Clinical Research Coordinator

U.S. Urology Partners • Voorhees, NJ

18d • $17 - $22 • Onsite

About The Position

About the Role The Clinical Research Coord inator (CRC) is responsible for conducting and documenting clinical research and trials for the Research Division while adhering to Good Clinical Practice/ICH Guidelines and the Code of Federal Regulations. What You’ll Be Doing Administratively and clinically coordinates a team to effectively conduct a minimum six clinical trials (level 1- 3 clinical research protocol) and evaluates/analyzes clinical data and trial results . Schedule, plan and participate in study monitoring visits and addresses any potential queries or deviations in accordance to the study contract . A cts as a liaison between sponsor and the research department . In collaboration with the Clinical Manager advise s treating physicians of clinical protocol opportunities and procedures . Recruitment of study subjects, including use of professional experience, discretion and judgment to include or exclude potential subjects based on trial criteria . Acts as a study resource for patients and family. Discuss es study protocols with patients and ve rifies the informed consent process and documentation. Addresses any questions or concerns the research patient may have regarding the study. Provides patient with written communication of their participation. Ensure s subject s understanding and willingness to continue participation as well as conduct study specific procedures and assessments (within his/her scope of practice) at each visit. This includes providing patients all treatment option information within their scope of practice such as pamphlets and protocol direction. D ispenses study medications in accordance to protocol requirements w ithin his/her scope of practice. Performs Investigational Product accountability for accurate compliance. Collect s , process es and ship s blood/urine specimens at scheduled times. S upervisors scheduling of research patient visits and procedures consistent with pr otocol requirements. Performs study specific procedures, including but not limited to E C G’s, v ital s igns, height, weight, injections etc. within his/her scope of practice. Collect, compile and maintain source documentation. Complete s and maintain s case report forms per FDA guidelines while ensuring source completeness and accuracy. Prepare s and participate s in quality assurance audits by study sponsors, federal agencies, or specially designated review groups. R esponsib le for the reporting of and follow up on adverse events and serious adverse events per study protocol. Screens all laboratory and radiographic results following protocol proced ures regarding abnormal results assuring that all results are re viewed by a physician, PI or SI for clinical significance. Contact s outside health care providers and communicate s with subjects to obtain follow up information . Ensure s scientific integrity of data and protect s the rights, safety, and well-being of patients enrolled in clinical trials. Ensure s filing and maintenance of all regulatory documents . Attends sponsor meetings for the purpose of education and understanding of protocols or protocol addendums. Maintains required continuing education hours required for certifications. Adherence and knowledge of OSHA including the location and use of Material Data Safety Sheets (MSDS). Maintains a high level of patient confidentiality. Performs all other duties as assigned.

Requirements

• Associates or Bachelor’s Degree from an accredited college or university
• Good Clinical Practice (GCP) Certificate
• International Air Transport Association (IATA) Certificate
• CCRC certification through an accredited organization (ACRP/ SoCRA ) is required
• 2-3 years related Research experience
• Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
• Computer Skills To perform this job successfully, an individual should have thorough knowledge in computer information systems

Nice To Haves

• Preferred

Responsibilities

• Administratively and clinically coordinates a team to effectively conduct a minimum six clinical trials (level 1- 3 clinical research protocol) and evaluates/analyzes clinical data and trial results
• Schedule, plan and participate in study monitoring visits and addresses any potential queries or deviations in accordance to the study contract
• Acts as a liaison between sponsor and the research department
• In collaboration with the Clinical Manager advise s treating physicians of clinical protocol opportunities and procedures
• Recruitment of study subjects, including use of professional experience, discretion and judgment to include or exclude potential subjects based on trial criteria
• Acts as a study resource for patients and family
• Discuss es study protocols with patients and ve rifies the informed consent process and documentation
• Addresses any questions or concerns the research patient may have regarding the study
• Provides patient with written communication of their participation
• Ensure s subject s understanding and willingness to continue participation as well as conduct study specific procedures and assessments (within his/her scope of practice) at each visit
• This includes providing patients all treatment option information within their scope of practice such as pamphlets and protocol direction
• D ispenses study medications in accordance to protocol requirements w ithin his/her scope of practice
• Performs Investigational Product accountability for accurate compliance
• Collect s , process es and ship s blood/urine specimens at scheduled times
• S upervisors scheduling of research patient visits and procedures consistent with pr otocol requirements
• Performs study specific procedures, including but not limited to E C G’s, v ital s igns, height, weight, injections etc. within his/her scope of practice
• Collect, compile and maintain source documentation
• Complete s and maintain s case report forms per FDA guidelines while ensuring source completeness and accuracy
• Prepare s and participate s in quality assurance audits by study sponsors, federal agencies, or specially designated review groups
• R esponsib le for the reporting of and follow up on adverse events and serious adverse events per study protocol
• Screens all laboratory and radiographic results following protocol proced ures regarding abnormal results assuring that all results are re viewed by a physician, PI or SI for clinical significance
• Contact s outside health care providers and communicate s with subjects to obtain follow up information
• Ensure s scientific integrity of data and protect s the rights, safety, and well-being of patients enrolled in clinical trials
• Ensure s filing and maintenance of all regulatory documents
• Attends sponsor meetings for the purpose of education and understanding of protocols or protocol addendums
• Maintains required continuing education hours required for certifications
• Adherence and knowledge of OSHA including the location and use of Material Data Safety Sheets (MSDS)
• Maintains a high level of patient confidentiality
• Performs all other duties as assigned

Benefits

• competitive compensation
• well-rounded benefits package includes a range of comprehensive medical, dental and vision plans
• HSA / FSA
• 401(k) matching
• Employee Assistance Program (EAP)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree
• Number of Employees: 501-1,000 employees