Clinical Team Lead (Oncology)

About the role

Valkyrie Clinical Trials (VCT), a Flourish Research Company, is seeking a Clinical Team Lead (Oncology) to support our Denver, Colorado site. This position will play a crucial role in ensuring the successful conduct of clinical research studies.

Responsibilities

• 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.
• Serves 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.
• Represents 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.
• Maintains 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.
• Performs duties as specified in line with a Senior CRC.
• Covers for team members during absences and/or heavy workloads to ensure that work is completed accurately and on time.
• Ensures 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.
• Assists 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.
• Ensures assigned team maintains sufficient supply of lab kits and other study specific supplies.
• Oversees the maintenance of kit storage area to maintain valid kits and disposing of expired materials per sponsor and/or Company policy/protocol.
• Communicates enrollment goals for all studies assigned to the team to ensure they 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.
• Works 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.
• Affords input to Site Director on hiring, performance management, talent planning, and termination decisions.
• Provides feedback to Site Director on team and organizational performance.
• Attends 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.

Requirements

• Education: Requires a Bachelor's degree in a related field or equivalent.
• 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: 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; 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; 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.

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. 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.