Clinical Research Manager

Articularis Healthcare Group Inc; Summerville (SC); On-site; USD 42,000 - 64,000; Full time

Benefits offered by this job

4-day work week

Benefits package including medical,3—d

Job summary

Articularis Healthcare Group in Summerville, SC is seeking a full-time Clinical Research Coordinator to support regulatory filings, trial start-up, and ongoing study data management.

You will prepare FDA 1572 forms, assist with IND submissions, coordinate IRB activities, monitor safety data, ensure HIPAA compliance, and maintain Investigator Site Files while supporting patient recruitment and site operations.

Qualifications

• Associates degree with 2 years' experience in a medical/clinical setting.
• Experience with regulatory documentation and FDA processes.
• Strong verbal and written communication.

Responsibilities

• Prepare regulatory documentation for study start-up (FDA 1572, IND, IRB).
• Coordinate regulatory activities and day-to-day site operations.
• Track licenses, CVs, and staff documentation.
• Maintain safety reports and data queries.
• Ensure HIPAA compliance and patient confidentiality.
• Support monitor visits and audits.
• Assist with patient recruitment strategies.

Skills

Regulatory docs

HIPAA compliance

Communication skills

Education

Associates degree

Tools

Microsoft Office

Job description

• Location 2001 2nd Avenue,Suite 201,Summerville, SC, 29486,United States

Articularis Healthcare Group (AHG) is currently seeking a full-time Clinical Research Coordinator. This position is located in Summerville, SC. This position is an interim role, up to 20 hours per week with the potential to become full-time and permanent in the future.

Who We Are:

Articularis Healthcare Group, Inc. (AHG) is an independent physician-led, clinically integrated, group of medical professionals who use the latest clinical innovations to provide compassionate and exceptional patient care. We are committed to helping patients, people, and medical practices thrive.

What Sets Us Apart:

• We are physician-led.
• We make decisions together.
• We’re independent by design.

Our Mission:

Delivering the highest quality community-based rheumatology services with a commitment to patient care, physician leadership and excellence. Our core values are
Compassion ,
Integrity ,
Quality ,
Respect
and
Teamwork .

The Clinical Research Coordinator will be responsible for the preparation, submission, and maintenance of clinical trials and regulatory data.

As a Clinical Research Coordinator, typical duties might look like:

• Prepares regulatory documentation for all study start-up at site, including FDA 1572 forms, IND filings and IRB's.
  
• Responsible for coordinating and maintaining the regulatory and day to day site activities.
  
• Tracks expirations and retrieves current documentation for medical licenses, CVs, laboratory accreditation for all site staff.
  
• Responsible for the reporting, monitoring, distribution, and maintenance of files for all safety information related to ongoing clinical trials.
  
• Responsible for posting and maintaining regulatory documents including protocols, amendments, consent forms, IB, sponsor/CRO communication.
  
• Tracks and ensures all training and regulatory documents such as delegation logs are up to date in all Investigator Site Files.
  
• Develops and implements patient recruitment strategies and standard operating procedures.
  
• Reviews new/proposed protocols and prepares written reports as to operational feasibility.
  
• Maintains patient confidentiality through HIPAA compliance and ensures any release of patient information is done in accordance with the company guidelines.
  
• Manages logistical aspects of studies and assesses study protocols.
  
• Regularly supports the site staff as needed,
  
• Ensures participant informed consent is obtained.
  
• Performs study procedures in accordance with GCP, IATA certification, OSHA guidelines (lab draws/processing, vital signs,
• EKG, subcutaneous injections, dispense study medications, manage, and monitor the use of study electronic devices, etc.).
  
• Collects, maintain, and submit study data in a timely manner.
  
• Ensures accuracy of study documentation to avoid queries.
  
• Submits study specific reports (these reports may include but are not limited to: serious adverse events, protocol deviations, screening logs, database updates, and annual renewal reports).
  
• Coordinates and prepares for monitor / audit visits.
  
• Works effectively and cooperatively with colleagues to provide back-up coordination as required.
  
• Other duties as assigned by manager. including travel to Investigator meetings and attend monthly sponsor teleconference.
• Other Duties as assigned

This job might be for you if possess the following:

• Associates degree with 2 years or any combination of education and work experience.
• Previous experience working in a medical/clinical setting.
• Working knowledge of computers, internet access, and the ability to navigate within Microsoft Office Suite, or similar programs.
• Demonstrated excellent verbal and written communication skills.

Why you should apply:

Joining our AHG team will provide you with a positive team environment, growth and advancement opportunities, as well as a work/life balance. With our office hours of Monday through Thursday, you will be able to enjoy your nights and 3-day weekends with family and friends.

• 4-day work week
• Benefits package that includes group medical, dental, vision, short-term & long-term disability insurance, paid holidays, PTO and 401K.

EEO/AA-M/F/disabled/protected veteran

*Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function