AlbanyGARecruiter Since 2001
the smart solution for Albany jobs

Clinical Research Coordinator

Company: Javara
Location: Albany
Posted on: March 19, 2020

Job Description:

Job Description For: CLINICAL TRIAL NAVIGATOR Location:
Albany, GA
Summary/Objective: This position is responsible for managing the conduct of assigned clinical trial activities. This position reports directly to the Director/Associate Director of Clinical Trial Operations. Essential Responsibilities: Promoting the mission of Javara with a primary guiding principle of research participant safety, research participant well-being, and doing so with integrity and excellence to those we serve. The Clinical Trial Navigator (CTN) is a specialized research professional, responsible for the coordination and administration of clinical trials under the direction of the Director/Associate Director of Clinical Research and the Principal Investigator or designee. The CTN implements and coordinates research study procedures for the successful management of clinical trials. The CTN position requires someone who is knowledgeable of study specific protocols as well as regulations and guidance for the conduct of clinical trials. Specific Responsibilities:


  • Manage clinical research studies and adhere to Javara Standard Operating Procedures (SOPs), our healthcare partner's SOPs, Good Clinical Practices (GCPs), study protocols, clinical trial agreements, and regulations governing clinical research.


    • Ensure scientific integrity of data and protect the rights, safety and well-being of research participants.


      • Navigate the resources and workflow within the healthcare and clinical research environment to ensure seamless care for the clinical trial participant, to engage investigators in research daily and to promote clinical research within the healthcare system.


        • Create and implement a patient engagement plan to identify and contact potential research participants, and then screen and enroll participants in suitable clinical research studies.


          • Conduct and document the informed consent process when delegated to do so by the Principal Investigator in compliance with Javara's SOPs.


            • Demonstrate competency with respect to both clinical trial conduct and specific research studies with investigators, healthcare partners, sponsor, CRO, research team, and potential and active research participants.


              • Coordinate research participant visits and study related procedures according to study protocol windows and study team schedules. This may involve handling travel logistics for research participants.


                • Ensure reminder communications (phone, text or email as requested by the participant) are conducted to promote show rate and compliance.


                  • Conduct clinical research study visits/procedures per protocol requirements. This may require obtaining vital signs, height, weight, EKG's, spirometry, medical history, medications, adverse events and labs as well as administering questionnaires and diaries.


                    • Collect, process and ship any bodily samples such as blood and urine as required per protocol in compliance with Javara's SOPs and laboratory guidelines.


                      • Dispense investigational product and other research study supplies in an accountable manner in accordance with study requirements, institutional requirements, investigator approval and regulations.


                        • Inform and educate the research team and healthcare system staff regarding study related procedures including IP dosing and monitoring requirements.


                          • Assist with Integrating clinical research as a care option within the healthcare system.


                            • Monitor and report adverse events, serious adverse events and protocol deviations to the investigator, sponsor and IRB in compliance with Javara's SOPs.


                              • Know and understand regulatory requirements, maintain files and documents, and assist the Regulatory Navigator/Manager of Trial Activation with regulatory submissions.


                                • Create source documents and document appropriately in source documents and /or medical records (paper, EMR, e-source) per ALCOA: data is attributable, legible, contemporaneous, original and accurate.


                                  • Complete and maintain case report forms (paper or electronic) and answer queries regarding study data per FDA regulations, clinical trial agreement and protocol requirements.


                                    • Prepare and participate in routine monitoring visits, internal and external audits, and inspections.


                                      • Ensure study documentation is audit ready in the event of monitoring, audits and inspections.


                                        • Assist with additional projects as requested by Director/ Associate Director of Clinical Research Operations.

                                          Work Environment: This job operates in a professional environment. This role routinely uses standard office equipment such as computers, laptops, tablets, phones, photocopiers, and printers. Position Type: This is a full-time, exempt position. Travel: This position may involve travel between research centers, medical practices, and the Javara main office. This position may involve traveling to meetings and some of the meetings may require air travel. Travel within the USA or to other countries for 2-3-day trips may be required at least 6 times per calendar year. Education or Equivalent Experience:

                                          • Bachelor's degree preferred or equivalent experience.


