The Sr. Clinical Research Associate (Sr. CRA) will independently manage all clinical aspects of a ... Ensures Trial Master File (TMF) is maintained throughout the study and helps with periodic TMF QC ...
The Sr. Clinical Research Associate (Sr. CRA) will independently manage all clinical aspects of a ... Ensures Trial Master File (TMF) is maintained throughout the study and helps with periodic TMF QC ...
Routinely review ISF and TMF for accuracy, timeliness, and completeness. Request documents from the site, as required. Site Management activities (15-20%) * Act as a primary contact for any questions ...
Routinely review ISF and TMF for accuracy, timeliness, and completeness. Request documents from the site, as required. Site Management activities (15-20%) * Act as a primary contact for any questions ...
Routinely review ISF and TMF for accuracy, timeliness, and completeness. Request documents from the site, as required. Site Management activities (15-20%) * Act as a primary contact for any questions ...
Routinely review ISF and TMF for accuracy, timeliness, and completeness. Request documents from the site, as required. Site Management activities (15-20%) * Act as a primary contact for any questions ...
Routinely review ISF and TMF for accuracy, timeliness, and completeness. Request documents from the site, as required. Site Management activities (15-20%) * Act as a primary contact for any questions ...
Routinely review ISF and TMF for accuracy, timeliness, and completeness. Request documents from the site, as required. Site Management activities (15-20%) * Act as a primary contact for any questions ...
The Senior Clinical Research Associate (Sr CRA) will independently manage all clinical aspects of a ... Ensures Trial Master File (TMF) is maintained throughout the study and helps with periodic TMF ...
The Senior Clinical Research Associate (Sr CRA) will independently manage all clinical aspects of a ... Ensures Trial Master File (TMF) is maintained throughout the study and helps with periodic TMF ...
Clinical Research Assocoate
San Diego, CA · On-site
The Position The Clinical Research Associate (CRA) provides support to Study Lead(s) in clinical ... Routinely monitor TMF inspection readiness for assigned studies * Assist Study Lead with ...
Clinical Research Assocoate
San Diego, CA · On-site
The Position The Clinical Research Associate (CRA) provides support to Study Lead(s) in clinical ... Routinely monitor TMF inspection readiness for assigned studies * Assist Study Lead with ...
Clinical Trial Associate
San Francisco, CA · On-site
$94 - $115/hr
The Clinical Trial Associate will play a key role in supporting day‑to‑day clinical trial ... Support the development, organization, and maintenance of Trial Master File (TMF) documentation.
Clinical Trial Associate
San Francisco, CA · On-site
$94 - $115/hr
The Clinical Trial Associate will play a key role in supporting day‑to‑day clinical trial ... Support the development, organization, and maintenance of Trial Master File (TMF) documentation.
Senior Clinical Research Associate
Los Angeles, CA · Hybrid
$110K - $138K/yr
Senior Clinical Research Associate - Oncology - Southern California ICON is a global healthcare ... Manage site essential document collection and TMF reconciliation with site files * Support sites ...
Quick apply
Senior Clinical Research Associate
Los Angeles, CA · Hybrid
$110K - $138K/yr
Senior Clinical Research Associate - Oncology - Southern California ICON is a global healthcare ... Manage site essential document collection and TMF reconciliation with site files * Support sites ...
Senior Clinical Research Associate
San Diego, CA · Hybrid
$110K - $138K/yr
Senior Clinical Research Associate - Oncology - Southern California ICON is a global healthcare ... Manage site essential document collection and TMF reconciliation with site files * Support sites ...
Quick apply
Senior Clinical Research Associate
San Diego, CA · Hybrid
$110K - $138K/yr
Senior Clinical Research Associate - Oncology - Southern California ICON is a global healthcare ... Manage site essential document collection and TMF reconciliation with site files * Support sites ...
Senior Clinical Research Associate
Los Angeles, CA · Hybrid
$110K - $138K/yr
Senior Clinical Research Associate - Oncology - Southern California ICON is a global healthcare ... Manage site essential document collection and TMF reconciliation with site files * Support sites ...
Senior Clinical Research Associate
Los Angeles, CA · Hybrid
$110K - $138K/yr
Senior Clinical Research Associate - Oncology - Southern California ICON is a global healthcare ... Manage site essential document collection and TMF reconciliation with site files * Support sites ...
Senior Clinical Research Associate
San Diego, CA · Hybrid
$110K - $138K/yr
Senior Clinical Research Associate - Oncology - Southern California ICON is a global healthcare ... Manage site essential document collection and TMF reconciliation with site files * Support sites ...
Senior Clinical Research Associate
San Diego, CA · Hybrid
$110K - $138K/yr
Senior Clinical Research Associate - Oncology - Southern California ICON is a global healthcare ... Manage site essential document collection and TMF reconciliation with site files * Support sites ...
Senior Clinical Research Associate
Los Angeles, CA · Hybrid
$110K - $138K/yr
Senior Clinical Research Associate - Oncology - Los Angeles, CA ICON is a global healthcare ... Manage site essential document collection and TMF reconciliation with site files * Support sites ...
