Clinical Research Coordinator

Clinical Research Coordinator

The clinical research coordinator is responsible for the organization and management of multiple industry sponsored and investigator initiated clinical trials. The position is accountable for assisting in the timely and accurate conduct of research studies, being concerned primarily for the protection and care of the patient as a research patient from initiation to completion of study. Activities include participating in the study start up and termination procedures, working with study participants in various study tasks including patient recruitment, screening for eligibility, scheduling, physical assessments and biospecimen collection and processing, as well as data collection and study completion activities. The research coordinator serves as the liaison between PI and research site and the study sponsor and other vendors working on the trial.

Essential duties and responsibilities include:

• Mission, core values and service excellence: Contributes to the creation of a compassionate and caring environment for patients, families and colleagues through displays of kindness and active listening. Recognizes and appreciates that each employee's work is valuable and contributes to the success of the mission. Demonstrates excellence in daily work. Actively participates in performance and quality improvement activities and works toward enhancing customer/patient satisfaction. Exhibits positive service excellence skills to patients, visitors and coworkers by greeting others in a friendly manner, keeping customers/patients/colleagues informed about progress, delays and changes. Demonstrates effective teamwork by interacting in a positive manner with colleagues and creating a collaborative work environment. Initiates open communication, conveys positive intent, offers assistance. Contributes to a safe and secure environment for patients, visitors, colleagues by following established procedures and protocols, which address the needs of a diverse patient population and workforce. Demonstrates respect for individual differences of each person by acknowledging the essence of each person, appreciating and responding to unique, spiritual, personal and cultural backgrounds of patients, families and colleagues.
• Pre-study initiation: Attend site pre-study visit/qualification visit meetings and site initiation meeting, whether on site or remote. Attend investigator meeting either remote or at location specified by the study sponsor (requires travel). Complete and submit new protocol feasibility questionnaires with research site information. Review confidentiality forms in conjunction with the ORA and obtain appropriate signatures. Assist in study feasibility assessments by considering the patient population, time and personnel requirements, competing trials, ability to maintain patient safety and confidentiality, fiscal soundness, and logistical capabilities including interdepartmental needs, i.e. radiology, operating room, inpatient and outpatient pharmacy. Prepare and submit pre-IRB approval documents for review and approval by the following institutional committees as appropriate: Research Pharmacy, Value Analysis (VAMS), Antibiotic Sub-committee, Radiation Safety Committee, Institutional Biosafety Committee, Departmental Review Committees. Prepare and submit regulatory documents required by federal regulations to the Study sponsor/CRO prior to site initiation and maintain during the course of the study 1572 (pharmaceutical trials) Statement of investigator (device trials) Financial Disclosure forms for PI and Sub Investigators (SI) CV and medical license for PI and Sub Investigators (SI) Current Human Subject Protection and Good Clinical Practice (GCP) training certificates for all personnel on the study IATA training certificates (if applicable for the study) Complete the delegation of authority/duty logs to indicate the site personnel involved with the study and update as necessary throughout the course of the study with either new study personnel or personnel that is no longer involved with the study. Prepare the patient informed consent (ICF) and assent (if applicable) by inserting the AMC required language into the sponsors ICF template and submitting to the sponsor for approval prior to IRB submission prior to IRB submission Prepare for study site initiation visit Schedule visit and all required personnel (PI, sub-investigators, coordinators, research manager, pharmacy, clinical nursing units, operating room staff, etc.) to be present Schedule study specific training visits, Ensure all study required items are on-site (tablets for questionnaires, lab supplies, devices, study medication/investigational products, EKG machine, etc.)
• Develop original source data collection worksheets to comply with protocol specific data requirements to include adverse event logs, and medication logs to ensure all required patient data is collected.
• IRB: Prepare initial IRB submission documents to include: AMC Checklist, IRB application, study protocol, ICF, advertisements, Investigator Brochure, patient diaries (paper or screen shots), patient questionnaires, other patient facing materials Submit the new protocol IRB submission to the ORA through the InfoEd portal and after approval submit to the either WCG through Connexus Portal or approved IRB of record. Prepare and submit annual continuing review reports and site termination report to the IRB of record Prepare and submit any changes to the IRB approved study documents as requested by the study sponsor to include protocol amendments, changes to the ICF, new versions of the Investigator Brochure, new or changes to advertisements of patient facing materials Prepare and submit protocol deviations and/or violations to the study sponsor and IRB as necessary
