Experience working in early development studies Location and Working Environment At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution ...
Experience working in early development studies Location and Working Environment At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution ...
Human Resources Manager
Huntsville, AL ยท On-site
Come work with us and let's build something great together! We are seeking a seasoned Human ... Conducts studies to determine feasibility, cost benefits, and potential HR program applications.
Human Resources Manager
Huntsville, AL ยท On-site
Come work with us and let's build something great together! We are seeking a seasoned Human ... Conducts studies to determine feasibility, cost benefits, and potential HR program applications.
Research Coordinator
Huntsville, AL ยท On-site
$15 - $20/hr
Ability to prioritize and manage multiple studies simultaneously * Dependable, detail-oriented, and self-motivated * Ability to work independently with minimal supervision * Comfortable interacting ...
Quick apply
Research Coordinator
Huntsville, AL ยท On-site
$15 - $20/hr
Ability to prioritize and manage multiple studies simultaneously * Dependable, detail-oriented, and self-motivated * Ability to work independently with minimal supervision * Comfortable interacting ...
Research Coordinator
Huntsville, AL ยท On-site
$15 - $20/hr
Ability to prioritize and manage multiple studies simultaneously * Dependable, detail-oriented, and self-motivated * Ability to work independently with minimal supervision * Comfortable interacting ...
Quick apply
Research Coordinator
Huntsville, AL ยท On-site
$15 - $20/hr
Ability to prioritize and manage multiple studies simultaneously * Dependable, detail-oriented, and self-motivated * Ability to work independently with minimal supervision * Comfortable interacting ...
Come work with us and let's build something great together! We are seeking a seasoned Human ... Conducts studies to determine feasibility, cost benefits, and potential HR program applications.
Come work with us and let's build something great together! We are seeking a seasoned Human ... Conducts studies to determine feasibility, cost benefits, and potential HR program applications.
Research Coordinator
$15 - $20/hr
Ability to prioritize and manage multiple studies simultaneously * Dependable, detail-oriented, and self-motivated * Ability to work independently with minimal supervision * Comfortable interacting ...
Quick apply
Research Coordinator
$15 - $20/hr
Ability to prioritize and manage multiple studies simultaneously * Dependable, detail-oriented, and self-motivated * Ability to work independently with minimal supervision * Comfortable interacting ...
Student Trainee (Human Resources Assistant)
Redstone Arsenal, AL ยท On-site
$33K/yr
Additional credit cannot be given for duplicate course work. * For study at a business or technical school, 36 weeks of study (20+ classroom hours per week) is comparable to 1 academic year above ...
Student Trainee (Human Resources Assistant)
Redstone Arsenal, AL ยท On-site
$33K/yr
Additional credit cannot be given for duplicate course work. * For study at a business or technical school, 36 weeks of study (20+ classroom hours per week) is comparable to 1 academic year above ...
Additional credit cannot be given for duplicate course work. * For study at a business or technical school, 36 weeks of study (20+ classroom hours per week) is comparable to 1 academic year above ...
Additional credit cannot be given for duplicate course work. * For study at a business or technical school, 36 weeks of study (20+ classroom hours per week) is comparable to 1 academic year above ...
Additional credit cannot be given for duplicate course work. * For study at a business or technical school, 36 weeks of study (20+ classroom hours per week) is comparable to 1 academic year above ...
Additional credit cannot be given for duplicate course work. * For study at a business or technical school, 36 weeks of study (20+ classroom hours per week) is comparable to 1 academic year above ...
Student Trainee (Logistics Management)
Redstone Arsenal, AL ยท On-site
$37K/yr
Additional credit cannot be given for duplicate course work. * For study at a business or technical school, 36 weeks of study (20+ classroom hours per week) is comparable to 1 academic year above ...
Student Trainee (Logistics Management)
Redstone Arsenal, AL ยท On-site
$37K/yr
Additional credit cannot be given for duplicate course work. * For study at a business or technical school, 36 weeks of study (20+ classroom hours per week) is comparable to 1 academic year above ...
Student Trainee (Logistics Management)
Redstone Arsenal, AL ยท On-site
$37K/yr
Additional credit cannot be given for duplicate course work. * For study at a business or technical school, 36 weeks of study (20+ classroom hours per week) is comparable to 1 academic year above ...
Student Trainee (Logistics Management)
Redstone Arsenal, AL ยท On-site
$37K/yr
Additional credit cannot be given for duplicate course work. * For study at a business or technical school, 36 weeks of study (20+ classroom hours per week) is comparable to 1 academic year above ...
Student Trainee (Logistics Management)
Redstone Arsenal, AL ยท On-site
$37K/yr
Additional credit cannot be given for duplicate course work. * For study at a business or technical school, 36 weeks of study (20+ classroom hours per week) is comparable to 1 academic year above ...
Student Trainee (Logistics Management)
Redstone Arsenal, AL ยท On-site
$37K/yr
Additional credit cannot be given for duplicate course work. * For study at a business or technical school, 36 weeks of study (20+ classroom hours per week) is comparable to 1 academic year above ...
Systems Modeling & Simulation Engineer, Senior
$103K - $140K/yr
D. with 5 years of experience Extensive experience conducting trade studies or root cause analysis ... work in a secure, onsite environment Active DoD Secret clearance required at start Preferred ...
Systems Modeling & Simulation Engineer, Senior
$103K - $140K/yr
D. with 5 years of experience Extensive experience conducting trade studies or root cause analysis ... work in a secure, onsite environment Active DoD Secret clearance required at start Preferred ...
Systems Modeling & Simulation Engineer, Senior
Huntsville, AL ยท On-site
$97K - $133K/yr
Extensive experience conducting trade studies or root cause analysis involving simulation ... Ability to work in a secure, onsite environment * Active DoD Secret clearance required at start ...