                                            • Work experience in a related field preferred.


                                              • Able to use standard office software, as well as proprietary applications unique to the clinical trial industry.


                                                • Must present a pleasant, professional, and helpful demeanor

                                                  Qualifications:

                                                  • Exceptional planning and organizational skills.


                                                    • Highly motivated to provide exceptional service.


                                                      • Able to work autonomously or as part of a team.


                                                        • Able to manage challenging situations and conflicts and resolve problems effectively.


                                                          • Excellent interpersonal skills with proven written, presentation and verbal competencies.


                                                            • Able to multi-task and manage multiple priorities while demonstrating excellent customer service behavior

                                                              Refer to ACRP Core Competency Guidelines for CRC's: www.acrpnet.org/core-competency-guidelines-clinical-research-coordinators-crcs/ Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. About Javara: Javara is an integrated research organization (IRO) that advances value by integrating clinical research within the healthcare ecosystem. Javara brings better outcomes for patient centered care, better economic results, improved access to cutting edge therapies and a more predictable research delivery model to the biopharmaceutical sector. EOE Statement: Javara is an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.

Keywords: Javara, Albany , Clinical Research Coordinator, Healthcare , Albany, Georgia

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Healthcare Jobs


Advanced Practice Registered Nurse Job-PT
Description: There is an open Per Diem Nurse Practitioner NP Home Health Flexible Schedule job in Leon County, FL. The Per Diem Nurse Practitioner NP will conduct home health risk assessments within Leon County, (more...)
Company: Sunbelt Staffing
Location: Tallahassee
Posted on: 04/10/2020

IR RN-Interventional Radiology
Description: IR RN-Interventional Radiology br br 12 HR Shift 10 HRS are possible if needed br br
Company: Sunbelt Staffing
Location: Tallahassee
Posted on: 04/10/2020

Tallahassee Stepdown RN Needed
Description: We have need for an experienced Stepdown RN to assist patients that have recently been moved from an ICU setting. A hospital in the
Company: Sunbelt Staffing
Location: Tallahassee
Posted on: 04/10/2020


RN / Registered Nurse / Georgia / Any / ICU RN Job
Description: Critical Care NurseMacon, GASeeking an energetic ICU RN to come join our team today. We have exciting, Great Paying opportunities across the U.S. ul li Both Local and Travel candidates are welcome (more...)
Company: HumanEdge
Location: Macon
Posted on: 04/10/2020

Travel Nurse (RN) PICU (Pediatric Intensive Care Unit)
Description: This is a travel Nurse - PICU assignment in Tallahassee, FL, working nights. Don't miss this exciting Pediatric Intensive Care Unit
Company: Emerald Health Services
Location: Tallahassee
Posted on: 04/10/2020

Psychiatrist (child)
Description: Psychiatric-Mental Health opening in Tallahassee, Florida. This and other physician jobs brought to you by DocCafe.com br
Company: Spot On Recruiting, Inc.
Location: Tallahassee
Posted on: 04/10/2020

Critical Care Physicians need in Florida
Description: Critical Care/Trauma opening in Tallahassee, Florida. This and other physician jobs brought to
Company: Jackson & Coker
Location: Tallahassee
Posted on: 04/10/2020

Child Psychiatry Physician in Tallahassee, Florida
Description: Psychiatry-Child/Adolescent opening in Tallahassee, Florida. This and other physician
Company: Integrity Healthcare
Location: Tallahassee
Posted on: 04/10/2020

Travel RN-Telemetry
Description: ul br li We are seeking an experienced and self motivated telemetry registered nurse to join our growing team of nursing professionals
Company: RNnetwork
Location: Columbus
Posted on: 04/10/2020

Medical Surgical Nurse - Travel - (MS RN)
Description: Job Description Requirements br br Medical Surgical Nurse - MS RN br br StartDate: ASAP Available Shifts: 12 N Pay Rate: 1141.00 - 1259.00 br br br ul br li MedSurg RNs needed (more...)
Company: American Mobile Healthcare
Location: Tallahassee
Posted on: 04/10/2020

Log In or Create An Account

Get the latest Georgia jobs by following @recnetGA on Twitter!

Albany RSS job feeds