Job Description

Job Description

Job Description

The Clinical Research Coordinator (CRC) plans, coordinates, and manages the 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.

 

Primary Duties and Responsibilities

• Works collaboratively with Principal Investigator and clinical staff to identify eligible participants for clinical trials.
• When required, administer and document informed consent prior to initiation of any study related activities.
• Educates affected hospital personnel to the details of the trial(s).
• Educates patients and their families to assure that they are informed prior to obtaining written consent.
• Responsible for follow-up and active patient monitoring per study protocol.
• Collects, maintains, and stores all relevant clinical data and case report forms, in accordance with the study sponsor and all regulatory bodies.
• Maintain accurate records of subject drug accountability and assist Investigational Drug Service (IDS) with the receipt, inventory, and dispensation of study drug and materials as necessary. Work with the clinical staff to administer study drug to research subjects when applicable.
• Collect/obtain, process and ship subject blood, cultures, tissues, and other specimens for laboratory analysis as described in study protocol(s).
• Collect pertinent information and data from subject charts and records, subject interviews, and other sources, while maintaining the highest standards in protection of VA sensitive information. Create and complete case report forms (CRFs) in accordance with research protocol guidelines.
• Inspect CRFs, source documentation, and study files to ensure completeness.
• Review CRFs, source documentation, and study files with representative from 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.
• Comply with standard operating procedures of the sponsor, institutional review board (IRB), and CRO involved with the trial.
• Compile and submit reports, documents, and correspondence as necessary to the IRB, sponsor, and CRO.
• Present information and respond to questions from physicians, staff, and patients.
• Report any evidence of research non-compliance in a timely fashion.
• Comply with VA Research Office and Medical Center education requirements.
• Provides cross coverage for trials as assigned.
• Update the Clinical Trials Management system in a timely manner, which includes but is not limited to subject enrollment, patient payments and entering 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 or CTC Manager.
• Minimal travel required, CRC will attend management approved educational conferences and study meetings when available.
• Routinely check all study lab kits for expiration. Ensure new kits are ordered as needed and expired kits are disposed of and documented as directed.
• Schedule equipment calibrations when needed and maintain chemical inventory for CTC studies.
• Assist with routine safety checks for the phlebotomy room.
• Assist CTC manager in ordering and managing office supplies.
• Other duties as assigned.

 

Qualifications

• Associate degree AND a minimum of two years’ experience in a clinical research setting, OR an equivalent combination of education, experience, and training.
• Phlebotomy skills required.
• Experience in obtaining vitals preferred.
• 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) highly desired.
• Proficient in use of electronic medical records and with medical terminology
• Proficient with Microsoft Office Suite or related software
• Excellent interpersonal and customer service skills required.
• 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.

Company Description

VHF is a mission driven organization that values a team-oriented culture and actively encourages internal career advancement. We are a mid-size nonprofit, closely connected with the VA and its affiliated academic medical partners. We are a nimble organization, offering ongoing training, opportunities for growth, generous benefits, great work-life balance, as well as friendly, close-knit, and supportive environment. At VHF, we work with more than 160 uniquely talented medical scientists across a broad spectrum of research areas. We recruit talented employees who believe in making a difference in the lives of others through innovative research.

VHF is delighted to offer a competitive employee benefits package which includes:
• 19 days Paid Time Off
• 11 Paid Federal Holidays
• a 401(k) with a 5% company match
• Medical, Vision, & Dental insurance for Employees and Families- Employer paid at 70%
• Professional development training

Company Description

VHF is a mission driven organization that values a team-oriented culture and actively encourages internal career advancement. We are a mid-size nonprofit, closely connected with the VA and its affiliated academic medical partners. We are a nimble organization, offering ongoing training, opportunities for growth, generous benefits, great work-life balance, as well as friendly, close-knit, and supportive environment. At VHF, we work with more than 160 uniquely talented medical scientists across a broad spectrum of research areas. We recruit talented employees who believe in making a difference in the lives of others through innovative research.\r\n\r\nVHF is delighted to offer a competitive employee benefits package which includes:\r\n• 19 days Paid Time Off\r\n• 11 Paid Federal Holidays\r\n• a 401(k) with a 5% company match\r\n• Medical, Vision, & Dental insurance for Employees and Families- Employer paid at 70%\r\n• Professional development training

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