Experienced Clinical Research Coordinator

Job Description

Job Description

EXPERIENCED Clinical Research Coordinator - Onsite

Job Details:

• 15-20 hours/week for the first 3 months.
  Potential to increase to 25 hours to 40 hours after 6 months based on the start date of new studies and enrollment in current studies.
• This job is onsite in Los Angeles.
• Remote work is NOT available for this position.

Position Overview:

• The Greater Los Angeles Veterans Research and Education Foundation (GLAVREF) seeks an enthusiastic Clinical Research Coordinator (CRC) to join our dynamic clinical trials team.
• The CRC will plan, coordinate, and manage all activities associated with the initiation, conduct and completion of assigned clinical trials.
• The CRC supports multiple Phase II-IV clinical trials across a variety of disciplines and investigators which may be sponsored by federal agencies including NIH or DOD and pharmaceutical sponsors or CRO’s.
• The CRC maintains compliance with all regulatory bodies associated with human subject research.

Duties and Responsibilities:

• Works collaboratively with Principal Investigator and clinical staff to identify eligible participants for clinical trials.
• Educates patients and their families to assure that they are informed prior to obtaining written consent.
• Educates affected hospital personnel on the details of the trial(s).
• When required, administer and document informed consent prior to initiation of any study-related activities.
• Prepare patient information for registration/randomization.
• Responsible for follow-up and active patient monitoring per study protocol.
• Obtain/coordinate, process and ship subject blood, cultures, tissues, and other specimens for laboratory analysis as described in the study protocol(s).
• Maintain accurate records of subject drug accountability and assist the Investigational Drug Service (IDS) with the receipt, inventory, and dispensation of study drugs and materials as necessary. Work with the clinical staff to administer study drugs to research subjects when applicable.
• Inspect CRFs, source documentation, and study files to ensure completeness.
• Review CRFs, source documentation, and study files with representatives from the sponsor, Clinical Research Organization (CRO), or Food and Drug Administration (FDA) at each visit. Make necessary corrections to CRFs and submit requested documentation in a timely manner.
• Responsible for obtaining required specimens per the protocol and transport of said specimens to the research office for processing and shipment.
• Comply with standard operating procedures of the sponsor, institutional review board (IRB), and CRO involved with the trial.
• Collects, maintains, and stores all relevant clinical data and case report forms, in accordance with the study sponsor and all regulatory bodies.
• Collects pertinent information and data from subject charts and records, subject interviews, and other sources, while maintaining the highest standards in the protection of VA sensitive information. Create and complete case report forms (CRFs) in accordance with research protocol guidelines.
• Collaborate closely with the investigator and clinic staff in scheduling future appointments and explaining patient questionnaires.
• Update the project Clinical Trials Management system and the GLAVREF CTMS in a timely manner, which includes but is not limited to subject enrollment, patient payments and study milestones.
• Schedule and attend all Site Initiation Visits, Monitoring Visits, Close-Out Visits etc. for all assigned studies/or when asked to attend by the Lead Clinical Coordinator.
• Responsible for preparing the research chart for internal audits.
• Responsible for obtaining required specimens per the protocol and transport of said specimens to the research office for processing and shipment.
• Responsible for evaluation and reporting serious adverse events and expedited reporting of such events if required.
• Responsible for ensuring protocol adherence by understanding, communicating, and making sure the study parameters are ordered and carried out per protocol requirements.
• Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information.
• Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries.
• Report any evidence of research non-compliance in a timely fashion.
• Provides cross-coverage for trials as assigned.
• Presents information at regular research staff meetings.
• Present information and respond to questions from physicians, staff, and patients.
• Obtain all required source documentation.
• Minimal travel is required, CRC will attend management-approved educational conferences and study meetings when available.
• May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities.
• Maintain accurate and timely documentation (I.e. assessments and participant notes using REDCap).
• Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
• Contribute to- or lead peer-review manuscripts (based on interest).
• Comply with VA Research Office and Medical Center education requirements.
• Compile and submit reports, documents, and correspondence as necessary to the IRB, sponsor, and CRO.
• Collaborate closely with the investigator and clinic staff in scheduling future appointments, explaining patient questionnaires.
• Assist with the development and implementation of study protocols.
• Assist the research team in preparation for external audits.
• Any protocol violation/deviation will be reported to the appropriate persons/departments, as needed.
• Other duties as assigned.

