Sr. Clinical Research Coordinator - Early Phase

Actalent; Deutschland; Hybrid; EUR 42.000 - 50.000; Vollzeit

Benefits dieser Stelle

Comprehensive benefits package

Generous PTO and holidays

Tuition and professional development

Zusammenfassung

Actalent is seeking an experienced Sr Clinical Research Coordinator (Sr CRC) in Oncology to lead trial execution within a diverse portfolio of investigator-initiated and industry-sponsored studies. This role supports investigators, sponsors, and teams while upholding GCP and regulatory standards.

The ideal candidate will independently manage multiple studies, mentor junior staff, and thrive in a fast-paced academic environment.

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 startup, enrollment, maintenance, and closeout of trials.
• Screen, recruit, consent, and enroll participants.
• Conduct study visits and ensure protocol adherence.
• Maintain 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 data queries within EDC systems.
• Coordinate specimen collection, processing, and shipment as required.
• Assist with training and mentorship of junior research staff.
• Ensure compliance with GCP, ICH guidelines, HIPAA, and applicable regulations.

Kenntnisse

Clinical research coordination

GCP

FDA regulations

IRB processes

Project management

Communication

Multitasking

Ausbildung

Bachelor's degree in science/healthcare or related field

CCRC/CCRP certification (preferred)

Tools

EDC systems (Medidata Rave/REDCap)

Jobbeschreibung

We are seeking an experienced Sr Clinical Research Coordinator (Sr. CRC) - ONCOLOGY to join a growing clinical research team supporting a diverse portfolio of investigator-initiated and industry-sponsored clinical trials. This is an opportunity to play a key leadership role in study execution while working alongside renowned physicians, research professionals, and multidisciplinary healthcare teams. If you are passionate about clinical research, patient care, and driving innovative therapies forward, we'd love to connect with you.

Position Summary

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

Why Join Us?

• Opportunity to work on cutting-edge clinical research programs
• Collaborate with leading physicians and researchers
• Exposure to a wide variety of therapeutic areas and study phases
• Career growth and advancement opportunities
• Comprehensive benefits package
• Generous paid time off and holidays
• Tuition and professional development opportunities
• Make a meaningful impact on patient outcomes and the future of medicine

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 jobclassification and length of employment. Benefits are subject to change and may besubject to specific elections, plan, or program terms. If eligible, the benefitsavailable 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 Sep 18, 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 withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment 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 thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector:It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall 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 applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.