Job Description

GENERAL SUMMARY

Clinical Research Coordinator, RN’s are primarily responsible for study coordination and data management, with a central focus on managing subject recruitment and enrollment, consistency of study implementation, data management and integrity, and compliance with regulatory requirements and reporting.

Requirements

ESSENTIAL JOB FUNCTION/COMPETENCIES

The responsibilities and duties described in this job description are intended to provide a general overview of the position. Duties may vary depending on the specific needs of the affiliate or location you are working at and/or state requirements. Responsibilities include but are not limited to:

• Maintain site compliance for all clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements.
• Maintain working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s).
• Complete all relevant Profound Research required training, including but not limited to ICH-GCP certification and IATA certification in a timely manner.
• Educates and directs protocol compliance with physicians and staff.
• Assists in developing tools to meet requirements of new protocols.
• Manages protocols with increased clinical complexities including translational investigator-initiated research as well as multi center trials.
• Ensure good documentation practices are applied by all team members when collecting, maintaining, and correcting study data and required records of clinical trial activity including but not limited to source documentation, case report forms, queries, drug dispensation records, and regulatory forms.
• Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.
• Acts as a patient advocate by providing education to and responding to questions from patients about protocols.
• Works with patients to ensure adherence with the protocol.
• Collaborates with scheduling staff to assure that future appointments for the patients (follow up visits and diagnostic testing) are scheduled correctly and timely.
• Collaborates with the physician to assure orders for treatment are written per protocol and delivered at the prescribed protocol intervals.
• Performs other position related duties as assigned.
• Employees shall adhere to high standards of ethical conduct and will comply with and assist in complying with all applicable laws and regulations. This will include and not be limited to following the Solaris Health Code of Conduct and all Solaris Health and Affiliated Practice policies and procedures; maintaining the confidentiality of patients' protected health information in compliance with the Health Insurance Portability and Accountability Act (HIPAA); immediately reporting any suspected concerns and/or violations to a supervisor and/or the Compliance Department; and the timely completion the Annual Compliance Training.

CERTIFICATIONS, LICENSURES OR REGISTRY REQUIREMENTS

• BLS certification required, ACLS preferred.
• RN licensure and certifications as required by State.
• Clinical research certification from SoCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals) preferred.

KNOWLEDGE | SKILLS | ABILITIES

• Ability to Start IVs and Administer IV medications
• Ability to draw blood
• Understanding of all aspects of biomedical research protocols, ensuring applicable regulations, and guidelines.
• Maintains patient confidentially.
• Excellent verbal and written communication skills.
• Skill in using computer programs and applications.
• Maintains current knowledge and awareness of organizational and regulatory standards, policies and procedures.
• Excellent organizational skills and attention to detail.
• Ability to build relationships with patients and display empathy and compassion to patients
• Skill in using computer programs and applications including Microsoft Office.
• Complies with HIPAA regulations for patient confidentiality.
• Complies with all health and safety policies of the organization.

EDUCATION REQUIREMENTS

• Must be a Registered Nurse (RN) with a current and valid license. Associate’s or Bachelor’s degree in Nursing (ASN or BSN) required.

EXPERIENCE REQUIREMENTS

• 2 or more years Nursing experience in ICU, ER, oncology or clinical trial experience, preferred.

REQUIRED TRAVEL

• May require travel to other site locations in practice.
• May require travel to Investigator and other meetings.

PHYSICAL DEMANDS

Carrying Weight Frequency

1-25 lbs. Frequent from 34% to 66%

26-50 lbs. Occasionally from 2% to 33%

Pushing/Pulling Frequency

1-25 lbs. Seldom, up to 2%

100 + lbs. Seldom, up to 2%

Lifting - Height, Weight Frequency

Floor to Chest, 1 -25 lbs. Occasional: from 2% to 33%

Floor to Chest, 26-50 lbs. Seldom: up to 2%

Floor to Waist, 1-25 lbs. Occasional: from 2% to 33%

Floor to Waist, 26-50 lbs. Seldom: up to 2%

Version 6.2.25