The Senior CRA may also participate in monitoring oversight activities such as CRO oversight visits, internal CRA training and evaluation visits, and CRO monitoring visit report review. Essential Job ...
The Senior CRA may also participate in monitoring oversight activities such as CRO oversight visits, internal CRA training and evaluation visits, and CRO monitoring visit report review. Essential Job ...
Pharmacist ED FT
Morehead City, NC · On-site
$53.25 - $64/hr
... monitoring, oversight of administration, and billing. This practitioner will be primarily based in the Emergency Department and may cross-cover other areas as needed. The pharmacist's focus is on the ...
Pharmacist ED FT
Morehead City, NC · On-site
$53.25 - $64/hr
... monitoring, oversight of administration, and billing. This practitioner will be primarily based in the Emergency Department and may cross-cover other areas as needed. The pharmacist's focus is on the ...
Senior Medical Director
South San Francisco, CA · On-site
$324K - $409K/yr
These activities may include, but are not limited to, leading medical monitoring oversight across lead development programs, assist in study design and conduct, participating in key regulatory ...
Senior Medical Director
South San Francisco, CA · On-site
$324K - $409K/yr
These activities may include, but are not limited to, leading medical monitoring oversight across lead development programs, assist in study design and conduct, participating in key regulatory ...
Clinical Trial Manager
$130K - $150K/yr
The CTM will oversee site management, monitoring oversight, and clinical trial operations activities to ensure compliance with GCP, regulatory requirements, and company SOPs. In this role, you will ...
Clinical Trial Manager
$130K - $150K/yr
The CTM will oversee site management, monitoring oversight, and clinical trial operations activities to ensure compliance with GCP, regulatory requirements, and company SOPs. In this role, you will ...
Senior Clinical Monitoring Lead
$162K - $223K/yr
Minimum of 5 years in CRA management, mentoring, or monitoring oversight. * Strong understanding of ICH-GCP, FDA/EMA regulations, and global clinical trial guidelines. * Demonstrated experience in ...
Senior Clinical Monitoring Lead
$162K - $223K/yr
Minimum of 5 years in CRA management, mentoring, or monitoring oversight. * Strong understanding of ICH-GCP, FDA/EMA regulations, and global clinical trial guidelines. * Demonstrated experience in ...
Pharmacist ED FT
$53.25 - $64/hr
... monitoring, oversight of administration, and billing. This practitioner will be primarily based in the Emergency Department and may cross-cover other areas as needed. The pharmacist's focus is on the ...
Pharmacist ED FT
$53.25 - $64/hr
... monitoring, oversight of administration, and billing. This practitioner will be primarily based in the Emergency Department and may cross-cover other areas as needed. The pharmacist's focus is on the ...
Safety Monitoring: Oversight of CMU installation, scaffold erection/dismantling, crane rigging, forklift operation, safe lifting techniques, repetitive motion activities, PPE, etc. Experience Level:
Safety Monitoring: Oversight of CMU installation, scaffold erection/dismantling, crane rigging, forklift operation, safe lifting techniques, repetitive motion activities, PPE, etc. Experience Level:
Safety Representative
Boise, ID · On-site
$40/hr
Must access scaffolding daily, with wall heights exceeding 60 feet, and be highly familiar with our Fraco and conventional systems. • Safety Monitoring: Oversight of CMU installation, scaffold ...
Safety Representative
Boise, ID · On-site
$40/hr
Must access scaffolding daily, with wall heights exceeding 60 feet, and be highly familiar with our Fraco and conventional systems. • Safety Monitoring: Oversight of CMU installation, scaffold ...
Provide abatement monitoring/oversight/clearance sampling. * Prepare scope proposals for clients. Qualifications: * Associate's degree, or equivalent preferred; however, proven experience may be ...
Quick apply
Provide abatement monitoring/oversight/clearance sampling. * Prepare scope proposals for clients. Qualifications: * Associate's degree, or equivalent preferred; however, proven experience may be ...
Program Monitor / Driver
Pottsville, PA · On-site
$16.50/hr
Program Monitoring & Oversight • Guide and supervise resident movements inside and outside of the facility. • Assist residents with indoor and outdoor leisure activities and smoking breaks. • ...
Program Monitor / Driver
Pottsville, PA · On-site
$16.50/hr
Program Monitoring & Oversight • Guide and supervise resident movements inside and outside of the facility. • Assist residents with indoor and outdoor leisure activities and smoking breaks. • ...
Clinical Trial Manager
Houston, TX · On-site
$130K - $150K/yr
The CTM will oversee site management, monitoring oversight, and clinical trial operations activities to ensure compliance with GCP, regulatory requirements, and company SOPs. In this role, you will ...
Clinical Trial Manager
Houston, TX · On-site
$130K - $150K/yr
The CTM will oversee site management, monitoring oversight, and clinical trial operations activities to ensure compliance with GCP, regulatory requirements, and company SOPs. In this role, you will ...
