Clinical Research Coordinator

ACTalent; New Haven (CT); Hybrid; USD 44,000 - 48,000; Full time

Job summary

Actalent is seeking a Clinical Research Coordinator II in New Haven, CT for a 6-month contract to hire. The role covers supervisory, operational, and patient-facing responsibilities across moderately to highly complex protocols, with compliance to ICH/GCP and regulatory standards.

The CRC II will manage trial initiation, execution, maintenance, and completion, and collaborate with investigators and sponsors to ensure accurate data capture and timely reporting.

Qualifications

• Knowledge of GCP and FDA regulations.
• Experience coordinating clinical trials.
• Proficient with electronic medical records (EMR).
• Strong communication and documentation skills.
• Attention to detail and ability to manage multiple tasks.

Responsibilities

• Serve as the primary oversight specialist on clinical and operational processes for moderately to highly complex protocols.
• Manage, implement, and evaluate all aspects of clinical trial conduct including study initiation, execution/maintenance, completion, and administration.
• Contribute to study feasibility reviews and make protocol-based recommendations.
• Ensure adherence to protocols, maintain documentation, and meet regulatory requirements.
• Identify noncompliance and report deviations to appropriate parties.
• Advise the Principal Investigator on protocol issues and lab reports as required.
• Analyze, document, and convey study data with timely reporting.
• Oversee tracking and reporting of adverse events and protocol deviations.
• Assess trial execution and provide education or recommendations for improvement.
• Collaborate on corrective and preventive action plans and training.

Skills

GCP and FDA regulations

Clinical trial coordination

EMR systems

Communication skills

Attention to detail

Education

Bachelor's degree in health-related discipline

ACRP/SOCRA certification preferred

Tools

EMR software

Data management systems (e.g., Medidata)

Job description

Job Title: Clinical Research Coordinator II

Duration: 6-month contract to hire

Job Description

The Clinical Research Coordinator II (CRC II) plays a crucial role in providing research services to patients participating in clinical trials. This role involves overseeing, planning, tracking, and ensuring that clinical activities for study participants are conducted according to approved protocols. The CRC II collaborates within a multidisciplinary environment, maintaining professionalism and effective communication with both internal and external colleagues. This position includes direct patient contact and managing the clinical and operational aspects of moderately to highly complex study protocols.

Responsibilities

• Serve as the primary oversight specialist on clinical and operational processes for moderately to highly complex protocols.
• Manage, implement, and evaluate all aspects of clinical trial conduct including study initiation, execution/maintenance, completion, and administration.
• Contribute to study feasibility reviews and make recommendations based on protocol analysis and knowledge of clinical trials, operations, and ICH/GCP, federal regulation, and institutional processes.
• Ensure adherence to study protocols, maintain accurate documentation, and meet regulatory and protocol requirements and guidelines per ICH/GCP, federal regulation, and institutional and sponsor requirements.
• Identify instances of noncompliance and deviations from protocol and report them to the appropriate parties.
• Advise the Principal Investigator through updates on protocol issues, status of signatures, and clinical significance on lab reports, ECGs, adverse events, and other documents as required.
• Analyze, document, and convey study data. Collaborate with assigned staff to oversee and ensure that report forms are accurately documented and completed in a timely manner.
• Oversee the tracking and reporting of adverse events, serious adverse events, protocol waivers, deviations, and violations.
• Assess trial execution program-wide, identify areas needing improvement or correction, and provide education and/or recommendations.
• Collaborate with Investigators and Research Managers in the preparation and execution of corrective and preventative action plans and ensure implementation and adherence to stated plans.
• Collaborate with the Quality Education Unit to contribute to the design of CRC trainings and continuing education.
• Participate in interim monitoring visits, internal audits, and external audits/inspections.
• Oversee the work and advise on protocol management and recruitment to CRC I development.
• Monitor, interpret, and communicate federal and state regulations, and local policies for new guidance, updates, or policies.
• Perform other duties as assigned.

Essential Skills

• Strong professionalism, judgment, and ability to handle confidential information.
• Knowledge of clinical research terminology and regulatory requirements, including GCP, FDA regulations, and HIPAA.
• Self-directed with the ability to manage multiple studies independently.
• Advanced interpersonal and communication skills, both written and oral.
• Ability to manage multiple tasks in a fast-paced environment with strong attention to detail.
• Bachelor's degree in a health-related discipline, or other related field and two years of clinical research experience.
• Minimum of one year of experience in clinical trials coordination.
• Knowledge of Good Clinical Practices (GCP) and Federal Regulations is required.

Additional Skills & Qualifications

• Knowledge of clinical trial management systems and experience with electronic medical records (EMR).
• Oncology experience is preferred.
• Bachelor's degree in a scientific, health-related, or business administration field preferred; advanced research training is a plus.
• Demonstrated experience in clinical trials coordination.
• Certification from ACRP/SOCRA or equivalent is preferred.

Work Environment

The position requires working five days per week on-site with the ability to work one day remotely, depending on patient demand. The work environment offers the opportunity to support cutting‑edge research while ensuring compliance with complex billing and regulatory standards, directly impacting patient care and clinical trial integrity. This role involves partnering with cross-functional stakeholders across research, finance, and compliance, gaining exposure to high‑impact operations within a world‑renowned academic medical center. The environment provides a mission‑driven atmosphere, strong professional growth, and the chance to contribute to advancements in cancer research.

Job Type & Location

This is a Contract to Hire position based out of New Haven, CT.

Pay and Benefits

The pay range for this position is $32.00 - $35.00/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 to Hire position based out of New Haven, CT.

Application Deadline

This position is anticipated to close on Nov 25, 2026.

Workplace Type

This is a fully onsite position in New Haven,CT.

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.