Clinical Research Coordinator

Job Title:                          Clinical Research Coordinator

Department:                    Clinical Research

Reports to:                        Clinical Trial Manager

FLSA Status:                    Full Time Non-Exempt

ESSENTIAL DUTIES AND RESPONSIBILITIES

The Clinical Research Coordinator may be assigned to pharmaceutical studies, device clinical trials and/or investigator-initiated research projects. This position works under the supervision of a principal investigator and Clinical Trial Manager whose research activities are conducted under good clinical practice (GCP) guidelines:

• Responsible for the integrity and overall quality of assigned Clinical Research trials
• Responsible for organizing and taking charge of assigned studies.
• Communicates with the sponsor’s Site Monitors, Clinical Research Associates (CRAs), and local or Central Institutional Review Boards (IRB).
• Prepares, schedules and participates in study visits with monitor, sponsors, and auditors.
• Follows GCP regulations, state and local laws, and current study protocols.
• Participates in the Informed Consent process.
• Reviews protocols to ensure the study fits with our Mission statement and that we can actively recruit the required population
• Create and maintain Source Documents.
• Completes Clinical Research Forms (CRFs) for assigned studies and enters electronic data as required by the study.
  • CRFs will be completed and up to date prior to the Site Monitor visits.
  • Changes or corrections noted by the monitors will be completed before the next scheduled monitor date or as specified by the sponsor’s deadline.
• Completes and submits all Serious Adverse Event (SAE) forms to the Sponsor and the IRB within 24 hours of completion.
• Recruits and screens potential research subjects and conducts subject visits.
• Establishing relationships with patient volunteers, and participating in patient education regarding the clinical trial process and providing specific trial information to the participant as well as conducting the informed consent process.
• Completes regulatory documents for assigned studies, including submission for IRB initial approval and IRB renewals for assigned studies.
• Attends Investigator Meetings as assigned.
• Maintains drug and device accountability and dispensing for assigned studies.
• Clinical Duties include:
  1. Completion of comprehensive medical history for study subjects
  2. Measure vital signs, weight and height of study subject as required by the protocol.

(Abnormal vital signs must be reported directly to the Principal Investigator or co-

Principal Investigator)

1. Phlebotomy using universal bloodborne pathogen precautions.
2. Recording 12-lead ECGs per protocol
3. Providing ongoing patient education.
4. Ordering outside labs and/or procedures on an as-needed basis.

• Laboratory duties include:
  1. Centrifugation of blood samples
  2. Processing and packaging of samples. (Samples may include body fluids other than blood)
  3. Proper storage of samples
  4. Proper shipment of samples, including contacting the appropriate courier.
• Maintains cleanliness and order in all of the designated areas during the study. Complies with Safety Committee policies and recommendations.
• Assists with IND, scientific papers, and grant writing.
• Other duties as assigned by the immediate Supervisor.

SUPERVISORY RESPONSIBILITIES

Bench Staff Research Assistants and Volunteer Ambassadors

HOURS OF WORK

Work hours will need to be flexible to meet the project needs. Evening, weekend and overnight work may be required. Attendance at departmental meetings and weekly general staff meeting is expected. This is not a telecommuting position and consistent attendance is required. 

QUALIFICATIONS

The incumbent must be able to perform each essential duty satisfactorily. Appropriate training will be provided where necessary, and specific assistance in refreshing the incumbent in those areas where appropriate. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

1. Basic knowledge of accepted Clinical Research practices, including universal precautions, human subjects research protocols, and HIPAA requirements
2. Knowledge of drug development process, ICH Guidelines and FDA CFR’s
3. The ability to handle 3 or more studies simultaneously
4. Ability to work independently and with careful attention to detail.
5. Basic knowledge of office practices and office equipment.
6. Basic knowledge of computer systems for word processing, electronic mail, data entry, and electronic data transfer
7. Basic keyboarding skills.
8. Excellent communication skills both oral and written
9. Must be able to establish rapport and communicate with clients of diverse cultural and educational backgrounds.
10. Interpersonal skills, public speaking and report writing
11. The ability to interpret documents such as safety rules, operating and maintenance instruction, and procedure manuals is necessary.
12. The ability to communicate information to other employees as well as management in a clear and concise manner is essential.

EDUCATION AND EXPERIENCE

• Bachelor’s degree, Nursing degree or an appropriate combination of education and experience to perform the essential duties is required.
• 1 to 2 years experience working in a clinical setting, including experience in Clinical Research, desirable. 
• Phlebotomy skills highly desirable.
• CCRC certification highly desirable.

LANGUAGE SKILLS

• Ability to read, write, and speak the English language fluently is required.
• Ability to read, write, and speak the Spanish language fluently is preferred. 

REASONING ABILITY

• The ability to understand and carry out instructions in written, oral, or diagram form.
• The ability to deal with problems involving several variables in standardized situation must be a proven ability.
• The ability to prioritize tasks and activities in a manner consistent with direction from supervisor. 
• The ability to use critical thinking skills when necessary.  

PHYSICAL DEMANDS

The incumbent is regularly required to sit, talk, hear, and climb stairs. The incumbent frequently is required to use hands to finger, handle or feel equipment, paper, or files. The incumbent must be able to operate a computer keyboard as well as see a computer monitor display screen. The incumbent is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10-20 pounds. Specific vision abilities required by this job include close vision.

This position requires the manual dexterity, skill level and adequate vision to perform phlebotomy, recording of data onto data sheets and entering data into a computer; and adequate hearing and verbal communication skills to conduct interviews (in person or on the telephone).  Standing for extended periods of time as well as light lifting is necessary.  Substantial use of a computer.  Moderate use of the telephone.

The incumbent must be in sufficient overall health to report for work consistently and reliably and work through a standard day with appropriate breaks. Periodically, extended work hours and travel extending over several days are required.   

WORK ENVIRONMENT

The work environment would be generally described as an office setting with clinical facilities adjacent to the primary work area and laboratory facilities on a different floor. The ability to move within all three of these areas may be required in the execution of the employee’s functional activities. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate and the illumination of the work area is primarily with fluorescent artificial lighting.

This position is associated with exposure to biohazardous materials and communicable disease requiring the use of universal precautions at all times as well as other conditions common to a medical clinic and research facility.  Reliable transportation for local travel to off-site clinics will be required. Mileage costs will be reimbursed at the federal standard rate.

This job description is intended to describe the general requirements of the performance of the job. It is not a complete list of duties, responsibilities or requirements. Other duties not listed here may be assigned as needed.