Clinical Research Coordinator

JOB DESCRIPTION: CLINICAL RESEARCH COORDINATOR

POSITION IDENTIFICATION

POSITION TITLE:  CLINICAL RESEARCH COORDINATOR

Reports To: Principal Investigator

Wages: Hourly full-time position commensurate with experience 

**MUST BE AUTHORIZED TO WORK IN THE USA. NO VISA OR WORK SPONSORSHIP AVAILABLE**

FULL TIME

POSITION PURPOSE:

Full-time opportunity to work as a clinical research coordinator. The position would require the individual to administer and coordinate research studies and activities. This position is responsible for direct patient contact providing navigation through the clinical trial enrollment and treatment process. Duties include coordination of patient treatment activities, maintaining and reporting patient study data as required and adhering to established clinical trial protocols. Processing of blood and tissue samples, performing drug accountability, collection of vitals and other medical information, data submission and regulatory adherence in accordance with the FDA and study. The individual will need to maintain record keeping systems in overseeing the research to completion.

DUTIES AND RESPONSIBILITIES:

1. Coordination of study procedures, data management, regulatory management, and follow-up on clinical trials to assure patient treatment, patient scheduling, patient safety, data accuracy, protocol compliance, and regulatory compliance as required by the clinical trial protocol, the study sponsor, and good clinical practice (GCP).

2. Submit study protocol documentation to the IRB, site initiation visits and informed consent process.

3. Work closely with the physicians and office staff and other health care professionals to identify patients for clinical trials.

4. Informed consent process, adverse event monitoring and reporting according to protocol guidelines.

5. Recruits, instructs, and coordinates research subjects and/or volunteers, as

appropriate to specific study objectives and work scope.

6. Work directly with study monitors to resolve protocol and data-related issues. Assist in quality control assurance activities including internal, sponsor, and Federal Drug Administration (FDA) audits.

7. Act as liaison between study sponsors, research networks and regulatory agencies.

8. Partner with Study Regulatory Specialist for continuing study amendment training and to ensure appropriate IRB documentation is in place including approvals, revisions, renewals, and addition of new investigators.

9. Responsible for study-specific investigational drug accountability including ordering, distributing, and return of Investigational drugs to appropriate source as necessary. Ensure that records are being maintained and drug destruction is performed per sponsor and clinic guidelines.

10. Attend meetings as requested and participates in outreach and informational programs to educate community about research opportunities as needed.

11. Regular attendance is an essential job function.

EDUCATION, TRAINING AND COMPETENCIES

EDUCATIONAL REQUIREMENTS:

1. University degree in a related field preferred or equivalent combination of

education and experience. Prior related clinical experience could be considered in lieu of bachelor’s degree requirement.

SPECIALIZED CERTIFICATES/LICENSES:

1. No prerequisite certificates/licenses required—will be required to complete

certification on ethical conduct of research involving human subjects if not already

completed (GCP certification).

TRAINING/EXPERIENCE CLINICAL REQUIREMENTS:

1. Minimum of one year of clinical research experience preferred.

2. Familiarity with community research-based principles.

3. Excellent facilitation skills

4. Excellent communication and interpersonal skills

5. Fluency in English

6. Strong awareness of anti-oppression and harm reduction issues

TRANSFERABLE COMPETENCY REQUIREMENTS:

1. Verbal communications skills

2. Problem-solving skills

3. Planning/organizational skills a must

4. Personal motivation

5. Project Management capabilities

6. Customer service skills

SPECIFIC TECHNICAL COMPETENCY REQUIREMENTS

1. Computer Competency including proficiency in Microsoft Word, Excel and

PowerPoint.

2. Familiarity with data storage and analysis systems and cloud-based databases.

PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS

1. Work is performed at a medical office

2. Travel may be required

3. Exposure to human bodily fluids

4. Subject/Patient Care

5. Extensive Computer Use

6. Occasional night and weekend work schedules

Please submit your resume with a cover letter outlining your interest to:

office@sagermd.com

Job Type: Full-time

Salary: Depends on experience

Expected hours: 38 per week

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• Research experience preferred

Language:

• English (Required)

Work Location: In person

Commitment for at least 2 years