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Clinical Study Assistant Jobs in Raleigh, NC (NOW HIRING)

CTI

Clinical Project Coordinator

Raleigh, NC · On-site

... * Assist other departments as needed throughout all phases of clinical projects (e.g., Regulatory Affairs Study Start-up, Data Management, Safety, etc.) * Provide support in developing new Clinical ...

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Clinical Study Assistant information

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How much do clinical study assistant jobs pay per hour?

As of Sep 2, 2026, the average hourly pay for clinical study assistant in Raleigh, NC is $19.66, according to ZipRecruiter salary data. Most workers in this role earn between $16.11 and $22.64 per hour, depending on experience, location, and employer.

What is a clinical study assistant?

Clinical Study Assistants are professionals who support the conduct of clinical trials by handling administrative tasks, maintaining study documentation, and ensuring regulatory compliance. They work closely with clinical research teams to coordinate schedules, communicate with study sites, and help manage trial materials. Their role is crucial in ensuring that clinical studies run smoothly, efficiently, and according to protocols and regulatory guidelines.

What are the key skills and qualifications needed to thrive as a clinical study assistant?

To thrive as a Clinical Study Assistant, you need strong organizational skills, attention to detail, and a background in life sciences or related fields, often supported by a bachelor's degree. Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC) platforms, and regulatory documentation processes is typically required. Effective communication, teamwork, and problem-solving skills help you navigate complex study protocols and collaborate with diverse stakeholders. These abilities are crucial for ensuring the accuracy, compliance, and smooth operation of clinical research studies.

What are the main challenges a clinical study assistant might face when supporting clinical trial operations?

A Clinical Study Assistant often encounters challenges such as managing multiple tasks under tight deadlines, ensuring accurate documentation, and coordinating communication between research teams, sponsors, and regulatory bodies. Additionally, adapting to evolving study protocols and maintaining compliance with strict regulatory requirements can be demanding. Strong organizational skills, attention to detail, and proactive communication are essential for navigating these challenges successfully.

What is the difference between Clinical Study Assistant vs Clinical Research Coordinator?

AspectClinical Study AssistantClinical Research Coordinator
CredentialsTypically requires a bachelor's degree in health sciences or related fieldUsually requires a bachelor's degree, often with additional certifications in clinical research
Work EnvironmentSupports clinical trials in hospitals, research centers, or pharmaceutical companiesManages entire clinical studies, coordinating between sites, staff, and sponsors
Employer & IndustryHospitals, research institutions, pharmaceutical companiesAcademic medical centers, hospitals, research organizations
Search & Comparison IntentOften compared for entry-level roles supporting clinical trialsCompared for roles with broader responsibilities in clinical study management

The Clinical Study Assistant primarily supports clinical trial activities by assisting with data collection and documentation, while the Clinical Research Coordinator manages the overall conduct of the study, including patient recruitment and compliance. Both roles require similar educational backgrounds but differ in scope and responsibilities within the clinical research process.

What are the most commonly searched types of Clinical Study jobs in Raleigh, NC?

The most popular types of Clinical Study jobs in Raleigh, NC are:

Clinical Study Assistant jobs near you
Infographic showing various Clinical Study Assistant job openings in Raleigh, NC as of August 2026, with employment types broken down into 2% As Needed, 78% Full Time, 13% Part Time, and 7% Contract. Highlights an 84% Physical, 1% Hybrid, and 15% Remote job distribution, with an average salary of $40,905 per year, or $19.7 per hour.

Study Start Up Specialist/Sr. Study Start Up Specialist

Ergomed

Raleigh, NC • On-site, Remote

Full-time

This job post has expired 1 day ago. Applications are no longer accepted.

