Clinical Team Lead (Oncology) at Flourish Research

Denver, Colorado, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Oct, 26

Salary

52.88

Posted On

06 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research Leadership, Oncology Research, Protocol Coordination, GCP Compliance, Data Integrity Management, Staff Mentoring, SOP Development, Patient Safety Oversight, Clinical Trial Management, Regulatory Compliance, Budget and Contract Review, Quality Control Review

Industry

Biotechnology Research

Description

Valkyrie Clinical Trials (VCT), a Flourish Research Company, is a leading Oncology multi-site clinical research network with expertise in Oncology research. VCT approaches clinical research with a deep sense of humanity, compassion, and sincere kindness. VCT was founded by leading Clinical Oncologist, Dr. David Berz, and has multiple sites spanning California in Century City, Panaroma City, and Murrieta, and has recently expanded to Denver, Colorado. Flourish Research is one of the industry’s most progressive and diversified clinical trial organizations, with strong capabilities across cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU! 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. Represent 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; Ensure 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; As needed, performs duties as specified in line with a Senior CRC; Coordinate multiple and complex protocols while providing guidance of day-to-day activities of the team; Follow and ensure compliance with SOPs by team members for assigned team; Assist in the review, development, and implementation of SOPs; Assists with evaluating and leading the conduct of studies including accurate and timely entry into EMR, EDC, CTMS, and other systems as required; Provides feedback to Site Director on team and organizational performance; May assist and provide input to Site Director with hiring, performance management, talent planning, and termination decisions; Educate, mentor and provide orientation and ongoing training for Clinical Research staff to ensure qualified personnel. Assists 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; Back-up team members during absences and/or heavy workloads to ensure that work is completed accurately and on time; Schedule and attend meetings to include but not limited to pre-Site Selection Visits, SIVs, CRA/Monitor visits, periodic team meetings, trainings, etc. Provide 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; Participate in the start-up and oversee and supervise the conduct and close out of studies assigned to the team; Provide quality control review of participant/patient charts prior to randomization or screen fail to ensure accuracy of status determination; Provide close oversight and review of data collection, data entry as well as protection of data integrity for all studies assigned to the team; Ensure 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; Assist 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; Ensure 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 Ensure that enrollment goals for all studies assigned to the team are communicated, tracked, and met as appropriate; May provide input to Site Director on budget and contract matters, including during initial study budget creation, review, and amendments; Work 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; Assist with establishing and maintaining avenues for dissemination of vital communication to the Medical Director/Lead Investigator, Site Director, and other team and department leads; Ensure 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; Attend 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; Represent Flourish Research in a professional and courteous manner (verbal, written and in appearance) when interacting with all staff, clients, and vendors. Additional duties as assigned by management. PHYSICAL REQUIIREMENTS: Work is normally performed in a typical interior/office work environment; Travel required locally as well as within the continental United States. Travel from time to time may include locations outside of the North American continent; Exposure to human bodily fluids; Laboratory procedures to obtain specimens and processing of specimens; Participant/patient care; Daily computer use. Occasional evening and weekend work schedules. Ability to properly lift thirty-five pounds and occasionally more than thirty-five pounds. Ability 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: Consistently demonstrates core values & proficiency of skill sets; Strong technical leadership, critical thinking, and sound decision-making skills; Ability to work independently and as part of a team in a start-up and/or high growth environment; Able 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; Possess 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.; Proven ability to handle a large volume of work efficiently and accurately; Ability to organize people and coordinate resources to complete projects in a timely manner and with accuracy; Excellent 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; Ability to assist with developing and implementing key initiatives in the department; Demonstrated experience in process improvement to include ability to assist with identifying and implementing process improvements; Seeks out opportunities to help achieve department/company goals; Fosters relationships across teams; Consistently accomplishes at least 80% of individual quarterly goals and objectives; Assists with training and mentoring less experienced staff and new hires; Ability to maintain industry certifications as applicable; Excellent oral and written communication skills; Experience in writing and reviewing Standard Operating Procedures; Strong problem solving, risk assessment and impact analysis abilities; Strong professionalism, negotiation, and conflict management skills; Flexible and able to multi-task and prioritize competing demands; Ability to think independently and influence when appropriate. 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. Flourish Research is an equal employment opportunity employer. Employment decisions are based on merit and business needs, and not on race, color, sex, (including pregnancy and gender identity), citizenship status, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, genetic information, marital status, veteran status, political affiliation, or any other factor protected by law. Flourish Research complies with the law regarding reasonable accommodation for handicapped and disabled employees.

Responsibilities

Lead and coordinate complex oncology clinical trial protocols while supervising a team of clinical research staff. Act as a primary liaison between sponsors, CROs, and internal departments to ensure data integrity and patient safety.