Clinical Research Coordinator

1 month ago

Statesville, United States UpTrials Full time

Description

JOB SUMMARY

A Clinical Research Coordinator (CRC) is responsible for reviewing, processing, and managing clinical research data and

documents, both regulatory and patient records. The CRC performs a variety of clinical procedures, and assists with daily

workload planning; ie; collect, record, report, and interpret data on patients enrolled in and/or seeking enrollment in clinical

studies according to the protocol, SOPs, and GCPs.

RESPONSIBILITIES

• Provide clinical research support to investigators to prepare for and execute assigned research studies, including:

o Collect, record, and maintain research subject study data according to study protocols and SOPs, preserving

quality control for content, accuracy, and completeness.

o Collect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies

governing the conduct of clinical research.

o Recruit and screen participants for clinical trials and maintain subject screening logs.

o Assist in the initial and ongoing consent process; orient research subjects to the study, including the purpose

of the study, procedures, and research process.

o Maintain source documentation based on protocol requirements.

o Schedule and execute study visits and perform study procedures.

o Handle lab testing and analysis, including preparation of specimen collection tubes, shipment, and lab

logistics.

o Monitor subject safety and report adverse events/reactions to the Principal Investigator and/or appropriate

medical personnel.

o Correspond with research subjects and troubleshoot study-related questions or issues.

o Participate in “huddles” to confirm daily study tasks are assigned to team members and are executed to the

expected standards.


• Assist with study data quality checking and query resolution.

• Perform a variety of complex clinical research procedures including but not limited to ECG, sample collection,

spirometry, vital signs, dose verification, cannulation, and cardiac telemetry monitoring, if needed.

• Assist investigator in verifying that research study objectives are met on time, within budget and according to

applicable protocol requirements, clinical research regulations and quality standards.

• Provide training to new investigator site staff members on study-specific topics and requirements. Assist in

maintaining adherence to investigator site staff training requirements by auditing and maintaining training records.


• Prepare for and attend study monitoring visits, study audits, and regulatory inspections with clinical research

regulatory agencies.

• Assist research site with coverage planning related to staffing and scheduling for research studies.

• Monitor subject safety and report adverse reactions to appropriate medical personnel.

• Maintain confidentiality of data and PHI as required.

• Collaborate with provider offices to carry out research in the most efficient workflow possible.

• Maintains stock of supplies needed to carry out each study per protocol.

• Performs other duties and projects as assigned.

QUALIFICATIONS

• Bachelor's degree in a related field

• 1-2 years of clinical research experience

• Relevant work experience in a clinical environment or medical setting, e.g., medical assistant, assistant nurse,

laboratory technician; or equivalent combination of education, training, and experience

• Proficient in the use of Microsoft Office applications

• Understanding of medical terminology

• Working knowledge of clinical trials

• Knowledge and ability to apply GCP/ICH and all applicable FDA regulations and guidelines for human subject

protection, drug, and device.

• In-depth knowledge of departmental, protocol, and study-specific operating procedures, consent forms, and study

schedules

• Skilled in carrying out required clinical procedures such as phlebotomy and vital signs.

• Strong written and verbal communication skills including good command of the English language.

• Skill in applying and modifying professional research principles, methods, and techniques to provide ongoing patient

care.

• Skill in preparing/maintaining records, writing reports, and responding to correspondence.

• Ability to maintain quality control standards.

• Ability to react calmly and effectively in all situations.

• Excellent organizational and problem-solving skills.

• Effective time management skills with the ability to multi-task and manage competing priorities with exceptional

attention to detail.

• Ability to establish and maintain effective working relationships with physicians, coworkers, managers, and clients.

• Practice a high level of integrity, honesty, and in maintaining confidentiality.

BENEFITS

• Competitive salary

• Health Insurance

• Dental Insurance

• Disability Insurance

• Life Insurance


• Paid Time Off

• Vision Insurance

WORKING CONDITIONS

Due to the nature of this position, employees are expected to work in person. This is an exempt position under the federal and

state wage and hour laws, which means you are not eligible for overtime pay beyond your salary. Employees are expected to

work 40 hours a week. Occasional evening and weekend work may be required as job duties demand.

Applicants must be authorized to work for ANY employer in the U.S. We are

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