The Clinical Research Coordinator II - Psychiatry will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC II Psychiatry will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis.

DUTIES & RESPONSIBILITIES

• Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis.
• Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to:
  1. Sponsor-provided and IRB-approved Protocol Training
  2. All relevant Protocol Amendments Training
  3. Any study-specific Manuals Training, as applicable
  4. Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.
• Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner.
• Adherence to ALCOA-C Standards with all the relevant clinical trial documentation.
• Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.
• Demonstration of appropriate and timely follow-up on the action items, at their respective sites.
• Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols.
• Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols.
• Demonstrating adherence and compliance to the assigned protocols at their respective site(s).
• Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s)
• Maintaining a working knowledge of the recruitment and retention process for their assigned protocol(s) at their respective site(s).
• Demonstrating visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s)
• Maintaining a working knowledge of the most recent versions of the Study Protocols, Informed consents, Study Manuals, and all the other relevant study-related documents that are utilized and implemented for the assigned protocols at their respective site(s).
• Oversee reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per internal company guidelines, Sponsor, IRB, and ICH-GCP Guidelines.
• Completing data entry and query resolution in a timely manner as per internal company guidelines and asper sponsor expectations.
• Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).
• Being prepared for and available at all required company meetings.
• Submitting required administrative paperwork per company timelines.
• Occasionally attending out-of-town Investigator Meetings
• Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives
• Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent
• Facilitate effective communication between patients, healthcare providers, and research staff
• Any other matters as assigned by management.

KNOWLEDGE & EXPERIENCE

Education:

• High School Diploma or equivalent required; Bachelor's degree preferred
• Bachelor's degree in Psychology, Neuroscience, Biology, Public Health, Nursing, or a related health science discipline, or a Foreign Medical Graduate with experience in psychiatry.

Experience:

• At least 2 years of experience as a CRC, preferably with practice coordinating industry-sponsored studies in a private setting.
• At least 1 year of experience as a CRC within the fields of psychiatry and behavioral health.
• Demonstrated familiarity with clinical assessment tools, psychometric testing, and psychiatric rating scales, specifically:
  1. Distributing, collecting, and reviewing patient-reported scales (such as EQ-5D, GAD-7, PHQ-9, QID-SR, CSFQ-SF-14, SDS, and WPAI:D).
  2. Administering cognitive and performance batteries (such as Cogstate Battery, DSST, and MMSE).
  3. Administering safety scales (such as C-SSRS, AIMS, BARS, SAS, and Simpson-Angus Rating Scale).

Credentials:

• ACRP or equivalent certification is preferred

Knowledge and Skills

• Be an energetic, go-getter who is detail-oriented and can multi-task.
• Be goals-driven while continuously maintaining quality.
• Proficient communication and comprehension skills both verbal and written in the English language are required.
• Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.

KPI & Success Metrics

• Enrollment & Retention
  1. Enrollment Target Achievement: Percentage of study enrollment goals met per assigned protocol within sponsor-defined timelines.
  2. Screen-Failure Rate Management: Ratio of screen-failures to randomizations, assessing the effectiveness of pre-screening and eligibility assessments.
  3. Retention Rate: Percentage of randomized participants completing study visits as per protocol.
• Data Integrity & Regulatory Compliance
  1. Query Resolution Timeliness: Average time taken to resolve data queries, measured against internal company guidelines and sponsor expectations.
  2. ALCOA-C Adherence: Error rate in clinical trial documentation (based on audit or monitoring visit findings), focusing on compliance with ALCOA-C standards.
  3. Safety Reporting Accuracy: Percentage of Adverse Events (AE) and Serious Adverse Events (SAE) reported to the sponsor, IRB, and regulatory authorities within the mandatory timeframe.
• Protocol Execution & Quality
  1. Monitoring Visit Findings: Total number of major and minor findings/observations noted during sponsor or CRO monitoring visits for assigned protocols.
  2. Training Completion Rate: Percentage of required trainings (Protocol, ICH-GCP, IATA, Electronic Systems) completed prior to study-start or by the specified deadline.
  3. Visit Preparedness: Percentage of study visits where all required procedures, rating scales, and documentation were completed and ready for sponsor review (visit preparedness).
• Communication & Collaboration
  1. Action Item Follow-up: Timeliness and effectiveness of follow-up on action items identified during site visits or team meetings.
  2. Team Liaison Effectiveness: Qualitative feedback from internal (PIs, Lab, Data) and external (CRA, Sponsor) stakeholders regarding the CRC's role in facilitating communication.