ESSENTIAL DUTIES AND RESPONSIBILITIES

The Clinical Research Coordinator will be assigned to pharmaceutical studies, device clinical trials, and/or investigator-initiated research projects. This position works under the supervision of Principal Investigator(s) and Director, Clinical Research Operations whose research activities are conducted under good clinical practice (GCP) guidelines. Work hours will need to be flexible to meet individual project needs. Evening, weekend, and overnight hours may be required. Attendance at departmental and weekly general staff meetings is expected. This is not a fully remote position and while some remote work may be permitted at times, consistent in-person attendance is required.

This position will fulfill the following specific functions:

1. Responsible for the integrity and overall quality of assigned clinical research trials
2. Responsible for organizing and leading assigned studies
3. Communicates with the sponsor’s site monitors, Clinical Research Associates (CRAs), and local and/or central Institutional Review Boards (IRBs)
4. Prepares, schedules, and leads and/or participates in study visits with monitors, sponsors, and auditors
5. Trains Clinical Research Assistants and Ambassadors on studies, policies, procedures, and other topics as appropriate
6. Follows GCP regulations, state and local laws, and study protocols
7. Participates in the Informed Consent process, potentially including drafting, amending, and conducting Informed Consent visits with study subjects
8. Reviews protocols to ensure each study fits with the SDRI mission statement and that we can actively recruit the required subject population and conduct the study successfully
9. Create and maintain source documents
10. Completes Case Report Forms (CRFs) for assigned studies and enters electronic data as required by the study
    1. CRFs will be completed and up-to-date prior to site monitor visits
    2. Changes or corrections noted by the monitors will be completed before the next scheduled monitor visit date or as specified by the sponsor’s deadline
11. Completes and submits Adverse Event (AE) forms per protocol and regulatory guidelines and Serious Adverse Events (SAE) forms to the sponsor and the IRB within 24 hours of SAE occurrence
12. Supervisees recruitment process for assigned studies, screens potential subjects, and conducts subject visits
13. Establishes and maintains relationships with study subjects and participates in subject education regarding the clinical trial process, and provides specific trial information to each subject/volunteer
14. Completes regulatory documents for assigned studies, including submission for IRB initial approval and applicable renewals
15. Attends Investigator Meetings as assigned
16. Maintains drug and device accountability and dispensing logs for assigned studies
17. Clinical duties include, but are not limited to:
    1. Completion of comprehensive medical history for study subjects
    2. Measure vital signs, weight, and height of study subjects per protocol and reports any abnormal results to the Principal Investigator or sub-Investigator
    3. Phlebotomy and blood sample processing according to universal bloodborne pathogen precautions
    4. Recording 12-lead ECGs per protocol
    5. Providing ongoing patient education
    6. Ordering outside laboratory tests and/or procedures on an as-needed basis
18. Laboratory duties include:
    1. Centrifugation of blood samples
    2. Processing and packaging of body fluid samples (including but not limited to blood, urine, and saliva)
    3. Proper sample storage
    4. Proper shipment of samples, including contacting the appropriate courier
19. Maintains cleanliness and order in all of the designated areas during studies. Complies with Safety Committee policies and recommendations
20. Assists with medical writing as appropriate and assigned, including protocols, scientific papers, and grant writing
21. Supports Clinical Trial Business Manager in staffing and scheduling for studies as appropriate
22. Assists Clinical Trial Business Manager as needed with study contracts and budgets
23. Other duties as assigned by superiors

SUPERVISORY RESPONSIBILITIES

Incumbent will supervise Clinical Research Ambassadors and Clinical Research Associates I-II.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. 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 essential functions.

• Basic knowledge of accepted clinical research practices, including universal precautions, human subjects research protocols and HIPAA requirements
• Knowledge of drug development process, ICH guidelines and FDA CFRs
• Ability to lead pivotal studies independently
• Ability to handle 3 or more studies simultaneously and effectively delegate tasks to Clinical Research Assistants
• Ability to work independently and with careful attention to detail as well as in collaboration with other staff members
• Basic knowledge of office practices and office equipment
• Basic knowledge of computer systems for word processing, electronic mail, data entry, and electronic data transfer
• Basic typing skills
• Excellent multi-tasking, prioritization, communication, and organizational skills and ability to work under stress
• Ability to transfer and record data accurately, in the required format, and in a timely manner
• Must be able to establish rapport and communicate with subjects of diverse cultural and educational backgrounds.
• Interpersonal skills, public speaking, and report writing abilities
• Ability to understand and carry out instructions in written, oral, or diagram form
• Proven ability to deal with problems with several variables and ability to prioritize tasks and activities in a manner consistent with direction from supervisor
• Ability to think and reason critically
• Strong managerial skills and ability to support, train, and supervise subordinates as well as effectively manage and troubleshoot issues as appropriate

EDUCATION AND EXPERIENCE

• Experience working in a medical setting
• At least three years of experience working in clinical research
• High school diploma and Bachelor’s degree or equivalent experience
• Scientific or nursing education desirable
• Phlebotomy skills desired
• ACRP CCRC certification highly desirable

LANGUAGE SKILLS

The ability to read, write and speak English clearly is required. The ability to interpret documents such as safety rules, SOPs, and procedures is critical and an understanding of and ability to communicate in scientific language is desired. Spanish proficiency and/or fluency highly desired.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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 is 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 manual dexterity, skill level and adequate vision to record data onto data sheets and adequate hearing and verbal communication skills to converse with study subjects. Standing for extended periods of time as well as light lifting is necessary.

The incumbent must be in sufficient overall health to report for work consistently and reliably and work through a standard day with appropriate breaks.

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.

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.