Senior Program Management Analyst
Fort Belvoir, VA · On-site
$131K - $131K/yr
Assists in the financial/program monitoring, oversight, and reporting (e.g., personnel travel, tracking commitments, obligations and expenditures, contractor cost data, burn rates, trends, shortfalls ...
Quick apply
Senior Program Management Analyst
Fort Belvoir, VA · On-site
$131K - $131K/yr
Assists in the financial/program monitoring, oversight, and reporting (e.g., personnel travel, tracking commitments, obligations and expenditures, contractor cost data, burn rates, trends, shortfalls ...
Director of Compliance and Risk Management
Springfield, NJ · On-site
$110K - $135K/yr
Performs oversight and at times review, monitoring, and analysis of various reports, logs, and transaction data to identify trends, unusual activity, and monitor large currency activity; oversees the ...
Director of Compliance and Risk Management
Springfield, NJ · On-site
$110K - $135K/yr
Performs oversight and at times review, monitoring, and analysis of various reports, logs, and transaction data to identify trends, unusual activity, and monitor large currency activity; oversees the ...
Safety Representative
Boise, ID · On-site
$40/hr
Must access scaffolding daily, with wall heights exceeding 60 feet, and be highly familiar with our Fraco and conventional systems. • Safety Monitoring: Oversight of CMU installation, scaffold ...
Quick apply
Safety Representative
Boise, ID · On-site
$40/hr
Must access scaffolding daily, with wall heights exceeding 60 feet, and be highly familiar with our Fraco and conventional systems. • Safety Monitoring: Oversight of CMU installation, scaffold ...
OVERVIEW The Technical Project Manager Support Analyst will support a platform to allow OHT to standardize the standing up and monitoring/oversight of projects in the VHA portfolio. Responsibilities:
OVERVIEW The Technical Project Manager Support Analyst will support a platform to allow OHT to standardize the standing up and monitoring/oversight of projects in the VHA portfolio. Responsibilities:
Director of Compliance and Risk Management
$110K - $135K/yr
Performs oversight and at times review, monitoring, and analysis of various reports, logs, and transaction data to identify trends, unusual activity, and monitor large currency activity; oversees the ...
Director of Compliance and Risk Management
$110K - $135K/yr
Performs oversight and at times review, monitoring, and analysis of various reports, logs, and transaction data to identify trends, unusual activity, and monitor large currency activity; oversees the ...
Responsible for all daily reporting and providing timely deliverables and performance related data to allow for adequate monitoring, oversight, and performance measurement. Adequate knowledge of ...
Responsible for all daily reporting and providing timely deliverables and performance related data to allow for adequate monitoring, oversight, and performance measurement. Adequate knowledge of ...
PR · On-site
Steam Sampling Collection & Environmental Monitoring Perform sample collection and quality monitoring oversight of PR05 Utilities Systems (e.g., water systems, steam, compressed gases) and the ...
Quick apply
PR · On-site
Steam Sampling Collection & Environmental Monitoring Perform sample collection and quality monitoring oversight of PR05 Utilities Systems (e.g., water systems, steam, compressed gases) and the ...
Clinical Research Associate 3
Durham, NC · On-site
$50 - $62/hr
This role combines traditional site monitoring responsibilities with broader sponsor oversight activities, including identification of operational and quality risks, collaboration with CRO partners ...
Quick apply
Clinical Research Associate 3
Durham, NC · On-site
$50 - $62/hr
This role combines traditional site monitoring responsibilities with broader sponsor oversight activities, including identification of operational and quality risks, collaboration with CRO partners ...
Clinical Research Associate 3
$50.02 - $62.53/hr
This role combines traditional site monitoring responsibilities with broader sponsor oversight activities, including identification of operational and quality risks, collaboration with CRO partners ...
Quick apply
Clinical Research Associate 3
$50.02 - $62.53/hr
This role combines traditional site monitoring responsibilities with broader sponsor oversight activities, including identification of operational and quality risks, collaboration with CRO partners ...
Monitoring Oversight information
What is the difference between Monitoring Oversight vs Compliance Analyst?
| Aspect | Monitoring Oversight | Compliance Analyst |
|---|---|---|
| Required Credentials | Certifications like CAMS, CFE, or relevant industry training | Certifications such as CCEP, CRCM, or similar compliance credentials |
| Work Environment | Financial institutions, regulatory agencies, or corporate compliance teams | Financial services, healthcare, or corporate compliance departments |
| Employer & Industry Usage | Used to oversee ongoing monitoring activities and risk management | Used to analyze and ensure adherence to regulations and policies |
Monitoring Oversight focuses on supervising ongoing monitoring processes and risk management, while Compliance Analysts primarily analyze and ensure adherence to specific regulations. Both roles require compliance-related certifications and are integral to regulatory environments, but Monitoring Oversight emphasizes oversight functions, whereas Compliance Analysts focus on compliance analysis and reporting.
What are some common challenges faced by professionals in Monitoring Oversight roles, and how can they be addressed?
What is Monitoring Oversight?
What are the key skills and qualifications needed to thrive as a Monitoring Oversight Specialist, and why are they important?

Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Posted 11 days ago
Job description
The Senior Clinical Research Associate (Sr. CRA) will participate in the preparation and execution of Phase 1-3 clinical trials. The Sr. CRA oversees the progress of clinical investigations by conducting site qualification, initiation, interim, and close-out visits. The Sr. CRA monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by Crinetics Pharmaceuticals and partner CRO(s). The Sr. CRA works closely with the Clinical Trial Manager (CTM) and Clinical Monitoring management to ensure all monitoring activities are conducted according to study requirements. The Senior CRA may also participate in monitoring oversight activities such as CRO oversight visits, internal CRA training and evaluation visits, and CRO monitoring visit report review.
Essential Job Functions and Responsibilities:
These may include but are not limited to:
- Develop strong, collaborative investigational site relationships and ensure continuity of relationships through all stages of the trial.
- Perform clinical study site management/monitoring activities efficiently in compliance with GCP/ICH requirements, SOPs, local laws and regulations, protocol, Clinical Monitoring Plan, and associated documents.
- Participate and provide input on site selection and site qualification activities.
- Coordinate and manage assigned tasks in collaboration with the study team to achieve site activation.
- Perform remote and on-site monitoring activities using various tools to ensure subject rights, safety and well-being are protected as well as the reliability and integrity of study data.
- Conduct site visits including but not limited to qualification visits, initiation visits, interim monitoring visits, and close-out visits; generate clear, comprehensive, and accurate visit reports and letters in a timely manner.
- Review and verify study records including source documents, case report forms, informed consent forms and other materials to ensure data is complete and accurate.
- Interact with the clinical study sites to resolve data queries and/or data entry errors and obtain additional information on potential serious adverse events.
- Assess and monitor investigational product receipt, storage, administration, accountability and return processes.
- Collect, review, and monitor essential regulatory documentation maintained by the site for study start-up, study maintenance, and study close-out.
- Submit site essential documents to the TMF following inline quality review and resolve any quality issues related to submitted documents.
- Train and assist site coordinators, investigators, and CRO (as applicable) in collecting data and executing the study in a timely manner that meets the protocol requirements and timelines/milestones; serve as a resource to site coordinators, investigators and other staff members regarding investigational products and protocols.
- Communicate and document contacts with investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, adverse event reporting, site audits/inspections, and overall site performance.
- Identify, assess, and resolve site performance, quality or compliance problems and escalate as needed per defined escalation pathway in collaboration with CTM and/or Clinical Monitoring management.
- Assist in the development and implementation of subject enrollment and recruitment strategies for site.
- Manage and maintain visit information such as site/subject visit tracking and other documentation in Clinical Trial Management System (CTMS), Trial Master File (eTMF) and other systems.
- Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, office and travel expense submissions and approvals as needed).
- Ensure internal and study-related trainings are completed per study timelines.
- Ensure all study deliverables are completed per Crinetics and study timelines.
- Perform other Clinical Operations duties, as requested.
These activities may be performed by the Senior Clinical Research Associate depending on study assignment:
- Review protocols, eCRFs, study manuals and other related documents, as requested by the CTM and Clinical Monitoring management.
- Conduct CRA monitoring assessment visits, as needed.
- Conduct co-monitoring, data collection visits with Crinetics or CRO CRAs, as needed.
- Provide training/mentoring on operational tasks/projects to more junior staff.
- Conduct monitoring oversight visits (MOVs) with CRO CRAs to assess compliance to the protocol and Clinical Monitoring Plan and document results of the visit.
- Review monitoring visit reports from CRO and escalate monitoring trends or findings to the CTM and Clinical Monitoring management.
Education and Experience:
Required:
- BS in biological sciences or related discipline with at least 5 years of experience in the role of Clinical Research Associate (an equivalent combination of experience and education may be considered).
- Demonstrate an in-depth understanding of the study protocol and related procedures.
- Demonstrate critical thinking, root cause analysis and problem solving to identify site process failures; develop corrective and preventative actions to bring sites into compliance.
- Ability to motivate clinical site personnel to compliantly maintain/accelerate timelines to achieve clinical operational milestones.
- An understanding and demonstrated application of Good Clinical Practices, ICH Guidelines and regulatory requirements. Able to comply with safety standards and respect privacy and confidentiality.
- Excellent writing skills as they relate to the preparation of clinical trial documents.
- Excellent interpersonal skills with strong oral/written communication and presentation skills.
- Excellent negotiation skills and a tactful approach that leads to high value on services obtained and outcomes achieved.
- Well versed with the latest trends in the clinical trial industry.
Preferred:
- Monitoring experience in startup, execution and close out activities related to clinical studies; experience using risk-based monitoring processes preferred.
Physical Demands and Work Environment:
Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Travel:
You may be required to travel for up to 75% of your time.
Equal Opportunity Employer:
Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.
Salary Range
The salary range for this position is: $119,000 - $149,000.
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.
About Crinetics Pharmaceuticals
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
11 - 50 Employees
Headquarters location
San Diego, CA, US
Year founded
2008