Job Description
Research Coordinator Colorado Heart & Vascular, PC - 3.5 Golden, CO Job Details Full-time $22 - $25 an hour 1 hour ago Benefits Health insurance Dental insurance 401(k) Paid time off Vision insurance Employee discount Life insurance Qualifications Computer operation Clinical research HIPAA Employee relationship building Driver's License Bachelor's degree Document review Data collection
Full Job Description Job Title :
Research Coordinator 1 Department :
Research Supervisor :
Research Manager GENERAL SUMMARY OF DUTIES
Responsible for being primary contact on a sub-set of clinical trials; responsibilities include: interacting with patients to complete clinical trial related requirements. Interacting with sponsors to maintain the study in a state of readiness. Primary point of contact for physicians, patients, CHV staff, sponsors, and IRBs to carry out study related protocol and tasks. Responsible for organizing study related material and executing proper practices within study specific protocols. ESSENTIAL FUNCTIONS
GENERAL SUMMARY OF DUTIES
Responsible for being primary contact on a sub-set of clinical trials; responsibilities include: interacting with patients to complete clinical trial related requirements, Interacting with sponsors to maintain the study in a state of readiness. Primary point of contact for physicians, patients, CHV staff, sponsors, and IRBs to carry out study related protocol and tasks. Responsible for organizing study related material and executing proper practices within study specific protocols. ESSENTIAL FUNCTIONS
Understand the principles of clinical research including informed consent, good clinical practice, and human research protection. Able to explain and train junior staff members and non-research staff on these principles so they can participate in clinical research. Develop strong working relationships and maintain effective communication with study team members, physicians, and study sponsors. Under the direction of the research manager, serve as primary point of contact for sub-set of clinical trials determined by the Research Manager. Work directly with prospective and enrolled subjects and their families or caregivers, as applicable, including reviewing and completing informed consent, case report forms and other electronic media. Screen and recruit potential study participants. Work directly with physicians to discuss potential participants and to review inclusion/exclusion criteria. Review and extract information from electronic medical records and other source documents to complete case report forms and other study related media. Observe and take notes of hospital-based surgeries and procedures to be able to complete study related material. Independently, but with oversite from the research manager, will observe trends in clinical research, identify potential areas of growth, and pursue clinical trials in the identified area including, attending conferences to understand scientific fields of interest of physician investigators, identifying and pursing contacts in the research space who may be beneficial to the investigators of CHV, and bringing clinical trials to the research manager and physicians for potential participation. Without supervision, responsible for overseeing the day-to-day operations of clinical trials and studies. Must be able to explain complex research protocols at a patient's level of comprehension. Must be able to patiently explain studies to patient families often times repeatedly. Able to review legal documents (including CDAs, CTAs, and FUAs) and provide advice to the research manager of changes that are required or items that will not be acceptable. Able to take these documents and create drafts of changes that are acceptable to CHV. Able to work with a variety of databases to complete manual data entry. Able to oversee and train other research coordinators and act as primary point of contact for junior staff. Track key study metrics using tracking tools (creating and maintaining documents, tables, databases, spreadsheets, and files), providing timely and quality updates to research manager and/or CHV Leadership. Under direction of the research manager, must be able to identify the paypoints for a given sub-set of studies, review sponsor provided documentation of payment, identify what procedures, diagnostics or activities remain unpaid and why, and work with sponsor to ensure full payment is received. Create invoices for invoiceable costs and request reimbursement for local IRB oversight/cede. Adhere to IRB approved protocol for both central and local IRBs. Able to submit documentation to IRBs and address most of the IRB's questions with and without supervision. Coordinate protocol related research procedures, study visits, and follow-up care. Coordinate and lead sponsor, CRO, hospital, physician, or IRB meetings. Must be able to attend or run these meetings. Able to report back to the research manager the content and context of the meeting so that the research manager can act accordingly. Under supervision of the Research Manager, maintain study source documents and regulatory binders. Report adverse events. Primary contact for sub-set of clinical trials with sponsor monitors are onsite. Able to present study documents in a manner to address all monitor questions in regards to clinical trials. Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close out activities. Organize in-person, phone, or online conference meetings with study sponsors and physicians. Ability to organize and respond to deadlines within the study's protocol. Other responsibilities as assigned. JOB KNOWLEDGE
Knowledge of CHV's procedures and systems Knowledge of computer systems and applications Knowledge of clinical research including GCP, HIPPA, fCOI, etc. Able to work independently at multiple offices while maintaining strong communication with the rest of the research team Utilize appropriate grammar, spelling and punctuation Establish and maintain effective working relationships with other employees and the public Communicate and present information effectively Identify problems and work to find appropriate solutions Ability to prioritize tasks and be flexible with changes in schedules Ability to read, understand and follow oral and written instructions Must have valid driver's license and auto insurance SKILLS:
Possesses interpersonal skills necessary to interact with people. Ability to coordinate with various parties participating within a study. Ability to navigate various electronic data capture systems. Ability to navigate electronic medical records systems Data Entry PHYSICAL / MENTAL REQUIREMENTS
Work may require collecting data within a fast-paced hospital setting; requires manual dexterity sufficient to operate a keyboard, calculator, telephone, copier, and fax machine. Vision must be correctable to 20/20 and hearing must be in normal range for telephone contacts. TYPICAL WORKING CONDITIONS
Work is performed in a fast-paced office environment and within the hospital. Involves frequent contact with physicians, clinical staff, hospital staff, study sponsors, and patients. Work may be stressful at times. TEAMWORK
The success of CHV is based upon every member working together to help the team accomplish its goal. Teamwork requires cooperation and a group effort. When CHV's goals are achieved, the individual team members will also benefit. Research relies on working with and supporting the efforts of clinicians and other office professionals, research coordinators are expected to exemplify teamwork. EDUCATION
Bachelor's degree; familiarity with MS office, excel, and an understanding of cardiology. EXPERIENCE REQUIRED
Clinical (particularly cardiovascular) experience required. One to two years experience as clinical research coordinator. Experience as mentor or trainer preferred. Demonstrate strong leadership and problem-solving abilities with high level interpersonal skills. Possess a strong work ethic. Job Type:
Full-time Pay:
$22.00 - $25.00 per hour Benefits:
401(k) Dental insurance Employee discount Health insurance Life insurance Paid time off Vision insurance Work Location:
In person
