for programs.
  • Support operational regulatory activities as needed, including coordination of cross-functional meetings, maintenance of submission trackers, and documentation of decisions and action items.

Experience (Required):

  • Strong knowledge of U.S. FDA CMC regulatory requirements.
  • Strong knowledge of ICH Quality guidelines
  • Excellent English communication skills (written and verbal) suitable for Health Authority interactions and regulatory documentation.
  • Working knowledge of CMC CTD/eCTD structure and the ability to ensure CMC content readiness and consistency.
  • Experience working effectively in a cross-functional team environment.

Preferred Qualifications:

  • Strong knowledge of GMP
  • Experience in rare disease
  • Working understanding of EU regulatory requirements (EMA) and ability to support EU-related activities.
  • Demonstrated ability to develop and execute CMC regulatory strategy throughout the product lifecycle.
  • Excellent technical writing and editing skills for regulatory documentation and Health Authority correspondence (clear, consistent, defensible rationale).
  • Strong organizational and project management skills, including prioritization, issue/risk tracking, attention to detail, and document control discipline (version control, traceability, decision documentation).

Education:

  • A bachelor’s degree in pharmacy, chemistry, or a related scientific discipline, or equivalent experience is required. MSc or PhD preferred.
  • Typically, 8 – 10 years of experience in the CMC field of the pharmaceutical/biotechnology industry, including a minimum of 5 years of CMC regulatory affairs.
  • A minimum of one NDA/BLA and multiple IND/CTA is also preferred.

Compensation And Benefits:

NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job.

The annualized target salary range for this role is $170,000 to $190,000; actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit.

Other benefits include:

  • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs
  • Discretionary Bonus Programs and Long-term Incentive Plan
  • Retirement Savings 401k with company match
  • Generous Paid Time Off, Sick Time & Paid Holidays
  • Career Development, Progression and Training
  • Flexible Work Arrangement Programs
  • Paid Parental Leave
  • Year-End Paid Holiday Shutdown

Applications will be accepted until August 31, 2026, or until a candidate is hired. Applicants not hired will remain in our Talent community for future opportunity consideration. Thank you for your interest in NS Pharma.

NS Pharma is an EEO employer.