Axsome Therapeutics is seeking a Senior Clinical Research Associate. Reporting to the Senior ... assigned programs ensuring the trial is conducted in compliance with the protocol, ICH/GCP ...
Axsome Therapeutics is seeking a Senior Clinical Research Associate. Reporting to the Senior ... assigned programs ensuring the trial is conducted in compliance with the protocol, ICH/GCP ...
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements. * Proven ability to manage multiple sites and projects ...
Quick apply
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements. * Proven ability to manage multiple sites and projects ...
Equity/Stock option program * Training completion and retention bonus * Annual merit increases ... Clinical Research Associate Experience (minimum 1 year) * Ability to travel 60-70% to locations ...
Equity/Stock option program * Training completion and retention bonus * Annual merit increases ... Clinical Research Associate Experience (minimum 1 year) * Ability to travel 60-70% to locations ...
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements. * Proven ability to manage multiple sites and projects ...
Quick apply
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements. * Proven ability to manage multiple sites and projects ...
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements. * Proven ability to manage multiple sites and projects ...
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements. * Proven ability to manage multiple sites and projects ...
Clinical Research Coordinator
Sugar Land, TX · On-site
$21.75 - $29/hr
A Medical Assistant diploma, LPN/LVN, EMT credential OR Associate's degree AND a minimum of 1 year of clinical research or clinical experience, OR an equivalent combination of education and ...
Clinical Research Coordinator
Sugar Land, TX · On-site
$21.75 - $29/hr
A Medical Assistant diploma, LPN/LVN, EMT credential OR Associate's degree AND a minimum of 1 year of clinical research or clinical experience, OR an equivalent combination of education and ...
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements. * Proven ability to manage multiple sites and projects ...
Quick apply
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements. * Proven ability to manage multiple sites and projects ...
Equity/Stock option program * Training completion and retention bonus * Annual merit increases ... Clinical Research Associate Experience (minimum 1 year) * Ability to travel 60-70% to locations ...
Equity/Stock option program * Training completion and retention bonus * Annual merit increases ... Clinical Research Associate Experience (minimum 1 year) * Ability to travel 60-70% to locations ...
Clinical Research Coordinator
Katy, TX · On-site
$22.25 - $29.50/hr
A Medical Assistant diploma, LPN/LVN, EMT credential OR Associate's degree AND a minimum of 1 year of clinical research or clinical experience, OR an equivalent combination of education and ...
Clinical Research Coordinator
Katy, TX · On-site
$22.25 - $29.50/hr
A Medical Assistant diploma, LPN/LVN, EMT credential OR Associate's degree AND a minimum of 1 year of clinical research or clinical experience, OR an equivalent combination of education and ...
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements. * Proven ability to manage multiple sites and projects ...
Quick apply
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements. * Proven ability to manage multiple sites and projects ...
Clinical Research Coordinator II
Sugar Land, TX · On-site
$21.75 - $29/hr
A Medical Assistant diploma, LPN/LVN, EMT credential OR Associate's degree AND a minimum of 1 year of clinical research or clinical experience, OR an equivalent combination of education and ...
Clinical Research Coordinator II
Sugar Land, TX · On-site
$21.75 - $29/hr
A Medical Assistant diploma, LPN/LVN, EMT credential OR Associate's degree AND a minimum of 1 year of clinical research or clinical experience, OR an equivalent combination of education and ...
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements. * Proven ability to manage multiple sites and projects ...
Quick apply
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements. * Proven ability to manage multiple sites and projects ...
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements. * Proven ability to manage multiple sites and projects ...
Quick apply
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements. * Proven ability to manage multiple sites and projects ...
Clinical Research Coordinator
Houston, TX · On-site
$60 - $85/hr
... programs. Responsible for directing study operations, ensuring regulatory compliance, and ... Research Associates preferred Minimum Years Related Experience: 4-6 Years Physical Demands
Clinical Research Coordinator
Houston, TX · On-site
$60 - $85/hr
... programs. Responsible for directing study operations, ensuring regulatory compliance, and ... Research Associates preferred Minimum Years Related Experience: 4-6 Years Physical Demands
Clinical Research Coordinator
Katy, TX · On-site
A Medical Assistant diploma, LPN/LVN, EMT credential OR Associate's degree AND a minimum of 1 year of clinical research or clinical experience, OR an equivalent combination of education and ...
Quick apply
Clinical Research Coordinator
Katy, TX · On-site
A Medical Assistant diploma, LPN/LVN, EMT credential OR Associate's degree AND a minimum of 1 year of clinical research or clinical experience, OR an equivalent combination of education and ...
Clinical Research Coor
Lubbock, TX · On-site
$20.75 - $27.75/hr
Certified Clinical Research Professional as defined by The Society of Clinical Research Associates ... Enjoy excellent benefits , including paid leave, retirement plans, wellness programs, health ...
Clinical Research Coor
Lubbock, TX · On-site
$20.75 - $27.75/hr
Certified Clinical Research Professional as defined by The Society of Clinical Research Associates ... Enjoy excellent benefits , including paid leave, retirement plans, wellness programs, health ...
A Medical Assistant diploma, LPN/LVN, EMT credential OR Associate's degree AND a minimum of 1 year of clinical research or clinical experience, OR an equivalent combination of education and ...
