Regional Clinical Research Manager
Urology America, MSODenver, CO, US8 days ago
Job type
- Full-time
Job descriptionMust have ≥ 5 yrs experience with conducting clinical trials. Urology based clinical experience highly preferred. Bachelor’s degree in a health or science field preferred. Experience with overseeing and conducting pharmaceutical and device study protocols. Must have knowledge of and experience with GCPs and relevant federal and state regulatory guidelines. Excellence in computer software including Microsoft Office Suite, EMR, Practice Management, Electronic Data Capture (EDC), and Clinical Trail Management Systems (CTMS). Exceptional time management skills and the ability to prioritize work. Excellent communication skills and the ability to interact with all levels of management, staff, sponsors, and providers. Work to build and manage research departments in scope, size, reputation, and professionalism and works to accomplish this in all locations and markets assigned. Leads research department staff by conducting training, assigns delegation of responsibilities, supports staff hiring, and manages yearly staff reviews, etc. Oversight and support of CRCs in all markets is a primary responsibility of this role. Assists with patient recruitment for studies, review protocols, completion and submission of feasibility documents, leads trial set-up and launch, plans for and oversees site qualification, initiation, monitoring, audit visits, etc. Supports these endeavors in all locations and markets assigned. Maintain relevant certifications in, and continually update knowledge of, FDA, GCP, ICH, federal and state regulations, etc. Provide relevant updates to other research staff as applicable. Works closely with the IRB / Recruitment Specialist to ensure timely submissions, updates, close-outs, etc. Responsible for maintenance of accurate and complete documentation, primarily executed by the CRCs, including but not limited to regulatory documents, signed informed consent forms, source documentation, drug dispensing logs, subject logs, and study-related communications. Design, implement, and manage system for organizing, planning, and controlling workflow related to all clinical research activities. Work with the EMR and data management systems to complete / monitor completion of EDC, eCRFs, adverse event documentation, maintain patient records, create strategies for patient recruitment. Assist CRCs with identification and prompt reporting of protocol deviations, AEs, and SAEs in accordance with protocol, IRB, and / or sponsor requirements Work closely with IRB, study sponsors, PIs and Sub-Is. Attend necessary meetings and calls. Provide continuous communication on study conduct, pre-study through post-study to all relevant stakeholders, including internal communication regarding enrollment, progress, and completion of trials. Monitor invoicing, billing, and payments, in collaboration with the finance department to ensure timely and accurate A / R process. Create, review, and maintain staff CVs, certifications, etc. Evaluate, purchase, maintain necessary equipment and equipment monitoring. Participate in site visits, SIVs, monitoring, etc. Work directly with patients to support CRCs in screening, consenting, history taking, completing necessary exams including EKG, blood draw, vitals, procedure visits, etc. Complete necessary study close-out steps and documentation. Prepares for and participates in FDA inspections. Communicate with and support patients and their families as necessary. Maintain HIPAA compliant communication and confidentiality, at all times. Assist with other duties assigned. Acts as primary liaison to local market clinic and research department. Knowledge of clinical research in a specialty setting; medical practice clinical and administrative systems, clinical research software, and sponsor requirements for successful clinical trial completion. Understanding of medical terminology. Ability to use multi-line phone systems and relevant computer systems. Interpersonal and communication both with internal staff and external customers. Skill in evaluating and implementing study protocols and budgets. Skill in reading medical chart terminology. Time Management. Ability to communicate effectively with patients, staff, and external contacts via phone, in person, and through electronic mail. Elicit appropriate information for patients to clinic staff. Ability to read and understand information and ideas presented in writing. Ability to apply general rules to specific problems to produce answers that make sense – deductive reasoning. Physical demands : Involves sitting approximately 70-90 percent of the day, walking or standing for the remainder. Work may require stooping and bending, mobility to complete patient study visits, and lifting up to 25 pounds. Work environment : Primarily office setting, with time in the clinical setting for patient study visits. Noise level in the work environment is usually moderate. Clean, well-lighted office / clinical environment. Will require travel between Urology Austin clinical locations and outside Ambulatory Surgery Centers (ASC) to meet study demands.
Job Description
Job Description
Position Summary :
The Regional Clinical Research Manager is responsible for the coordination and administration of clinical trials at 3-4 clinical research site locations within a designated region under the direction of the VP of Operations and Director of Research Strategy and Operations. They are responsible for overseeing clinical research staff to ensure the successful conduct of clinical trials, and ensuring compliance with established regulations and standards.
Job Relationships :
- Reports directly to the Director of Strategy and Operations and indirectly to the Urology America leadership. This role is also responsible to the individual market presidents, the Principal Investigators of each trial, and the physician partners of each practice.
- Collaborates with clinical providers, local vendors, site staff, clinic patient navigators, IT, and data management.
Reporting to this Position : CRC / Operations Leads, Clinical Research Coordinators, Clinical Research Assistants, Interns, other research staff as department grows
Role Qualifications :
Essential Job Duties :
Performance Requirements :
Knowledge
Skills
Abilities
Physical Demands and Work Environment :
The physical demands and work environment characteristics described here are the representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions :
Powered by JazzHR
JugbN4C0wi
Create a job alert for this search
Clinical Research Manager • Denver, CO, US
Related jobs
The Oncology Regional Director will lead a team of seven (7) Oncology Territory Managers (OTMs) for the organization's Solid Tumor Team.
This Regional Director will be responsible for driving the pe...Show moreLast updated: 13 days ago
Rooted in the Hispanic community, The LIBRE Initiative brings people together to advance public policy solutions that create the freedom and opportunity that people need to chase their American Dre...Show moreLast updated: 30+ days ago
All the benefits and perks you need for you and your family : .Student Loan Repayment Program.Whole Person Wellbeing Resources.
