Note: The job is a remote job and is open to candidates in USA. Black Canyon Consulting (BCC) is searching for a Clinical Trials Coordinator to support their work for the National Center for Complementary and Integrative Health (NCCIH). The role involves overseeing coordination of clinical programs, communicating with research participants, and ensuring compliance with regulatory requirements.
Responsibilities
- Oversee coordination between ANPL, ETPB, and clinical programs (pharmacy, inpatient unit, NCCIH OCD, etc.), including schedules, medical coverage, etc
- Communicate with prospective research participants, perform telephone screens, and work with ANPL, ETPB, NCCIH, and NIMH staff to determine eligibility
- Coordinate subject payments, eligibility, calendars, etc
- Complete required clinical trainings and training for study-specific procedures
- Assist with the development of protocol, policies, and procedures
- Assist with documentation and training of new staff on protocol procedures and required competencies
- Participate in protocol development, audits, and required reporting to regulatory bodies and intramural research programs (e.g., FDA, IRB, NIMH, NCCIH)
- Ensure compliance with FDA and IRB requirements for IND protocol
- Provide agendas for weekly team meetings and record minutes as needed
- Contribute to scientific and technical writing including documentation, checklists, and contribution to protocol and manuscripts
- Collaborate with ANPL on related projects, particularly with shared equipment, purchases, and clinical needs
- Monitor study progress and develop benchmarks to ensure performance goals are met
- Develop and maintain spreadsheets to track study progress
- Maintain data and records in compliance with NIH policies and ensure integration with other data systems
- Perform lab research, record, and analyze data, including documentation of test results
- Ensure adherence to timelines
- Document progress using electronic lab notebooks
- Prepare summaries and reports
- Submit orders for supplies, equipment, and training using NIH systems (e.g., POTS)
- Meet weekly with PI, lab members, and clinical staff
Skills
- Oversee coordination between ANPL, ETPB, and clinical programs (pharmacy, inpatient unit, NCCIH OCD, etc.), including schedules, medical coverage, etc
- Communicate with prospective research participants, perform telephone screens, and work with ANPL, ETPB, NCCIH, and NIMH staff to determine eligibility
- Coordinate subject payments, eligibility, calendars, etc
- Complete required clinical trainings and training for study-specific procedures
- Assist with the development of protocol, policies, and procedures
- Assist with documentation and training of new staff on protocol procedures and required competencies
- Participate in protocol development, audits, and required reporting to regulatory bodies and intramural research programs (e.g., FDA, IRB, NIMH, NCCIH)
- Ensure compliance with FDA and IRB requirements for IND protocol
- Provide agendas for weekly team meetings and record minutes as needed
- Contribute to scientific and technical writing including documentation, checklists, and contribution to protocol and manuscripts
- Collaborate with ANPL on related projects, particularly with shared equipment, purchases, and clinical needs
- Monitor study progress and develop benchmarks to ensure performance goals are met
- Develop and maintain spreadsheets to track study progress
- Maintain data and records in compliance with NIH policies and ensure integration with other data systems
- Perform lab research, record, and analyze data, including documentation of test results
- Ensure adherence to timelines
- Document progress using electronic lab notebooks
- Prepare summaries and reports
- Submit orders for supplies, equipment, and training using NIH systems (e.g., POTS)
- Meet weekly with PI, lab members, and clinical staff
Benefits
- Medical, dental, and vision coverage
- A 401(k) plan with employer contribution
- Paid holidays
- Vacation
- Tuition reimbursement
Company Overview