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Planet Pharma · 6 hours ago

Clinical Research Coordinator 3

Charleston, SC

Full-time

Onsite

Mid Level

$25/hr - $38/hr

Planet Pharma is seeking a Clinical Research Coordinator 3 to perform a variety of clinical procedures and support investigators in executing research studies. The role involves recruiting and screening patients, maintaining study documentation, and ensuring compliance with regulatory requirements.

BiotechnologyHealth CarePharmaceutical

Responsibilities

Perform clinical research support to investigators to prepare for and execute assigned research studies

Review study protocols, Case Report Forms (CRFs), other study-specific documents, and electronic data capture systems used to record clinical research data

Attend all relevant study meetings

Collect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical research

Recruit and screen patients for clinical trials and maintain subject screening logs

Orient research subjects to the study, including the purpose of the study, procedures, and protocol issues such as timelines for visits

Design and maintain source documentation based on protocol requirements

Schedule and execute study visits and perform study procedures

Collect, record, and maintain research subject study data according to study protocol and SOPs, preserving quality control for content, accuracy, and completeness

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

Monitor subject safety and report adverse reactions to appropriate medical personnel

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

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 complex clinical research procedures including ECG, sample collection, spirometry, vital signs, dose verification, cannulation, and cardiac telemetry monitoring

Record, report, and interpret study findings appropriately to develop a study-specific database

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 projects

Qualification

Clinical trialsMedical terminologyMS WindowsOffice proficiencyAttention to detailInterpersonal skills

Required

Knowledge of clinical trials

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

Knowledge of medical terminology

Skilled in using MS Windows and Office applications such as Access, Outlook, Excel, and Word

Excellent interpersonal skills

Ability to pay close attention to detail

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

High school diploma or educational equivalent and relevant work experience in a clinical environment or medical setting; or equivalent combination of education, training, and experience

Applicable certifications and licenses as required by the company, country, state, and/or other regulatory bodies