Senior Clinical Research Associate

Senior Clinical Research Associate

ABOUT

Gate Neurosciences, Inc. is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of neuropsychiatric disorders. Our team is deeply committed to improving the lives of patients suffering from neurological and psychiatric diseases, and operates in a dynamic, results-oriented environment. Gate Neurosciences is headquartered in the greater Indianapolis area.

JOB DESCRIPTION

Job Summary:

The Clinical Research Associate will provide support to the Director of Clinical Operations in managing and tracking key study deliverables and milestones. This position will play a key role in contributing to the oversight of the clinical monitoring function across trials. This includes, but is not limited to Primary site monitoring activity, CRO monitoring oversight, developing and implementing best practices in clinical operations, conducting and facilitating data monitoring to ensure consistency and high quality data, and that study deliverables are timely and compliant with the protocol and ICH/GCP guidelines.

Key Responsibilities:

• Conduct site monitoring activities including site evaluation, study start-up, periodic monitoring,  and study close-out of assigned sites.  Will prepare monitoring visit reports.
• Participate in production of pre-study documentation and document and plan review, investigator meetings, and site initiation.
• Ensure timely and accurate study-related communication to internal and external study teams.
• Provide oversight of CRO monitoring activities to ensure good quality, and regulatory and protocol compliance.
• Identify and escalate site risks to the VP of Clinical Operations with suggested mitigation approach.
• Ensure that sites and investigators adhere to the established clinical protocol, regulatory requirements, ICH/GCP, and provide input into data validation.
• As needed, conduct occasional on-site and remote monitoring to ensure consistency and quality across studies, support achievement of company timelines and provide CRO/vendor/contractor oversight and Sponsor level site engagement.
• Review monitoring visit reports and escalate pertinent issues to the Director of Clinical Operations.
• Assist with the development and implementation of site-specific recruitment plans.
• Assist with the review of site reference materials, e.g., screening logs, Delegation of Authority Log, etc.
• Assist with site feasibility, qualification, and selection process; conduct site monitoring visits, and, if performing overmonitoring for a site, manage study monitoring schedule in collaboration with the CRO. 
• Audit CRFs for conformity to source documentation, assesses and improve monitoring performance of CRO.
• Set data entry, monitoring and query resolution related target timelines and oversee adherence to these timelines.
• Manage and help create monitoring and site management related clinical trial tracking metrics and reporting for internal and external collaborators.
• Participate in selection and management/oversight of external vendors and assist in development of vendor specifications.
• Support Director of Clinical Operations with oversight of TMF completeness, timeliness, and quality of filed documents.

Qualifications:

• Bachelor’s degree in Nursing or Pharmacy.
• Minimum 5 years of experience directly supporting clinical research trials in-house for a Biotech/pharmaceutical company or CRO.
• Experience in neuroscience strongly preferred.
• Ability to work independently and within a team-oriented environment with minimal supervision.
• Excellent interpersonal, written, and verbal communication skills.
• Ability to travel at least 20% of time to clinical sites.

LOCATION

Company based in Indianapolis, Indiana office; alternate locations (hybrid/remote work) will be considered.

BENEFITS

·      Health, Dental, Vision and 401(k) from day one

·      401(k) employer match

·      Bonuses

·      Schedule flexibility

·      Competitive paid time off

EQUAL EMPLOYMENT OPPORTUNITY

Gate Neurosciences, Inc. provides equal employment opportunities to all employees and applicants in all company facilities without regard to race, color, religious creed, sex, national origin, ancestry, citizenship status, pregnancy, childbirth, (or related medical conditions, including, but not limited to lactation), physical disability, mental and/or intellectual disability, age, military status or status as a Vietnam-era or special disabled veteran, marital status, registered domestic partner or civil union status, gender (including sex stereotyping and gender identity or expression), medical condition (including, but not limited to, cancer related or HIV/AIDS related), genetic information, or sexual orientation in accordance with applicable federal, state and local laws. 

ACCOMMODATION OF DISABILITIES

Gate Neurosciences, Inc. is committed to making every reasonable effort to accommodate an employee’s disability. An accommodation may be provided if the employee can perform the essential duties of the job, and it does not create an undue hardship for the company. A reasonable accommodation may include changes in the work environment or in the way a job is performed, so a person with a disability may enjoy equal employment opportunities.