Qualifications:

• Bachelor's degree required, Master's Degree preferred, AND a minimum of two years’ experience in a clinical research setting, OR an equivalent combination of education, experience, and training.
• Preferred Experience coordinating different types of clinical trials.
• Phlebotomy and triage skills are highly desired.
• Must have intermediate knowledge of FDA and ICH/GCP guidelines.
• Experienced in IRB processes, federal research regulations and a basic understanding of funding programs and human subjects research practices.
• Clinical Research Certification (e.g., CCRC or CCRP) is highly desired.
• Proficient in the use of electronic medical records and with medical terminology.
• Proficient with Microsoft applications and databases including Outlook, Teams, Word, and Excel.
• Excellent interpersonal and customer service skills are required.
• Required Knowledge and understanding of GCP guidelines and regulatory requirements to maintain patient safety, confidentiality, and the integrity of the clinical trial process.
• Required Knowledge of the principles of research design.
• Required Ability to write, edit and review protocols and informed consent. Demonstrated organization and time management/prioritization skills with the ability to work independently with minimal supervision as well as perform and follow up with multiple projects.
• Must possess excellent written and oral communication skills, maintain confidentiality of information, demonstrate good decision-making and judgment, and have attention to detail and follow-through skills.
• Ability to function well in a high-paced and at times stressful environment.
• Comfortable with simultaneously managing a variety of technologies across various platforms.
• The incumbent must be able to perform this job safely, without endangering the health or safety of themselves or others.

Language Skills:

• Superior command of writing, proofreading, and communicating in the English language.

Mathematical Skills:

• Ability to calculate figures and amounts such as discounts, interest, proportions, percentages, area, etc.
• Ability to apply concepts of business mathematics and statistical analysis.

Reasoning Ability:

• Ability to deal with problems involving multiple variables in non-standard situations.

Physical Demands:

• An employee must meet the physical demands described here to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
• While performing the duties of this job, the employee is frequently required to sit, use hands, and talk or hear. The employee is occasionally required to stand and walk.
• The employee must occasionally lift and move up to 10 pounds.
• Specific vision abilities required by this job include close vision, color vision, and the ability to adjust focus.

Work Environmen t:

• The work environment characteristics described here represent those an employee encounters while performing the essential functions of this job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
• While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, such as the case of using a paper shredder, copier, or other standard office equipment that contains said portions. The noise level in the work environment is usually moderate.

Conditions of Employment:

• Authorized to work in the USA.
• GLAVREF is an Equal Opportunity/Affirmative Action employer.
• All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.

About GLAVREF:

Our Veterans have given a selfless gift through their service to our country, and they deserve the best health opportunities available. For more than 90 years, the Department of Veterans Affairs (VA) Veterans Health Administration (VHA) has managed or sponsored research and education programs that have led to healthcare breakthroughs and improved the lives of Veterans and the public. The Greater Los Angeles Veterans Research and Education Foundation (GLAVREF) is an independent, non-profit 501(c)(3) designed to support those efforts with one mission in mind: Building partnerships to advance research and education for the health of our Nation's Veterans.

GLAVREF administers VA-approved research and education (primarily in the areas of industry-supported clinical trials and federal grants), and we are looking for a qualified candidate to join us as a Human Resources Generalist.

Our main office is located on the West Los Angeles Veterans Healthcare campus, and this is a full-time salaried position with generous benefits, including medical, dental, vision, vacation, sick leave, and a 403(b) plan. GLAVREF does not sponsor visas.