Sr. Clinical Research Coordinator

Actalent; United States; Hybrid; USD 48.000 - 58.000; Vollzeit

Benefits dieser Stelle

Medical, dental & vision

401(k) plan

Life Insurance

Short/long-term disability

HSA

PTO / Vacation

Zusammenfassung

Actalent is seeking a Sr Clinical Research Coordinator to lead day-to-day management of clinical trials from startup to closeout in a hybrid Bronx, NY setting. You will coordinate startup, enrollment, visits, data integrity, regulatory submissions, and audits, while mentoring junior staff.

The ideal candidate will have 3+ years of independent trial coordination, strong GCP/FDA/IRB knowledge, and excellent organizational and communication skills to manage competing priorities in a fast-paced

Qualifikationen

• Bachelor's degree in a scientific, healthcare, or related field.
• 3+ years of clinical research coordination experience.
• Experience managing clinical trials independently.
• Strong understanding of GCP, FDA regulations, and IRB processes.
• Experience with patient recruitment, consenting, and study management.
• Excellent organizational, communication, and project management skills.
• Ability to manage multiple priorities in a deadline-driven environment.

Aufgaben

• Coordinate all aspects of clinical trial operations, including startup, enrollment, maintenance, and closeout.
• Screen, recruit, consent, and enroll study participants.
• Conduct study visits and ensure protocol adherence.
• Maintain accurate source documentation and electronic regulatory binders.
• Manage IRB submissions, amendments, continuing reviews, and study correspondence.
• Prepare for sponsor, FDA, and internal audits/inspections.
• Serve as the primary point of contact for sponsors, CROs, and investigators.
• Track subject enrollment, study milestones, and timelines.
• Monitor study budgets and research-related expenses.
• Review and resolve data queries within electronic data capture (EDC) systems.
• Coordinate specimen collection, processing, and shipment when required.
• Assist with training and mentorship of junior research staff.
• Ensure compliance with GCP, ICH guidelines, HIPAA, and applicable regulations.

Kenntnisse

GCP knowledge

FDA regulations

IRB processes

Clinical trial coordination

Participant recruitment

Ausbildung

Bachelor's degree in science/healthcare

Tools

Medidata Rave

REDCap

Jobbeschreibung

The Sr Clinical Research Coordinator is responsible for the day-to-day management and coordination of clinical trials from study startup through closeout. This individual will serve as a key resource for investigators, sponsors, and study teams while ensuring compliance with protocol requirements, Good Clinical Practice (GCP), federal regulations, and institutional policies.

The ideal candidate is a proactive research professional who can independently manage multiple studies, mentor junior team members, and thrive in a fast-paced academic environment.

Key Responsibilities

• Coordinate all aspects of clinical trial operations, including startup, enrollment, maintenance, and closeout activities
• Screen, recruit, consent, and enroll study participants
• Conduct study visits and ensure protocol adherence
• Maintain accurate source documentation and electronic regulatory binders
• Manage IRB submissions, amendments, continuing reviews, and study correspondence
• Prepare for sponsor, FDA, and internal audits/inspections
• Serve as the primary point of contact for sponsors, CROs, and investigators
• Track subject enrollment, study milestones, and timelines
• Monitor study budgets and research-related expenses
• Review and resolve data queries within electronic data capture (EDC) systems
• Coordinate specimen collection, processing, and shipment when required
• Assist with training and mentorship of junior research staff
• Ensure compliance with GCP, ICH guidelines, HIPAA, and applicable regulations

Qualifications

Required

• Bachelor's degree in a scientific, healthcare, or related field
• Minimum 3+ years of clinical research coordination experience
• Experience managing clinical trials independently
• Strong understanding of GCP, FDA regulations, and IRB processes
• Experience with patient recruitment, consenting, and study management
• Excellent organizational, communication, and project management skills
• Ability to manage multiple priorities in a deadline-driven environment

Preferred

• Experience working within an academic medical center, hospital system, or research institution
• Oncology, cardiology, neurology, rare disease, or other complex therapeutic area experience
• CCRC, CCRP, or equivalent professional certification
• Experience supporting multi-site or industry-sponsored clinical trials
• Knowledge of EDC systems such as Medidata Rave, REDCap, or similar platforms

Job Type & Location

This is a Contract to Hire position based out of bronx, NY.

Pay and Benefits

The pay range for this position is $35.00 - $42.00/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)

Workplace Type

This is a hybrid position in bronx,NY.

Application Deadline

This position is anticipated to close on Oct 22, 2026.

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.