We are actively hiring a Clinical Team Lead (Oncology) to support our Valkyrie Clinical Trials Denver, Colorado site. LOCATION: Onsite FLSA: Non-Exempt HOURS: Monday to Friday, Day Shift, 40 hours per week COMPENSATION: $43.27 - $52.88 per hour (depending on experience) Interrelationships: Works closely with other teams, including nursing, pharmacy, laboratory, study start-up, regulatory, and budgets and contracts personnel to ensure excellence in study conduct and efficient timelines. Will serve as a liaison to sponsor/contract research organizations (CROs) and outside vendors as appropriate. Works closely with principal investigators, sub-investigators, and all staff to ensure participant/patient safety, effective communication, and successful conduct of studies. 3131Represent Flourish in a professional and courteous manner (verbal, written and in appearance) when interacting with staff, sponsors/CROs, IRBs, patients/subjects, nursing and medical staff members of various clinics, hospitals and physicians' offices; 3131Ensure the maintenance of confidentiality by team members of participant/patient information as appropriate and as bound by Confidentiality Agreements between Flourish Research and sponsors/CROs and other entities while abiding by HIPAA regulations; 3131As needed, performs duties as specified in line with a Senior CRC; 3131Coordinate multiple and complex protocols while providing guidance of day-to-day activities of the team; 3131Follow and ensure compliance with SOPs by team members for assigned team; 3131Assist in the review, development, and implementation of SOPs; 3131Assists with evaluating and leading the conduct of studies including accurate and timely entry into EMR, EDC, CTMS, and other systems as required; 3131Provides feedback to Site Director on team and organizational performance; 3131May assist and provide input to Site Director with hiring, performance management, talent planning, and termination decisions; 3131Educate, mentor and provide orientation and ongoing training for Clinical Research staff to ensure qualified personnel. 3131Assists Site Director with coordination of team members' daily/weekly schedules to ensure adequate staffing at all times to meet the demands of assigned protocols and overall team workload; 3131Back-up team members during absences and/or heavy workloads to ensure that work is completed accurately and on time; 3131Schedule and attend meetings to include but not limited to pre-Site Selection Visits, SIVs, CRA/Monitor visits, periodic team meetings, trainings, etc. 3131Provide pertinent communications (written and oral) of sufficient frequency to effectively disseminate information and/or to gain feedback regarding the team's performance and any issues requiring intervention/management; 3131Participate in the start-up and oversee and supervise the conduct and close out of studies assigned to the team; 3131Provide quality control review of participant/patient charts prior to randomization or screen fail to ensure accuracy of status determination; 3131Provide close oversight and review of data collection, data entry as well as protection of data integrity for all studies assigned to the team; 3131Ensure data integrity for all work performed by assigned team members through close oversight and review of source document creation and utilization in the study, of data collection and timely data entry procedures, and by performing quality control reviews of completed work; 3131Assist with oversight of team members to the degree necessary by reviewing/monitoring study-specific logs, internal queries, RealTime CTMS entries, monitoring visit reports/follow-up letters, and by interfacing with sponsor/CRO representatives; 3131Ensure assigned team maintains sufficient supply of lab kits and other study specific supplies; oversee the maintenance of kit storage area to maintain valid kits and disposing of expired materials per sponsor and/or Company policy/protocol 3131Ensure that enrollment goals for all studies assigned to the team are communicated, tracked, and met as appropriate; 3131May provide input to Site Director on budget and contract matters, including during initial study budget creation, review, and amendments; 3131Work closely with the regulatory department to ensure accuracy of informed consent documents, subject/patient stipend, training records and other documents necessary as part of the conduct of clinical research studies; 3131Assist with establishing and maintaining avenues for dissemination of vital communication to the Medical Director/Lead Investigator, Site Director, and other team and department leads; 3131Ensure continuous high-level involvement by principal investigators as required by FDA regulations/ICH guidelines and SOPs by maintaining frequent communications with and training of physician investigators and their staff; 3131Attend meetings and trainings as well as other planning/organizational meetings as required by the Site Director, Regional Director and/or General Manager, and other team department leadership; 3131Represent Flourish Research in a professional and courteous manner (verbal, written and in appearance) when interacting with all staff, clients, and vendors. 3131Additional duties as assigned by management. Requirements PHYSICAL REQUIIREMENTS: 3131Work is normally performed in a typical interior/office work environment; 3131Travel required locally as well as within the continental United States. Travel from time to time may include locations outside of the North American continent; 3131Exposure to human bodily fluids; 3131Laboratory procedures to obtain specimens and processing of specimens; 3131Participant/patient care; 3131Daily computer use. 3131Occasional evening and weekend work schedules. 3131Ability to properly lift thirty-five pounds and occasionally more than thirty-five pounds. 3131Ability to drive and daily availability of an automobile. MINIMUM REQUIREMENTS: Education: Requires aBachelor's degree in a related field or equivalent Certification: Certified Clinical Research Coordinator through an industry recognized professional organization preferred; BLS Certification may be required upon hire. Experience: Minimum of 4 years' experience in clinical research conducting or leading pharmaceutical clinical trials, preferably in the field of oncology; with 1+ years' experience as a team lead or supervisor/manager early phase oncology research experience is a plus. Knowledge and Skills: 3131Consistently demonstrates core values & proficiency of skill sets; 3131Strong technical leadership, critical thinking, and sound decision-making skills; 3131Ability to work independently and as part of a team in a start-up and/or high growth environment; 3131Able to demonstrate current knowledge of federal regulations/ICH guidelines and GCPs, IRB requirements, HIPAA laws, Flourish SOPs, Flourish employee manual and some knowledge of human resource laws; 3131Possess strong clinical skills, i.e. accurate performance of ECGs, vital signs, subject/patient medical history, completion of visit specific source documents, obtain and process laboratory specimens, etc.; 3131Proven ability to handle a large volume of work efficiently and accurately; 3131Ability to organize people and coordinate resources to complete projects in a timely manner and with accuracy; 3131Excellent computer skills to include Office365 products. Demonstrates moderate to high level of computer skills including Microsoft Office, data entry systems utilized by sponsors, Real-Time, and other clinical software; 3131Ability to assist with developing and implementing key initiatives in the department; 3131Demonstrated experience in process improvement to include ability to assist with identifying and implementing process improvements; 3131Seeks out opportunities to help achieve department/company goals; 3131Fosters relationships across teams; 3131Consistently accomplishes at least 80% of individual quarterly goals and objectives; 3131Assists with training and mentoring less experienced staff and new hires; 3131Ability to maintain industry certifications as applicable; 3131Excellent oral and written communication skills; 3131Experience in writing and reviewing Standard Operating Procedures; 3131Strong problem solving, risk assessment and impact analysis abilities; 3131Strong professionalism, negotiation, and conflict management skills; 3131Flexible and able to multi-task and prioritize competing demands; 3131Ability to think independently and influence when appropriate. Benefits Flourish Research offers an excellent comprehensive benefits package to include: Health, dental, and vision insurance plans, 401(k) with a 100% employer match on the first 4% of employee contributions, tuition reimbursement, parental leave, employee referral program, employee assistance program, life insurance, disability insurance, and a generous PTO plan covering vacation, sick, personal days and 8 paid holidays.