Quick apply
A Medical Assistant diploma, LPN/LVN, EMT credential OR Associate's degree AND a minimum of 1 year of clinical research or clinical experience, OR an equivalent combination of education and ...
West Coast Clinical Research Associate II ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As ...
West Coast Clinical Research Associate II ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As ...
Senior Clinical Research Coordinator
Dallas, TX · On-site
$22.50 - $29.75/hr
... program. Summary: Subject matter expert and leader of a clinical trial team to conduct and manage ... Associate's degree and 6 years as a Clinical Research Coordinator OR * High School Graduate and/or ...
Senior Clinical Research Coordinator
Dallas, TX · On-site
$22.50 - $29.75/hr
... program. Summary: Subject matter expert and leader of a clinical trial team to conduct and manage ... Associate's degree and 6 years as a Clinical Research Coordinator OR * High School Graduate and/or ...
Clinical Research Coor
Lubbock, TX · On-site
$20.75 - $27.75/hr
Research program enrollment: Assist with research subject enrollment by completing all necessary ... Certified Clinical Research Professional as defined by The Society of Clinical Research Associates ...
Clinical Research Coor
Lubbock, TX · On-site
$20.75 - $27.75/hr
Research program enrollment: Assist with research subject enrollment by completing all necessary ... Certified Clinical Research Professional as defined by The Society of Clinical Research Associates ...
Clinical Research Associate Bridge Program information
See Texas salary details
$11.20 - $16.08
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$27.17 is the 25th percentile. Wages below this are outliers.
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2% of jobs
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1% of jobs
$11
$38
$64
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Full-time
Posted 17 days ago
Key responsibilities
Perform clinical monitoring activities including site evaluation, initiation, interim monitoring visits, remote and close-out visits to ensure protocol compliance.
Create monitoring visit reports and verify essential documents and study updates are maintained in the Investigator Site File.
Act as primary point of contact for investigational sites, escalate issues as necessary, and support site evaluation, training, and performance assessment.
Job description
About This Role:
Axsome Therapeutics is seeking a Senior Clinical Research Associate. Reporting to the Senior Manager of Clinical Monitoring, the Senior CRA will be responsible for site management and monitoring activities at assigned sites across assigned programs ensuring the trial is conducted in compliance with the protocol, ICH/GCP, applicable regulatory requirements and applicable SOPs/Work Instructions.
This is a field-based position covering Texas.Candidates must reside within the geography.
Job Responsibilities and Duties include, but are not limited to, the following:
- Assist with the execution and the timely implementation of clinical research activities for assigned projects
- Perform clinical monitoring activities (site evaluation, initiation, interim monitoring visits, remote and close-out) and provide overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
- Monitor investigative sites and activities to verify the protocol is being followed and study activities are being performed by sites
- Create thorough monitoring visit reports
- Act as primary point of contact for assigned investigational sites and cross functional teams and escalate to the study team as necessary
- Perform and may lead in-house review of clinical data listings for completeness and accuracy and escalate issues to the Lead CRA or CTM and Study Director as needed
- Responsible for verifying essential documents and study newsletters are present in the Investigator Site File and tracking/reporting of recruitment updates for their assigned sites
- Participate in the evaluation and training of investigative sites
- Assist with the organization and management of internal team meetings, investigator meetings, and other trial specific meetings as required
- Maintain completion of required corporate training on standards, policies, and work instructions
- May conduct CRA assessments and complete thorough assessment reports
- May act as a Lead CRA(LCRA) to support the development/review of clinical study plans, presentations or project/study-related documents related to monitoring activities including assisting the study team with the day-to-day management of clinical studies
- May act as a LCRA to track site performance metrics and provide oversight of CROs, internal /contract CRA(s) and vendors, including being a liaison for cross-functional teams
- May act in a LCRA role capacity to be responsible for the management of the Monitoring Visit Report (MVR) review, resolution, and escalation
- May act in a LCRA role, to be responsible for training, mentoring, or supervising junior level staff
- May participate in co-monitoring, and/or training visits with team members for training purposes
- Perform other work-related duties as assigned and under the direction of the Clinical Trial Manager or Director
- Additional responsibilities as assigned
Requirements / Qualifications
- Minimum of 5 years of clinical trial experience in a pharmaceutical, biotechnology, CRO, and/or healthcare setting (including 5+ years on-site monitoring experience)
- BA/BS or equivalent degree in a scientific discipline or related healthcare field is preferred but not required
- Demonstrate core understanding of medical terminology or clinical trial activities
- Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, required
- Ability to work on complex or multiple projects and exercise critical thinking with minimal supervision
- Excellent team player with team building skills, willingness, and ability to fill functional gaps in a small but growing organization
- Ability to establish priorities, excellent sense of urgency and desire to collaborate (interpersonal, relationship management) with the study team, cross functional team members and external partners/vendors
- Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities
- Willingness to travel (up to 70%)
Experience and Knowledge:
- Experience in interactions with outside vendors, e.g., CROs and other vendors preferred
- Experience in CNS preferred
- Computer skills including proficiency in the use of Microsoft Office, CTMS, eTMF and eCRF platforms and organization tools
- Demonstrate problem solving and leadership skills
- Solid attention to detail with proven organizational abilities, and excellent written and oral communication and presentation skills
- Solid interpersonal skills and communication skills (both written and oral)
- Self-motivated and adaptable to a dynamic environment
About Axsome Therapeutics
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
1 - 10 Employees
Headquarters location
NY, US
Year founded
2012