• Patient interactions: Participate in or conduct the informed consent process and HIPAA authorization, per AMC SOP, with research participants through discussion of the study protocol, procedures, timelines, risks, benefits and answering any questions. Obtain the appropriate signatures and dates/time on the ICF form and documents the process and file a copy in the patient's medical record. Assures that patients sign any future amended versions of the consent if applicable. Develop study schedule and required procedures, timelines, and deadlines with study patient and family, the PI and research team. Coordinate patient follow-up study visits, treatments, testing, procedures, and schedules Conduct patient study visits and required assessments per each individual protocol Assess patients for eligibility using the study specific inclusion and exclusion criteria. Perform patient health assessments to include but not limited to: Vital signs, EKG, medication and medical history review as required per protocol and as ordered by the PI/Sub-I, Obtain required biological specimens from patient, i.e., urine, sputum, etc. Perform blood draw to obtain blood specimens Administer study specific scales; i.e. stroke scales, mental assessments, etc. Administer questionnaires to be completed by the patient, i.e. quality of life questionnaires, pain scores, etc., and review for completeness Perform POC testing as applicable per SOP, i.e. urine pregnancy, urine drug test, blood sugar, urinalysis Coordinate/schedule other study required procedures to be done, i.e. physical exam with study provider, radiology, ultrasounds, echocardiograms, follow up study visits etc. Dispense to patient and train patient on completion of study diary, if applicable Review completed patient diaries with patient In conjunction with the provider, provide oral study mediation to the patient or set up/schedule medication infusions or coordinate with nurse to administer study medication injection. Review oral study medication compliance with patient at each visit Collect required data from the patient Procedure Visit Clinic procedure room, Operating room, Cath lab, Angio suite, etc.
• Ensure appropriate study medication or device is ordered for procedure
• Ensure appropriate study personnel are scheduled and present for procedure
• Transport study medication or device to appropriate location
• Review intra operative inclusion/exclusion criteria
• Randomize patient to treatment arm, if required
• Collect required data before, during and after the procedure
• Ensure study procedure requirements are followed
• Collect specimens as appropriate and send to sponsor as required
• Monitor and communicate on a continuous basis with patients and families to facilitate identification of untoward side effects/adverse events and initiate and coordinate clinical care to manage and minimize harm to research patient
• Financial: Assist with budget preparation and negotiation Assist with the submission of the contract agreement draft to the ORA for review and approval Assist with obtaining the appropriate signatures on the final Clinical Trial Agreement (CTA) Assist in the preparation and submission of forms to establish a new research cost center Complete departmental signature form, compliance checklist, patient budget form Obtain signatures of PI and Department Chair Submit to ORA finance with the final CTA and budget Assist with Completion of signature card with signatures of PI, Practice manager, department chair (as appropriate) Prepare and submit electronic form to establish research insurance billing account Ensure study patient visits for coordinator and providers are scheduled using the research insurance for billing to the appropriate study Complete Research Grant Registration form to ensure proper billing and submit to appropriate department when scheduling research test/procedure that will be billed to the research grant Complete and submit the Research Encounter form following study office visits for proper billing to the research grant Assist with preparation of invoices to the sponsor for payments per the contract and budget Assist with payment of AMCH/PBS and AMC Faculty Practice/MCPG research services Review in-patient bills and prepare Research Grant Registration form for inpatient research charges and submit to appropriate department to ensure proper billing of research services per contract/ budget Submit patient stipend /travel reimbursement payment information to ORA finance to be set up in Greenphire Pay patient stipends through Greenphire after completion of patient visits per contract/budget and ICF Maintain Greenphire card accountability log and keep cards in a secure location Assist in maintaining log of patient visits, stipends, and invoices.
• General: Communicate and interact with PI and research team, study sponsors, IRB (AMC IRB, WCG IRB, CIRB, other IRB of record), Office of Research Administration (ORA), appropriate AMC departments (compliance, finance, faculty practice, pharmacy, radiology, laboratory medicine, pathology etc.) and Operating Room, Cath lab, and in-patient units, etc. Communicate and interact with NIH/NC