Job description

Company Description
Medicine moves forward here. So will you.
Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studies where experience, judgement, and rigorous operational accountability make the biggest difference. We partner with small to midsize biotech companies to move promising therapies through early phase development, so they reach the patients sooner.
We choose complex work on purpose. Rare disease and oncology trials carry real operational risk, and our people are experts at reducing it, protecting timelines, data quality and the experience of sites and patients at the same time. It is demanding, meaningful work, and no one here forgets that patients cannot wait.
That is why culture matters to us as much as capability. We have built a collaborative, international team where people share ideas, grow their careers and are trusted to take ownership early. With colleagues across North America, South America, Europe, Asia and Australia, we value teamwork, flexibility and a real commitment to work-life balance, because good science comes from people who feel supported.
If you want work with purpose, the agility to make an impact and a team that cares about the people behind the work as much as the work itself, we would love to hear from you.
Job Description
Study Start Up Specialist coordinates and oversees all activities related to achieving the goal of site activations in accordance with the contract, trial protocol and other study specific requirements, ICH-GCP, all applicable SOPs and regulatory requirements. Study Start Up Specialist takes leadership and acts as the primary point of contact for Sponsor and internal stakeholders during the study start-up process.
Role and Responsibilities
  • Assume leadership during study Set-up process ensuring development of start up strategy, effective and rapid coordination and management of regulatory deliverables, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
  • Serve as main point of contact for all project-specific Study Start-Up activities.
  • Provide regulatory strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures. Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures.
  • Prepare, collect, review regulatory information to support regulatory submissions for initial authorization and maintenance, in compliance with all applicable regulations.
  • Collect, review for completeness and compliance, and track essential documents for Study Start-Up to facilitate efficient site initiation and activation. Investigate incomplete, inaccurate or missing documents to ensure accuracy and completeness of information. Prepare study team reports or updates regarding status of essential document collection, review and approval.
  • Actively correspond with selected sites for updates regarding essential document completion, Informed Consent Form (ICF) development on site level (if applicable) and Institutional Review Board (IRB)/Independent Ethics Committee (IEC) submissions/approvals.
  • Coordinate with study teams, sponsors, clinical monitoring, clinical contracts and/or other functional areas on the priority and processing of documents leading to investigational product release, site activation and site initiation.
  • Take ownership in contract negotiations with investigative sites or coordinate other team members assigned to perform contract negotiations as per study specific RACI (Note: activity supported by other team members as per study contract or study specific RACI; e.g. Legal, CTM, Monitor etc.).
  • Assist with feasibility and site identification activities as needed.
  • Arrange for and/or review translation of essential documents as required.
  • Attend project team meetings and training sessions according to project and/or Sponsor requirements.
  • Ensure all relevant documents are submitted to Trial Master File (TMF) for filing as per study specific guidance.
  • Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated, monitor project budgets, hours spent vs budgeted and promptly identify and escalate any OoS.
  • Support, mentor and train department staff and new-hires.
  • Provide support to proposal development and input to budgets, provide department representation to BD meetings as required.
  • Assist with development and implementation of trainings and SOPS/practice improvements.

Qualifications
education, qualifications and professional memberships
Bachelor's Degree in Chemistry or Life Sciences, Nursing or equivalent experience
EXPERIENCE
  • Minimum 5 years within pharmaceutical/CRO industry
  • Proven ability to successfully manage multi-country projects in start-up

SPECIAL SKILLS
  • Excellent organizational and management skills
  • Strong planning, strategizing, managing, progress monitoring, scheduling, problem-solving and critiquing skills
  • Good interpersonal skills in a fast-paced, deadline oriented, and changing environment
  • Excellent self-motivation and motivation skills
  • Outstanding knowledge of ICH GCP across all areas
  • LANGUAGE SKILLS
    English both oral and writing
  • PC SKILLS
    Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint

Additional Information
When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You'll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.
  • Quality: we hold ourselves to the standard patients deserve.
  • Integrity and trust: we do the right thing, especially when it is hard.
  • Drive and passion: we care about the outcome, because someone is waiting on it.
  • Agility and responsiveness: we move quickly, because patients cannot wait.
  • Belonging: everyone is welcome, and every voice counts.
  • Collaborative partnerships: we go further by going together.

We look forward to welcoming your application.
U.S. Hiring Locations:
Florida, Georgia, South Carolina, North Carolina, Virginia, New York, Tennessee, Texas, Ohio,
#LI remote
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About ERGOMED

Sourced by ZipRecruiter

Industry

Medical equipment and supplies manufacturing

Company size

1 - 10 Employees

Headquarters location

San Antonio, TX, US

Year founded

1987

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