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Clinical Research Coordinator

Culver City, CA 90230

Posted: 03/24/2023 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 547319 Is job remote?: No Country: United States

Job Description


POSITION OVERVIEW 

The Clinical Research Coordinator fulfills the requirements of recruiting, screening, enrolling and  conducting the follow-up of study participants in clinical trials under the supervision of the Principal  Investigator (PI) and Project Manager. In doing so, the Clinical Research Coordinator is responsible for  coordinating trial participation of study volunteers with the trial’s protocol, company and trial Standard  Operating Procedures (SOPs), Good Clinical Practice (GCP)/ International Conference on Harmonization  (ICH) guidelines, FDA regulations and other applicable regulations (global, state, etc.). The Clinical  Research Coordinator is responsible for working with the trial delivery team to meet enrollment and  retention goals and ensure compliance with the study protocol. 

DUTIES AND RESPONSIBILITIES 

Duties include but are not limited to: 
  1. Actively participates in the implementation and execution of clinical trial activities from study  start-up preparations, planning, execution and closure. 
  2. Attends investigator, project and department meetings/trainings, and leads as needed, and  assist in gathering agenda topics and creating meeting minutes as required. 
  3. Participates as temporary Project Manager for smaller studies, as needed, with appropriate  training/support. 
  4. Under direct supervision of a Principal Investigator, is responsible for enlisting, maintaining, and  ensuring protocol compliance for all study participants in clinical trials. 
  5. Collaborates with study investigators to determine eligibility of potential participants in clinical  trials. 
  6. Screens potential participants for protocol eligibility. Presents trial concepts and details to the  participant, participates in the informed consent process, and enrolls participants in study  protocol. 
  7. Ensures research quality by practicing in compliance with and advocating for any edit needs of Standard Operating Procedures (SOP), and ensures research quality by practicing in  compliance with principles of Good Clinical Practice (GCP) and applicable federal, state, and local  regulations. 
  8. Supports the development, review and distribution of clinical protocols, informed consent  forms, study instructions/manuals/guidelines or department generated tools and other study related clinical documents.  
  9. Coordinates patient care in compliance with protocol requirements. May provide participants  education regarding medication administration. Maintains individual participant investigational  drug accountability. 
  10. In collaboration with the study investigator, reviews study participants for changes in condition,  adverse events, concomitant medication use, protocol compliance, response to study drug and  thoroughly documents all findings. 
  11. Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities
  12. Maintains comprehensive knowledge of assigned research protocol to coordinate the  comprehensive and compliant execution of assigned protocols in accordance with research  governing entity requirements, including but not limited to Sponsor, FDA, and IRB requirements.  
  13. Ensures the completion and maintenance of consent forms, case report forms, SAE’s and source  documents to ensure that research is being conducted according to guidelines. 
  14. Establishes and coordinates logistical aspects of clinical research projects to achieve project  objectives. 
  15. Supports the maintenance of regulatory documents in the ISF in accordance with SOPs and  applicable regulations. 
  16. Participates in required training and education programs. Assists with education of other  personnel and vendors regarding clinical research. 
  17. Collaborates closely with Project Manager to ensure compliance to trial procedures and vendor  management. 
  18. Provides process improvement solutions and collaborates on the implementation of the solutions.
  19. Additional responsibilities may include working directly with other vendors and/or sponsors. 
  20. Provides a safe environment for study participants, caregivers, and study personnel at all times through compliance with all federal, state, and professional regulatory standards. Maintains strict  patient confidentiality according to HIPAA regulations and applicable law. 

DUTIES AND RESPONSIBILITIES FOR HYBRID TRIALS 
  1. Act as point of contact for the site and Sponsor, as necessary, with oversight from the Project  Manager. 
  2. Assist in developing project plan, outlining planning, execution and closeout processes.
  3. Assist in developing the study communication plan in collaboration with the sites.
  4. Collaborate with the study team and extended members to ensure compliance to  trial procedures.  
  5. Other duties, as assigned. 

COMPREHENSIVE DUTIES 
  1. Act as point of contact for the site and Sponsor, as necessary, with oversight from the Project  Manager. 
  2. Develop project plan outlining planning, execution and closeout processes. 
  3. Develop the study communication plan in collaboration with the sites. 
  4. Collaborate with the study team and extended members to ensure compliance to  trial procedures.  
  5. Collaborate with multi-disciplinary teams to provide clear direction and processes for  site study teams and assist with study execution. 
  6. Other duties, as assigned. 

QUALIFICATIONS & SKILLS 

Qualifications  
  1. Bachelor’s degree (preferred) or minimum two-year college degree, or an equivalent combination of education, training, experience, and demonstrated skills needed to successfully perform the  assigned duties and responsibilities.
  2. Minimum of 3 years relevant investigational research experience in the clinic or  pharma/biotech/CRO. 
  3. ACRP (CCRC) or SoCRA (CCRP) certification, highly desired 
  4. Medical and scientific knowledge, preferred. 
  5. Experience working with patients in a HIPAA regulated environment and knowledge of good clinical practice (GCP), and applicable regulatory requirements.
  6. Excellent time management, organizational skills and ability to manage multiple tasks. 7. Attention to detail and accuracy in work.
  7. Must have the ability to conduct collaborative interaction with cross functional team members.

Skills/Competencies 
  1. Expertise in trial management - The ability to successfully manage participants in clinical trials.  Proactive problem-solving abilities and follow through.  
  2. Working Knowledge of FDA regulations and GCP guidelines – Understands applicable  regulations, guidelines and implications for trial participation. 
  3. Working knowledge of clinical research - Knowledgeable about the critical elements for success  in clinical trials; participation in and contribution to these activities.  
  4. Strong communication and presentation skills - Demonstrates strong written and verbal  communication and presentation skills. Ability to establish and maintain cooperative working  relationships with study participants and project team members  
  5. Computer skills - Working knowledge of MS Office suite, Electronic Data Capture Systems, Google  applications. Ability to generate business correspondence, create forms and generate reports as  required. Willingness to gain expertise in the use of proprietary software.  
  6. Practices professionalism and integrity in all actions – Ability to foster concepts of teamwork,  cooperation, social and self-awareness, and flexibility to get complete assigned tasks.  Demonstrates adaptation to a rapidly changing work environment. Able to successfully work in a  decentralized team environment. Skilled in situational responsive decision-making. 

Capabilities  
  1. Up to 20% travel, as needed, for study visits, training, project team meetings, client presentations  and other professional meetings/conferences as needed 
  2. Ability to communicate in English (both verbal and written); fluency in other languages is a plus. 3. May require extended or unusual work hours based on research requirements and business  needs.  
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