Ctc 2

Job Overview
Perform a variety of clinical procedures to collect, record, report and interpret data on patients enrolled and/or seeking enrollment in clinical studies according to the protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP). Assist with daily workload planning.

Essential Functions
- 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;
- Design and maintain source documentation based on protocol requirements;
- Schedule and execute study visits and perform study procedures;
- Handle lab testing and analysis, including preparation of specimen collection tubes and lab logistics;
- 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.

**Qualifications**:

- Bachelor's Degree Req Or
- High School Diploma or equivalent Req
- 5 years’ 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 X Req
- Working knowledge of clinical trials
- Working knowledge of the principles of Good Clinical Practices (GCP)
- In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules
- Skill in carrying out required clinical procedures such as intravenous catheter insertion and spirometry testing
- Excellent interpersonal skills
- Ability to pay close attention to detail
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies Req