Duties and Responsibilities, including but not limited to:- Team Management & Oversight: Provide strong leadership to the Coordination Team, ensuring all clinical operations are executed at the highest standards. This includes managing a large team of research nurses, coordinators, nuclear medicine coordinators, and other research roles.
- Trial Start-up & Launch: Collaborate closely with the start-up and regulatory team to set and achieve aggressive timelines for the launch of new trials, transferring trials from Start Up Team to Coordination Team. Identify potential barriers early and develop solutions to keep the trial launch on track.
- Recruitment Management: Collaborate with Start Up on the development of recruitment plans for clinical trials. Responsible for successful execution. Monitor recruitment progress, report on outcomes, and, if necessary, lead efforts to adjust recruitment strategies in consultation with the Principal Investigator (PI), Start-Up, Finance, and Director.
- Vendor Management: Responsible for the management of vendors, including radiology, laboratory, and other essential services. Work with the Start-Up Team to identify, evaluate, and onboard new vendors as required by trial demands, ensuring all services meet BAMF's high standards.
- Process Improvement: Drive continuous improvement initiatives across all clinical operations, focusing on enhancing efficiency, reducing errors, and improving patient outcomes. Implement standardized processes and SOPs across the team.
- Culture & Team Development: Foster a culture of excellence, accountability, curiosity, respect, and teamwork within the Clinical Trials Team. Invest time in mentoring and developing team members to ensure high morale and retention.
- Operational Oversight: Oversee daily operations at the Grand Rapids site, ensuring compliance with all regulatory requirements and maintaining the highest standards of patient care.
- Cross-functional Collaboration: Work closely with other BAMF functional groups, including Regulatory and Start Up, Clinic Team, and Finance to ensure cohesive and efficient trial execution.
- Data Integrity & Compliance: Ensure the accuracy and integrity of clinical trial data, maintaining strict compliance with regulatory standards and BAMF's internal policies.
- Strategic Support for Growth: Provide limited but strategic support to BAMF's growth into new sites, ensuring that the Grand Rapids site serves as a model of excellence within the RadioNexus network.
- Reporting & Metrics: Regularly report to the Director of Clinical Trials on key performance indicators, operational challenges, and team dynamics.
Basic Qualifications:- Bachelor's degree in a health-related field or equivalent required
- Minimum of 3 years of experience in clinical trials management or coordination required
- Minimum of 2 years of demonstrated leadership experience, including team leadership, staff mentorship, project oversight, or supervisory responsibilities required
- A working knowledge of ICH-GCP, FDA regulations, informed consent, adverse event reporting and clinical trial documentation required
Preferred Qualifications:- Master's degree in Health Sciences, Clinical Research, Nursing, or a related field preferred
- Oncology, nuclear medicine, or radiopharmaceutical clinical research experience preferred
- Clinical research certification through ACRP or SOCRA (e.g., CCRC, CCRA, ACRP-CP, or CCRP) preferred
- Active Registered Nurse (RN) license or other relevant healthcare professional license preferred
Schedule Details:- Employment Status: Full time (1.0 FTE)
- Hours of work: 8:00 a.m.- 4:30 p.m.
- Days worked: Monday - Friday
At BAMF Health, our top priority is patient care. To ensure we are able to drive a Bold Advance Medical Future, we offer a well-rounded benefit package to care for our team members and their families. Highlights include:
- Employer paid High Deductible Health Plan with employer HSA contribution
- Flexible Vacation Time
- 401(k) Retirement Plan with generous employer match
- Several benefit options including, but not limited to; dental, vision, disability, life, supplemental coverages, legal and identity protection
- Free Grand Rapids downtown parking