Senior Clinical Research Associate
Los Angeles, CA · Hybrid
$110K - $138K/yr
Senior Clinical Research Associate - Oncology - Los Angeles, CA ICON is a global healthcare ... Manage site essential document collection and TMF reconciliation with site files * Support sites ...
Clinical Trial Management Associate
San Francisco, CA · On-site +1
$100K - $135K/yr
The Clinical Trial Management Associate (CTMA) is a key member of the Clinical Operations team and ... Maintain and QC the Trial Master File (TMF) and ensure documents are filed in a timely and ...
Clinical Trial Management Associate
San Francisco, CA · On-site +1
$100K - $135K/yr
The Clinical Trial Management Associate (CTMA) is a key member of the Clinical Operations team and ... Maintain and QC the Trial Master File (TMF) and ensure documents are filed in a timely and ...
Clinical Trial Management Associate
San Francisco, CA · On-site
$100 - $135/hr
The Clinical Trial Management Associate (CTMA) is a key member of the Clinical Operations team and ... Maintain and QC the Trial Master File (TMF) and ensure documents are filed in a timely and ...
Clinical Trial Management Associate
San Francisco, CA · On-site
$100 - $135/hr
The Clinical Trial Management Associate (CTMA) is a key member of the Clinical Operations team and ... Maintain and QC the Trial Master File (TMF) and ensure documents are filed in a timely and ...
Senior Clinical Research Associate
Los Angeles, CA · Hybrid
$110K - $138K/yr
Senior Clinical Research Associate - Oncology - Los Angeles, CA ICON is a global healthcare ... Manage site essential document collection and TMF reconciliation with site files * Support sites ...
Quick apply
Senior Clinical Research Associate
Los Angeles, CA · Hybrid
$110K - $138K/yr
Senior Clinical Research Associate - Oncology - Los Angeles, CA ICON is a global healthcare ... Manage site essential document collection and TMF reconciliation with site files * Support sites ...
Senior Clinical Research Associate
Los Angeles, CA · On-site +1
$110K - $138K/yr
Senior Clinical Research Associate - Oncology - Los Angeles, CA ICON is a global healthcare ... Manage site essential document collection and TMF reconciliation with site files * Support sites ...
Senior Clinical Research Associate
Los Angeles, CA · On-site +1
$110K - $138K/yr
Senior Clinical Research Associate - Oncology - Los Angeles, CA ICON is a global healthcare ... Manage site essential document collection and TMF reconciliation with site files * Support sites ...
Revolution Medicines is seeking an Associate Director, Clinical Quality Assurance, who will play a ... Provide support for Inspection Readiness activities (e.g., TMF activities, study documentation)
Revolution Medicines is seeking an Associate Director, Clinical Quality Assurance, who will play a ... Provide support for Inspection Readiness activities (e.g., TMF activities, study documentation)
Clinical Trial Associate
$86K - $105K/yr
The Clinical Trial Associate (CTA) supports the Clinical Trial Management team in the execution of ... SOPs and TMF Reference Model standards * Coordinate document review workflows, training ...
Clinical Trial Associate
$86K - $105K/yr
The Clinical Trial Associate (CTA) supports the Clinical Trial Management team in the execution of ... SOPs and TMF Reference Model standards * Coordinate document review workflows, training ...
Clinical Research Associate - Full-Service Syneos Health is a leading fully integrated ... Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician ...
Clinical Research Associate - Full-Service Syneos Health is a leading fully integrated ... Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician ...
Clinical Research Associate - Full-Service Syneos Health is a leading fully integrated ... Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician ...
Clinical Research Associate - Full-Service Syneos Health is a leading fully integrated ... Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician ...
Tmf Associate information
See California salary details
$17.08 - $21.83
4% of jobs
$21.83 - $26.57
8% of jobs
$26.57 - $31.32
12% of jobs
$31.46 is the 25th percentile. Wages below this are outliers.
$31.32 - $36.06
26% of jobs
$36.06 - $40.80
18% of jobs
$42.45 is the 75th percentile. Wages above this are outliers.
$40.80 - $45.55
19% of jobs
$45.55 - $50.29
6% of jobs
$50.29 - $55.04
2% of jobs
$55.04 - $59.78
1% of jobs
$59.78 - $64.53
1% of jobs
$64.53 - $69.27
2% of jobs
$17
$39
$69
How much do tmf associate jobs pay per hour?
What is the difference between Tmf Associate vs Tmf Analyst?
| Aspect | Tmf Associate | Tmf Analyst |
|---|---|---|
| Required Credentials | Bachelor's degree in life sciences, pharmacy, or related fields; basic knowledge of clinical trial processes | Bachelor's or master's degree; deeper understanding of TMF processes and regulatory requirements |
| Work Environment | Clinical research organizations, pharmaceutical companies, or CROs; supporting TMF documentation | More analytical role within similar settings; involved in reviewing and ensuring compliance |
| Employer & Industry Usage | Commonly used in clinical trial documentation teams | Used in quality assurance and compliance teams within the same industry |
The main difference between a Tmf Associate and a Tmf Analyst lies in their experience level and scope of responsibilities. Tmf Associates typically handle documentation support and basic compliance tasks, while Tmf Analysts perform more detailed reviews and analysis to ensure regulatory adherence. Both roles are essential in clinical trial management, with the Analyst position requiring a deeper understanding of TMF processes.

