What are the responsibilities and job description for the Clinical Research Manager position at Solaris Health Holdings LLC?
GENERAL SUMMARY
The Clinical Research Manager manages the clinical monitoring process and the administration of clinical trials.
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:
- Ensuring compliance with regulations and protocols
- Orients new staff and assures that training and education needs of staff are met.
- Manages all clinical research staff to ensure optimal performance on each study.
- Evaluates activities of department to ensure patient care, staff relations, and efficiency of service.
- Ensures all studies are conducted to FDA regulations and, GCP guidelines
- Develops, implements, and evaluates department policies, goals, and objectives.
- Ensures study start up documents are submitted to ethics committee and sponsor in timely manner.
- Directs preparation and maintenance of patients' clinical records. ? Investigates and resolves complaints or refers unusual problems to superior.
- Supervises CRAs in in-house and on-site monitoring, filing, and clinical trial administration.
- Oversees adherence to SOPs, Good Clinical Practice and FDA regulations.
- Helps with the development and implementation of clinical processes, procedures, and programs.
- Conducting scientific investigations and data analysis. ? 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:
- Research Professionals (ACRP).
- License and certification as required by state.
- Job Title: Clinical Research Manager Pay Grade: FLSA Status: Exempt Job Family: RESRCH Version: 11.27.24 Job Code: 14003 KNOWLEDGE | SKILLS | ABILITIES ? E
- Excellent verbal and written communication skills. ? Strong analytical and problem-solving skills. Complies with HIPAA regulations for patient confidentiality.
- Complies with all health and safety policies of the organization.
- Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
- Ability to write speeches and articles for publication that conform to prescribed style and format.
- Skill in using computer programs and applications including Microsoft Office.
- Ability to work independently and manage deadlines.
EDUCATION REQUIREMENTS
Bachelor’s degree in a related field, such as biology, health science or research required. Masters degree preferred.
EXPERIENCE REQUIREMENTS
Three to five years related experience and/or training; or equivalent combination of education and experience.
