Overview
Job Title: Clinical Research Coordinator 3
Job Location: Troy, NY, 12180
Duration: 6+ months with possible extension and conversion in FTE
Shift: Part time hours are flexible based on the employee’s schedule, i.e., any 24 hours of the week, 3 days per week (8 hour days)
Job Description
Perform a variety of clinical procedures to collect, record, report and interpret data on patients enrolled and/or seeking enrolment in clinical studies according to the protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP).
Assist with daily workload planning.
Responsibilities
- Provide clinical research support to investigators to prepare for and execute assigned research studies, including:
- 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 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.
- 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.
Required Knowledge, Skills, and Abilities
- 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
Minimum Required Education and Experience
- High school diploma (a BS would be a plus) 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