Clinical Research Coordinator

DermCare Management; Plantation (FL); On-site; USD 50,000 - 70,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Retirement plan (401k)

Paid time off

Holidays

Job summary

DermCare Management seeks a Clinical Research Coordinator to lead and manage clinical trials, ensuring GCP and FDA regulatory compliance. The role works closely with investigators, sponsors, and participants to maintain data integrity and participant safety.

Responsibilities include patient visits, sample collection, ECGs, data entry, and coordination of study procedures, with emphasis on confidentiality and adherence to SOPs. Oncology or medical device trials preferred; Spanish skills a plus.

Qualifications

• High School Diploma or GED required. Bachelor's/Master’s preferred.
• Experience conducting clinical trials and ensuring regulatory compliance.
• CCRC certification a plus; phlebotomy experience helpful.

Responsibilities

• Lead and manage clinical trials under PI and Site Manager.
• Conduct patient visits and collect samples (blood/urine); perform ECGs and vitals.
• Administer questionnaires and other participant materials as per protocol.
• Schedule visits, assessments, and procedures to meet study requirements.
• Maintain accurate case report forms; ensure FDA compliance through records.
• Manage clinical data entry while maintaining confidentiality.
• Monitor participants and ensure adherence to study guidelines.
• Handle investigational medications: receipt, dispensing, drug accountability.
• Collaborate with laboratories for processing and review of reports.
• Recruit and screen study participants; maintain regulatory documentation.

Skills

Attention to detail

Organizational skills

Excellent communication

Teamwork

Problem-solving

Spanish (bi-lingual)

Education

High School Diploma or GED

Bachelor’s or Master’s degree in related field (preferred)

Tools

Phlebotomy certification

Clinical trial databases

Job description

The Clinical Research Coordinator leads and manages clinical trials in compliance with regulatory standards, working closely with the investigative team, pharmaceutical sponsors, and research participants. This role requires a strong medical background, proficiency in Good Clinical Practices (GCP), FDA regulations, and a commitment to ethical research standards.

Key Responsibilities

Duties will include, but are not limited to:

• Manage and oversee the execution of clinical trials under the direction of the Principal Investigator and Site Manager.
• Conduct patient visits and ensure adherence to study protocols, collecting and processing biological specimens (blood/urine) and performing procedures such as ECGs and vital signs monitoring.
• Administer questionnaires, diaries, and other participant materials as per protocol.
• Schedule and coordinate research visits, assessments, and procedures, ensuring all requirements are met.
• Maintain accurate case report forms, cross-referencing patient medical records for completeness and FDA compliance.
• Collect, enter, and manage clinical data while maintaining confidentiality.
• Monitor study participants, ensuring adherence to study guidelines and ethical standards.
• Manage investigational medications, including receiving, dispensing, and performing drug accountability.
• Collaborate with laboratories to process, ship, and ensure review of investigational reports.
• Actively participate in recruiting and screening study participants.
• Maintain organized records of study materials, ensuring all regulatory documentation is up to date.
• Ensure necessary supplies and equipment are available and functional for each study.
• Complying with company policies, HIPAA, OSHA regulations, and Standard Operating Procedures (SOPs) to deliver high-quality services.

Qualifications

• High School Diploma or GED
• Preferred: Bachelor’s or master’s degree in a related field.
• Required: Previous experience conducting clinical trials, including recruitment and compliance with regulatory guidelines.
• Preferred: Certification as a Clinical Research Coordinator (CCRC).
• Phlebotomy experience and certification where required.
• Strong knowledge of medical terminology, clinical trial processes, and industry regulations.
• Proficient with computer hardware and software, including clinical research databases.
• Proficient in accessing, inputting, and retrieving data from a computer.
• Strong attention to detail and organizational skills.
• Ability to prioritize tasks, manage deadlines, and adapt to changing environments.
• Ability to receive and process information through both oral and written communication.
• Excellent problem-solving, leadership, and communication skills.
• Outstanding interpersonal skills, with the ability to establish and maintain effective relationships with patients, investigators, and external partners.
• Ability to work both independently and collaboratively as part of a team.
• Ability to maintain confidentiality and handle sensitive information.
• Willingness to learn and stay updated on new clinical research trends and regulations.
• CCRC certification a plus.
• Bi-lingual in Spanish is a plus.

Benefits

• Medical Insurance
• Dental Insurance
• Vision Insurance
• Supplemental health benefits
• Paid time off
• Holidays
• Retirement plan (401k)

Physical Demands and Work Environment

• Ability to sit or stand for 6-8 hours a day and lift or carry 5-10 pounds occasionally.
• Requires substantial use of wrists, hands, and fingers for tasks such as typing and filing.
• This position operates primarily in a professional office/clinical environment. The role regularly requires sitting, working at a computer, communicating with employees and managers.