Top 38 Clinical study manager Jobs in Houston, Tx

Study Manager I
DM CLINICAL RESEARCH GROUP —Sugar Land, TX
- Customer service
- 5 years
- Writing skills
Clinical Project Manager
Tranquil Clinical and Research Consulting Services LLC —Friendswood, TX
- Full-time
- Nursing
- Computer Science
- Hospital
Quick Apply
Study Start-Up (SSU) Manager
DM CLINICAL RESEARCH GROUP —Houston, TX
- Google Workspace
- Management
- 3 years
8h
Clinical Operations Manager
ALLIANCE CLINICAL LLC —Houston, TX
- $90,000 - $120,000 a year
- Microsoft Word
- CPR Certification
- Microsoft Excel
- Health insurance
- Dental insurance
Quick Apply
Manager, Regulatory Affairs - Clinical Research
Baylor College of Medicine —Houston, TX
- $111,118 - $130,000 a year
- Full-time
- Hybrid work
- Office
- Master's degree
- Bachelor's degree
Clinical Research Coordinator/Rater
Alcanza Clinical Research —Katy, TX
- Full-time
- Spanish
- BLS Certification
- HIPAA
- Health savings account
- Disability insurance
Quick Apply
2d
Clinical Trials/PC Coordinator
Re:Cognition Health Limited —Houston, TX
- $65,000 - $70,000 a year
- Full-time
- Microsoft Excel
- HIPAA
- Mid-level
Quick Apply
9h
Senior Clinical Research Associate - (Multi-Site Coordinator) - Pediatrics
Baylor College of Medicine —Houston, TX
- $70,618 - $83,080 a year
- Full-time
- Mid-level
- Microsoft Office
- Master's degree
Clinical Research Coordinator
Pinnacle Clinical Research —Houston, TX
- Full-time
- Spanish
- Vital signs
- BLS Certification
- Paid holidays
- Disability insurance
Quick Apply
14d
Senior Clinical Research Associate (level dependent on experience)
CTI Clinical Trial Services, Inc —Houston, TX
- Hybrid work
- Nursing
- Mid-level
- Master's degree
- Paid parental leave
- Tuition reimbursement
Quick Apply
Clinical Research Coordinator
Alcanza Clinical Research —Sugar Land, TX
- Full-time
- Spanish
- LVN
- HIPAA
- Health savings account
- Disability insurance
Quick Apply
Research Coordinator III - Research Support Services
Baylor College of Medicine —Houston, TX
- $57,320 - $67,435 a year
- Weekends as needed
- Mid-level
- Bachelor's degree
- Team management
Clinical Research Coordinator (CRC)-FT
Evolution Research Group —Bellaire, TX
- Full-time
- Mid-level
- High school diploma or GED
- Neurology
- Health insurance
- Dental insurance
Quick Apply
2d
Research Coordinator I - Baytown
Houston Methodist Academic Institute —Baytown, TX
- Full-time
- English
- Mid-level
- Residential
Unblinded Clinical Research Coordinator II
DM CLINICAL RESEARCH GROUP —Sugar Land, TX
- Spanish
- Microsoft Outlook
- Customer service
Site Manager
DM CLINICAL RESEARCH GROUP —Houston, TX
- Writing skills
- Mid-level
- Bachelor's degree
1d
Program Manager-Research - Neurology - TIRN
UTHealth Houston —Houston, TX
- RN License
- 5 years
- Bachelor's degree
- Health insurance
- Employee discount
12d
Clinical Research Specialist (Neurology Department)
Houston Methodist Academic Institute —Houston, TX
- Full-time
- Hospital
- Writing skills
- English
8d
Sr Regulatory Compliance Specialist
Houston Methodist Academic Institute —Houston, TX
- Full-time
- Customer service
- 5 years
- English
5d
Program Director - Head & Neck Surgery
MD Anderson —Houston, TX
- $92,500 - $138,500 a year
- Full-time
- Hybrid work
- Surgery
- University
- Bachelor's degree
- AD&D insurance
- Paid holidays
4d

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Study Manager I

DM CLINICAL RESEARCH GROUP -
Sugar Land, TX

Apply Now

Job Details

Qualifications

Customer service
Writing skills
High school diploma or GED

Full Job Description

A Study Manager I is responsible to ensure that quality research is conducted at 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. In addition, ensure study enrollment meets or exceed Sponsors' expectations and 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 certifications on a timely basis.
Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s).
Adherence and compliance to the assigned protocols at their respective site(s).
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
Sponsor-provided and IRB-approved Protocol Training
All relevant Protocol Amendments Training
Any study-specific Manuals Training as applicable
Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.
Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate and timely follow-up on the action items, at their respective site(s).
Make sure that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study-related documents are utilized and implemented at all times for the assigned protocols at their respective site(s).
Working knowledge of the Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for their assigned protocol(s) at their respective site(s)
Creating and or Reviewing Source Documents for their assigned protocol(s) at their respective site(s) in a timely manner.
Responsible for training the site teams and supporting the adequate conduct of study subject visits, and all other relevant protocol required procedures and documenting these in a timely manner.
Responsible for enforcing ALCOA-C Standards with all the relevant clinical trial documentation.
Responsible for enforcing all Adverse and Serious Adverse Events reporting and any other relevant Safety Information reporting to the appropriate authorities per internal company guidelines, Sponsor, IRB and ICH-GCP Guidelines.
Ensuring data quality, subject retention and compliance, and timely and adequate study data reporting on the assigned protocol(s) being conducted at their respective site(s).
Working with the cross-functional team(s) and site team(s) to ensure study start readiness on all the aspects and adequate training completed by all the relevant site staff prior to FPFV and continue working with the cross-functional team(s) for the successful execution and completion of the clinical trial.
Responsible for clinical trial management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs and guidance documents.
Working closely with the Associate Site Director/Site Director to achieve strategic goals for the site.
Assist the Associate Site Director/Site Director with staff training and any other relevant tasks assigned.
Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).
Strive to ensure weekly, monthly and quarterly assigned goals are met for 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
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
Foreign Medical Graduates preferred

Experience:

Minimum of 5 years experience in Clinical Research
Supervisory experience preferred
Wide therapeutic range of clinical trials experience preferred
Regulatory research experience is a plus

Credentials:

ACRP or equivalent certification is preferred

Knowledge and Skills:

Goals-driven while continuously maintaining quality.
Must be detailed-oriented, proactive, and able to take initiative.
Must have strong written and communication skills.
Must have excellent customer service skills.
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

Apply Now

Refine Your Search

clinical study manager jobs in houston, tx

Study Manager I

Clinical Project Manager

Study Start-Up (SSU) Manager

Clinical Operations Manager

Manager, Regulatory Affairs - Clinical Research

Clinical Research Coordinator/Rater

Clinical Trials/PC Coordinator

Senior Clinical Research Associate - (Multi-Site Coordinator) - Pediatrics

Clinical Research Coordinator

Senior Clinical Research Associate (level dependent on experience)

Clinical Research Coordinator

Research Coordinator III - Research Support Services

Clinical Research Coordinator (CRC)-FT

Research Coordinator I - Baytown

Unblinded Clinical Research Coordinator II

Site Manager

Program Manager-Research - Neurology - TIRN

Clinical Research Specialist (Neurology Department)

Sr Regulatory Compliance Specialist

Program Director - Head & Neck Surgery

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