COMPENSATION & BENEFITS
- Competitive salary ($90,000 - $100,000/year) commensurate with experience
- Onsite, fulltime (40 hours per week)
- Generous benefits include health insurance, paid parental leave, vacation/sick, and 401k (+ 5% employer match after 1 year).
POSITION SUMMARY The recently established Clinical Research Core at The Buck Institute is looking for an experienced and motivated Clinical Project Manager to coordinate and manage all aspects of complex, multi-component clinical research projects from requirements definition through deployment, identifying schedules, scopes, budget estimations, and implementation plans, including risk mitigation. The successful candidate will work alongside the Clinical Research Director, Dr Newman, an MD PhD and practicing geriatrician, and Associate Director, Dr Brianna Stubbs PhD, who has > 10 years of experience in clinical research. As clinical research is relatively new and rapidly growing at the Buck, the team is small. The successful candidate should expect to provide leadership and be directly engaged in all aspects of the planning, conduct, and reporting of the research as required. KEY RESPONSIBILITIES
- Serve as leader of a study team to design, plan, and execute clinical trials following the study protocol, GCP, ICH Guidelines, and Buck Institute's Clinical Research SOPs.
- Carry out duties with a high degree of self-direction and autonomy, under the overall guidance of Clinical Research Core leadership.
- Implement and coordinate assigned clinical trials both directly and via delegation including regulatory approvals, start-up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, conducting visits, ensuring data is entered promptly, and queries are resolved,
- Apply project management concepts to manage risk and improve quality in the conduct of a clinical research study.
- Incorporate key timelines, endpoints, required vendors, and patient population when planning for each assigned protocol. Develop, coordinate, and implement research and administrative strategies to manage assigned protocols successfully.
- Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, and vendors.
- Mentor and train staff in the conduct of clinical trials, protocol requirements, communication, and trial management skills.
- Ensure staff are delegated. Appropriately trained, and documented.
- Ensure team members apply good documentation practices when collecting and correcting data, transferring data to data capture systems, and resolving queries.
- Ensure confidentiality of patient-protected health information.
- Ensure proper workload distribution and backup support for each research team member, developing and encouraging standardization of processes and procedures
- Develop communication and escalation strategies within teams to ensure patient safety is upheld and all adverse events are followed and reported per the protocol and Buck Institute Clinical Research SOPs.
- Evaluate potential subjects for participation in clinical trials including phone and in-person prescreens.
- Create and execute recruitment strategies in conjunction with patient recruitment staff
- Perform clinical duties (e.g. drug preparation and administration, phlebotomy, ECG, lab processing) within the scope of licensure/practice.
- Promote respect for cultural diversity with participants and staff, and work alongside other team members in culturally competent multilingual recruitment.
Education & Experience
- High School Graduate and/or technical degree and 8+ years of clinical research/project management experience in biomedical or clinical research, OR
- Bachelor’s degree and 4+ years of clinical research/project management experience in biomedical or clinical research, OR
- Master’s or PhD degree and 2+ years of clinical research/project management experience in biomedical or clinical research.
- Experienced in using project management software (e.g. Wrike, MS-Project, RedCap, Medrio)
Skills
- Strong attention to deadlines and budgetary guidelines
- Demonstrated ability to multitask
- Proven success working with all levels of management
- Strong written and verbal communication skills, including excellent presentation skills
- Strong interpersonal skills; able to work independently or as part of a team
- Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative
Desired (not required)
- Professional certification such as PMP or equivalent
- Experience in developing platforms for internal processes
- Phlebotomy
- Experience working on clinical research in a non-profit/academic setting
- Prior supervisory and/or team leadership experience
Please click APPLY to submit your Resume and a Cover Letter indicating why you are a good candidate for this position.