Clinical Research Coordinator

Actalent; New Brunswick (NJ); On-site; USD 48,000 - 52,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) plan

Onsite work environment

Job summary

Actalent is seeking a Clinical Trial Specialist to support end-to-end oncology trial activities from protocol activation through patient enrollment and data capture. The role collaborates with research nurses, physicians, and sponsors to ensure compliant conduct under GCP guidelines.

The candidate will manage study tools, consent documentation, adverse event reporting, and sponsor communications while maintaining rigorous trial records across centers in New Jersey.

Qualifications

• Bachelor's degree required.
• 1–3 years of clinical research experience, preferably as a Clinical Research Coordinator.
• Experience in oncology clinical research and familiarity with tumour study groups.
• Informed consent processes and IRB/ethics documentation experience.

Responsibilities

• Coordinate initiation and activation of new clinical trial protocols with required regulatory approvals.
• Prepare and organize study tools and materials for efficient trial conduct.
• Use trials management software and MS Office to maintain study tools and data.
• Review patient charts and histories to confirm protocol eligibility and collect source documents.
• Ensure IRB-approved informed consent forms are properly obtained and filed.

Skills

Oncology clinical research

Informed consent

Recruitment & enrollment

Data tracking & reporting

Communication with patients

GCP & regulatory compliance

Attention to detail

Organizational skills

Education

Bachelors degree

Tools

Excel

Word

Access

Job description

Job Title: Clinical Trial Specialist

Job Description

The Clinical Trial Specialist coordinates and supports the full lifecycle of oncology clinical trials, from protocol initiation and activation through patient enrollment, data collection, safety reporting, and ongoing sponsor communication. This role ensures that all studies adhere to regulatory requirements, institutional policies, and Good Clinical Practice (GCP) guidelines while providing high‑quality support to research nurses, physicians, and patients.

Responsibilities

• Coordinate the initiation and activation of new clinical trial protocols, ensuring completion and verification of Scientific Review Board (SRB), Institutional Review Board (IRB), Human Research Oversight Committee (HROC), data collection plans, and finance/contract approvals prior to study activation.
• Prepare and organize study tools, including study binders, medication diaries, eligibility checklists, calendars, and flow sheets, to support accurate and efficient trial conduct.
• Use clinical trials management systems and software such as Excel and Word to develop and maintain study tools, tracking documents, and patient‑related materials.
• Collaborate with Research Nurse Clinicians and physicians to review patients charts and medical histories, confirm protocol eligibility, and obtain necessary source documents and medical record documentation.
• Ensure that IRB‑approved informed consent forms are properly obtained, signed, documented in the medical record, and that copies are provided to patients in accordance with regulatory and institutional requirements.
• Register consented research patients with study sponsors, including industry partners and National Cancer Institute (NCI) cooperative groups, and enter patient and study data into the clinical trials database.
• Maintain complete and accurate research records for all patients enrolled on clinical trials, including patient consent forms, eligibility documentation, case report forms (CRFs), registration confirmations, and corresponding source documents, across centers, community physicians offices, and hospitals.
• Assist, in collaboration with the Research Nurse Clinician and physician, in grading adverse events using the most recent NCI common toxicity criteria or protocol‑specific grading scales.
• Complete Serious/Unexpected Adverse Event (SAE) forms for internal and multicentre serious or unexpected adverse events as required by study sponsors, federal regulations, and institutional guidelines.
• Provide regular reports to tumour study group members and Principal Investigators on assigned studies using the clinical trials database and other reporting tools.
• Serve as a liaison with study sponsors, understanding and anticipating sponsor needs, scheduling monitoring visits and conference calls, and providing accurate, timely, and well‑supported responses to sponsor queries.
• Work with Research Nurse Clinicians to ensure that investigators and other personnel conduct studies according to the treatment plan, protocol requirements, and GCP guidelines.
• Support screening and recruitment of patients for clinical trials, helping to coordinate study visits and ensure smooth patient flow through the research process.
• Communicate comfortably and professionally with patients, answering questions related to study procedures and coordinating their participation in clinical trials.

Essential Skills

• Bachelors degree required.
• One to three years of relevant clinical research experience, preferably as a Clinical Research Coordinator or in a similar role.
• Experience in oncology clinical research, including familiarity with tumour study groups and oncology‑specific protocols.
• Demonstrated experience with informed consent processes, including obtaining, documenting, and maintaining consent forms in accordance with IRB requirements.
• Ability to recruit, screen, and enroll patients into clinical trials while maintaining protocol eligibility standards and accurate source documentation.
• Solid knowledge of computer software programs such as Excel, Word, and Access for data tracking, reporting, and development of study tools.
• Comfort and experience communicating directly with patients in a clinical research or healthcare setting.
• Strong attention to detail and ability to maintain accurate, complete research records and case report forms.
• Excellent organisational skills with the ability to manage multiple studies, deadlines, and competing priorities.
• Strong written and verbal communication skills and the ability to interact effectively with physicians, nurses, sponsors, and other research staff.
• Ability to follow GCP guidelines and institutional policies in the conduct of clinical trials.

Additional Skills & Qualifications

• Experience working with oncology disease‑specific groups such as breast, lung, gastrointestinal, phase I, or other tumour‑focused teams.
• Familiarity with NCI common toxicity criteria and protocol‑specific grading scales for adverse event assessment.
• Experience completing Serious/Unexpected Adverse Event (SAE) documentation for industry‑sponsored and cooperative group trials.
• Ability to provide clear, timely, and well‑organised responses to study sponsors and regulatory monitors.
• Demonstrated ability to be detail‑oriented, self‑accountable, and committed to high standards of professional excellence.
• Resourceful mindset with the ability to maximise available resources and proactively solve problems.
• Strong interpersonal skills and the ability to build collaborative relationships with multidisciplinary teams, including clinical operations, regulatory affairs, quality assurance, informatics, education, and finance.
• Commitment to ongoing personal and professional responsibility and continuous improvement in clinical research practices.

Work Environment

The role operates within a large, dynamic clinical operations structure that includes disease‑specific groups such as breast, lung, phase I, and gastrointestinal, as well as dedicated teams in regulatory affairs, quality assurance, informatics, education, and finance. The organisation supports approximately 100 full‑time research staff and manages around 300 active trials across all phases for both adult and paediatric populations, with roughly 5,000 subjects enrolled per year and a long‑term goal of significantly expanding active subject enrollment. Work spans a main site in Newark and multiple affiliated locaties across the state, supporting community physicians offices and hospitals. The environment is fast‑paced and highly collaborative, with substantial enrolment needs and exposure to a wide range of oncology studies, offering opportunities to work with complex protocols, sophisticated clinical trial management systems, and multidisciplinary teams dedicated to advancing cancer research.

Job Type & Location

This is a Contract to Hire position based out of New Brunswick, NJ.

Pay And Benefits

The pay range for this position is $35.00 - $38.00/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 programme 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 Programme Time Off/Leave (PTO, Vacation or Sick Leave)

Job Type & Location

This is a Contract to Hire position based out of New Brunswick, NJ.

Application Deadline

This position is anticipated to close on Nov 16, 2026.

Workplace Type

This is a fully onsite position in New Brunswick, NJ.

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 specialised 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, colour, 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.