Clinical Research Coordinator - Dubois, PA

Are you looking for your next opportunity in Clinical Research?  Do you want to work for an industry leading company that offers you an excellent benefits package and supports career progression?  If so, come and join us!

We are looking for experienced candidates to perform a variety of clinical procedures to collect, record, report and interpret data on patients enrolled and seeking enrollment in clinical studies according to the protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP). This role will be supporting on-site the clinical research site in Dubois, PA, for 30h/week.
 

Day to day responsibilities will include:

• Providing 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 relevant 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
• 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
• 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.

We are looking for candidates with the following skills and experience:

• BS/BA in life sciences or educational equivalent and/or relevant work experience in a clinical environment or medical setting
• Knowledge of medical terminology
• Knowledge of clinical trials, combined with in-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules
• Strong IT competence, skilled in using MS Windows and Office applications such as Access, Outlook, Excel, and Word
• Must have previous experience of EDC entry and query resolution
• Ability to pay close attention to detail
• Excellent interpersonal skills with the ability to establish and maintain effective working relationships with co-workers, managers and clients
• Good organizational skills with the ability to pay close attention to detail