Joining AdventHealth is about being part of something bigger.Its about b...Show moreLast updated: 30+ days ago
Solomon Page is seeking a travel nurse RN Med Surg for a travel nursing job in Thornton, Colorado.Job Description & Requirements.
Our client is looking to add a Registered Nurse to their team.Es...Show moreLast updated: 30+ days ago
Hours : 24-32 hours / week administrative and 8-16hours of patient care.Duties : Day to day oversight / management of Clinical Operations.
Overall responsibility of company growth and profitability.Job ...Show moreLast updated: 30+ days ago
Planet Healthcare is seeking a travel nurse RN Med Surg for a travel nursing job in Thornton, Colorado.Job Description & Requirements.
Planet Healthcare Job ID #73209343.Pay package is based on ...Show moreLast updated: 1 day ago
Are you looking for a new leadership opportunity?.In this vital leadership role, you’ll oversee high-quality, patient-centered care while supporting and mentoring a team of clinicians.If you&...Show moreLast updated: 13 hours ago
Clinical Research Coordinator (Contract Position).Open-ended contract (average duration is between 3-6 months).Full-time 40 hours per week (Monday-Friday) - during normal business hours.We are seek...Show moreLast updated: 4 hours ago As a member of Takeda Oncology your work will contribute to our bold, inspiring vision : We aspire to cure cancer.Here you will build a career grounded in purpose and be empowered to deliver your be...Show moreLast updated: 30+ days ago 
Seeking talent near : Kansas City, MO; Oklahoma City, OK; Denver, CO.The Regional Sales Manager (RSM) is responsible for leading, developing, and holding accountable a team of Specialty Sales Specia...Show moreLast updated: 28 days ago
Start a meaningful career as a Clinical Nursing Manager (RN) at Mountain Vista Senior Living in Colorado.Step into a leadership role where your clinical expertise and compassion truly matter.At Mou...Show moreLast updated: 23 days ago
To apply for this position you must be a U.Citizen, you must currently live in the U.FBI background check, and you must be willing to take a drug test.
ForceMetrics™ mission is to transform data for...Show moreLast updated: 30+ days ago The Regional Business Manager LSD leverages strong communication and interpersonal skills with an ability to analyze data and translate into actionable strategies to assist HCPs in the acceleration...Show moreLast updated: 30+ days ago All the benefits and perks you need for you and your family : .Student Loan Repayment Program.Whole Person Wellbeing Resources.
Joining AdventHealth is about being part of something bigger.Its about b...Show moreLast updated: 2 days ago 
UCHealth UCHlth Leprino Building AMC, US : CO : Aurora.Pay is dependent on applicant's relevant experience.Provides technical and scientific leadership for the department's research activities.Collabor...Show moreLast updated: 8 days ago
Abode Home Health is seeking a passionate, dedicated Home Health Clinical Manager to join our team in Denver, CO.In this vital leadership role, you'll oversee high-quality, patient-centered care wh...Show moreLast updated: 30+ days ago
AHS Staffing is seeking a travel nurse RN Med Surg for a travel nursing job in Thornton, Colorado.Job Description & Requirements.
Pay package is based on 12 hour shifts and 36 hours per week (su...Show moreLast updated: 1 day ago
Lighthouse Lab Services is seeking a.This individual will provide strategic leadership for one of the nation’s premier biobank programs, overseeing large-scale biospecimen operations, driving innov...Show moreLast updated: 8 days ago
- Promoted
Oncology Regional Director, Solid Tumors - Northwest Region
Takeda PharmaceuticalsDenver, CO, USFull-time
- Promoted
Regional Field Manager
Stand TogetherDenver, CO, USPart-time
- Promoted
RN Clinical Coordinator OR $10K Sign on Bonus
AH Rocky MountainParker, CO, USFull-time
- Promoted
Travel Med / Surg Telemetry RN
Solomon PageBrighton, CO, USFull-time
- Promoted
Regional Director Clinical Operations needed for Physical Therapy group in the outskirts of Denver (
HealthPlus StaffingBroomfield, CO, USFull-time
- Promoted
Travel Med / Surg Telemetry RN
Planet HealthcareBrighton, CO, USFull-time
- Promoted
- New!
RN Clinical Manager - Home Health
BrightSpring Health ServicesDenver, CO, USFull-time
- Promoted
- New!
Clinical Research Coordinator
ActalentEnglewood, CO, USFull-time
- Promoted
Oncology Territory Manager, Hematology - Denver, CO
Takeda PharmaceuticalsDenver, CO, USFull-time
- Promoted
Neuroscience Regional Sales Manager- Midwest
Acadia PharmaceuticalsDenver, CO, USFull-time
- Promoted
Clinical Nursing Manager (RN)
American Baptist Homes of the MidwestWheat Ridge, CO, USFull-time
Regional Sales Manager
ForceMetricsDenver, CO, USRemote
Full-time
Quick Apply
- Promoted
Regional Business Manager - LSD - Denver, CO
Takeda PharmaceuticalsDenver, CO, USFull-time
- Promoted
RN Clinical Coordinator OR
AH Rocky MountainCastle Rock, CO, USFull-time
- Promoted
Research Nurse Scientist RN Nursing Research
UCHealthLittleton, CO, USFull-time
- Promoted
Clinical Manager - Home Health
BrightSpring Health ServicesDenver, CO, USFull-time
- Promoted
Travel Med / Surg Telemetry RN
AHS StaffingBrighton, CO, USFull-time
- Promoted
Biobanking CLIA Lab Director
Lighthouse Lab ServicesDenver, CO, United StatesPermanent