Full-time
Medical, Dental, Vision, Retirement, PTO
Re-posted 7 hours ago
Job description
Structure Therapeutics develops life-changing medicines for patients using advanced structure-based and computational drug discovery technology. The company's platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical-stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.
Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company completed an initial public offering (IPO) in February 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.
Position Summary:
The Sr. Clinical Research Associate (Sr. CRA) will independently manage all clinical aspects of a small to medium-sized clinical study or, with supervision, assume significant management responsibilities on a large-scale study. This position works closely with a cross-functional team, vendors, sites, and CRO to ensure compliance with protocol and the overall clinical trial objectives. Additionally, this role will be responsible for implementing and monitoring clinical study activities to assure adherence to good clinical practices (GCPs), standard operating procedures (SOPs), and study protocols. This role will report to a Sr. CTM or Associate Director. Hybrid SSF preferred with remote considered.
Job Responsibilities
- Serves as a crucial member of the project team for the quality execution of assigned clinical protocols according to SOPs, ICH/GCP, and corporate and departmental program goals.
- Supports the Study Lead as an integral member of a multifunctional team to ensure clinical study activities including study start-up, enrollment, maintenance, and closeout are executed appropriately.
- Participates in protocol development, tracking changes for future protocol amendments, and works with medical writing to initiate protocol amendments as needed.
- Oversees aspects of study management and vendors (e.g. IRT, eCOA, cardiac safety, patient reimbursement vendors) to ensure high quality of data and to ensure study execution and deliverables are met with minimum supervision.
- Overall management of selected clinical sites including acting as a point of escalation and oversight of CRO monitoring activities, which includes monitoring visit report review, contract and budget negotiations with clinical sites. Assists with shipment and reconciliation of Investigational Product (IP) at study and site level as needed.
- Works with the CTA to ensure creation, tracking, distribution, and accuracy of meeting agendas and meeting minutes.
- Participates in the review/ implementation of study design from an operations perspective and implements tactics at a site level.
- May support Study Lead in the review of CRO/Vendor RFPs and participate in bid defenses and review and comment on proposals for vendor selection.
- Supports Study Lead in the development / review of study timelines and budgets and works diligently to meet timelines and deliverables.
- Participates in the development of critical study documents such as informed consent form templates, site management monitoring tools, FAQs, processes, and workflows.
- Participates in the development, distribution, review, and tracking of essential trial documents.
- Strives to ensure timelines and deliverables are met within budget.
- Participates in the development of and ensures compliance with the clinical monitoring plan; monitors as needed for training and quality assurance (QA) purposes.
- Supports the creation and updates on the study plans, Informed Consent Forms, Feasibility Questionnaires, Qualification Visit presentations, Site initiation visit presentations, site-facing materials and tools from initiation to the final study execution.
- Contributes to the case report form (CRF) design process including content, User Acceptance Testing (UAT), form layout, and edit check review.
- Liaises internally to forecast and monitor overall drug supply throughout the trial.
- Supports other study-wide activities as assigned - such as external vendors, sample handling, investigator payments, overall data quality, and overall central records quality.
- Exercises sound judgment to resolve or, as appropriate, seek expert input on protocol and study drug, safety, regulatory, and legal questions.
- Contributes to the SOP review process and/or other Clinical Operations Initiatives
- Ensures Trial Master File (TMF) is maintained throughout the study and helps with periodic TMF QC/audits.
- Practices professionalism and integrity in all actions and relationships with management, supervisors, team members, and vendors. Demonstrates teamwork, cooperation, self-mastery, and flexibility to get the work done.
Qualifications:
Education
- Bachelor's degree in a relevant scientific discipline
Experience
- Minimum 4 years of clinical trial management experience working for a Sponsor company, CRA/field monitor, or CRO setting. Global experience a plus.
- A good understanding of the drug development process, ICH guidelines/GCP and understanding of the clinical trials process, the application of SOPs, and medical terminology.
- Self-motivated and able to motivate others.
- Strong interpersonal, problem-solving, organizational, and planning skills along with excellent verbal and written communication skills
- Strong attention to detail and ability to prioritize tasks to meet critical deadlines.
- Strong proficiency in Microsoft Office and ability to utilize a wide range of computer applications and tools.
- Proficiency in Microsoft suite or products such as Word, Excel etc.
Travel Required: Up to 20%
Structure Therapeutics Inc. is an Equal-Opportunity Employer.
Structure Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $135,000 - $150,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's geography, qualifications, skills, and experience.
At Structure, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Structure Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, unlimited PTO, and a number of paid holidays including winter shutdown.
About Structure Therapeutics
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
51 - 200 Employees
Headquarters location
South San Francisco, CA, US
Year founded
2017