Clinical Research Coordinator — Study Start-Up & Compliance

Green Key Resources; Town of Florida (NY); On-site; USD 55,000 - 75,000; Full time

Job summary

Green Key Resources seeks a Clinical Research Coordinator (CRC) to ensure compliant execution of assigned studies under GCP, ICH, HIPAA and FDA regulations. The role involves screening patients, collecting data, vital signs, ECGs and coordinating lab procedures and shipments.

You will maintain sourcelogs, assist with study start-up, monitor visits, and report adverse events within timelines. Strong organizational, communication and confidentiality skills are essential.

Qualifications

• A Medical Assistant diploma, LPN/LVN, EMT credential OR Associate’s degree AND a minimum of 1 year of clinical research or clinical experience, OR an equivalent combination of education and experience, is required.
• Proficiency with performing basic clinical procedures such as (blood pressure, vitals, EKGs, phlebotomy, etc.) is highly preferred.
• Bi-lingual (English / Spanish) proficiency is a plus.

Responsibilities

• Screening of patients for study enrollment.
• Documenting in source clinic charts.
• Entering data in EDC and answers queries.
• Obtaining vital signs and ECGs.
• May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up.
• Requesting and tracking medical record requests.
• Updating and maintaining logs, chart filings.
• Maintaining & ordering study specific supplies;]
• Scheduling subjects for study visits and conducts appointment reminders.
• Building/updating source as needed.
• Conducting monitoring visits and resolves issues as needed in a timely manner.
• Ensuring study related reports and patient results are reviewed by investigator in a timely manner.
• Filing SAE/Deviation reports to Sponsor and IRB as needed.
• Documenting and reporting adverse events;
• Reporting non-compliance to appropriate staff in timely manner.
• Maintaining positive and effective communication with clients and team members.
• Always practicing ALCOAC principles with all documentation.
• May assist with study recruitment, patient enrollment, and tracking as needed.
• Maintaining confidentiality of patients, customers and company information, and;
• Performing all other duties as requested or assigned.
• Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc.;
• Prepare and attend site initiation visits (SIV’s) and Investigator Meetings (IMs), as needed;
• May set up, train and maintain all technology needed for studies.

Skills

Microsoft Office

Typing 40 wpm

Clinical procedures

Organizational skills

Communication skills

Multitasking

HIPAA compliance

Education

Medical Assistant diploma

LPN/LVN

EMT credential

Associate’s degree

Tools

Electronic Health Records

Job description

Green Key Resources seeks a Clinical Research Coordinator (CRC) to ensure compliant execution of assigned studies under GCP, ICH, HIPAA and FDA regulations. The role involves screening patients, collecting data, vital signs, ECGs and coordinating lab procedures and shipments.

You will maintain sourcelogs, assist with study start-up, monitor visits, and report adverse events within timelines. Strong organizational, communication and confidentiality skills are essential.