Quick apply
Systems Modeling & Simulation Engineer, Senior
Huntsville, AL ยท On-site
$97K - $133K/yr
Extensive experience conducting trade studies or root cause analysis involving simulation ... Ability to work in a secure, onsite environment * Active DoD Secret clearance required at start ...
Come work with us, and let us build something great together! S is currently seeking a Senior Human ... A Bachelor's degree in Human Resources or a related field of study and 10 years of Human Resources ...
New
Come work with us, and let us build something great together! S is currently seeking a Senior Human ... A Bachelor's degree in Human Resources or a related field of study and 10 years of Human Resources ...
New
CLINICAL RESEARCH RECRUITER (HUNTSVILLE)
Huntsville, AL ยท On-site
$15 - $24.40/hr
May work evenings depending on study needs. * Performs other duties as assigned. Hourly Range : $15.00 - $24.40 Qualifications High School Diploma or GED required. Preferences Hard Skills: Knowledge ...
CLINICAL RESEARCH RECRUITER (HUNTSVILLE)
Huntsville, AL ยท On-site
$15 - $24.40/hr
May work evenings depending on study needs. * Performs other duties as assigned. Hourly Range : $15.00 - $24.40 Qualifications High School Diploma or GED required. Preferences Hard Skills: Knowledge ...
Associate Director, Oncology Epidemiology
Huntsville, AL ยท On-site +1
Conduct literature reviews and synthesis; provide assistance to clinical teams with study design; and identify and evaluate data resources to meet therapeutic needs. * Work closely with colleagues in ...
Associate Director, Oncology Epidemiology
Huntsville, AL ยท On-site +1
Conduct literature reviews and synthesis; provide assistance to clinical teams with study design; and identify and evaluate data resources to meet therapeutic needs. * Work closely with colleagues in ...
Able to establish and maintain good rapport with study respondents * Comfortable working in unfamiliar locations, knocking on doors * Self-motivated, organized, detail-oriented * Ability to work ...
Able to establish and maintain good rapport with study respondents * Comfortable working in unfamiliar locations, knocking on doors * Self-motivated, organized, detail-oriented * Ability to work ...
... ready work. As our clients are often large with complex systems, the Senior Consultant-T&D ... Perform power systems analysis including transmission planning feasibility studies, System Impact ...
... ready work. As our clients are often large with complex systems, the Senior Consultant-T&D ... Perform power systems analysis including transmission planning feasibility studies, System Impact ...
Sr Electrical Engineer
$100K - $131K/yr
This role supports projects up to 345kV Locations & Work Flexibility * Primary location: Mobile, AL ... Pre and postenergization harmonic studies * Shortcircuit and fault current analysis * Bus bar ...
Sr Electrical Engineer
$100K - $131K/yr
This role supports projects up to 345kV Locations & Work Flexibility * Primary location: Mobile, AL ... Pre and postenergization harmonic studies * Shortcircuit and fault current analysis * Bus bar ...
Work Study information
See Athens, AL salary details
$21.2K - $37.4K
1% of jobs
$37.4K - $53.5K
3% of jobs
$53.5K - $69.7K
7% of jobs
$84.1K is the 25th percentile. Wages below this are outliers.
$69.7K - $85.8K
15% of jobs
$85.8K - $102K
9% of jobs
$102K - $118.1K
14% of jobs
The median wage is $119.1K / yr.
$118.1K - $134.2K
17% of jobs
$145.7K is the 75th percentile. Wages above this are outliers.
$134.2K - $150.4K
13% of jobs
$150.4K - $166.5K
11% of jobs
$166.5K - $182.7K
7% of jobs
$182.7K - $198.8K
3% of jobs
$21.2K
$120.9K
$198.8K
How much do work study jobs pay per year?
What are work study jobs?
What jobs make $3,000 a month without a degree?
What is the difference between Work Study vs Intern?
| Aspect | Work Study | Intern |
|---|---|---|
| Credentials | Usually requires enrollment in a college or university | May require enrollment or recent graduation |
| Work Environment | On-campus or related to academic institution | Varies; can be on-site or remote in various industries |
| Employer & Industry | Educational institutions, government, some nonprofits | Businesses, organizations across multiple industries |
| Purpose | Financial aid and work experience for students | Gaining work experience, networking, or exploring careers |
Work Study positions are primarily designed for students enrolled in college, offering financial aid and relevant work experience within academic or related environments. Internships are broader, often targeted at students or recent graduates seeking industry experience across various sectors. While both provide valuable work exposure, Work Study is more focused on supporting education costs, whereas internships emphasize career development.
What are the key skills and qualifications needed to thrive as a Work Study, and why are they important?
How do work study positions typically balance job responsibilities with academic schedules?
Clinical Site Manager (CRA) - SE Region (FL/GA/SC/AL)
Astellas Pharma, Inc.Huntsville, AL โข On-site
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Posted 14 days ago
Job description
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Purpose & Scope
A Clinical Site Manager (CSM) serves as the primary contact point between the Sponsor and the Investigational Site. A CSM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. The Site Manager will manage the site/sponsor relationship as it relates to clinical trial delivery through consistent communication and support. The Site Manager will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial related activities for assigned protocols.
Responsibilities may include assisting with or primary responsibility for:
- Site Selection
- Pre-trial assessment
- Site level Study Participant recruitment/retention plans
- Site Activation/Initiation
- On-site and remote monitoring
- Overall site relationship management in collaboration with other sponsor roles that interact with the site
- Close-out activities
- Reports to the regional Site Management Lead Early or Late-Stage Site Monitoring & Management Organization. This position may provide mentoring to less experienced site managers and may provide oversight for contract team members. A matrix relationship to the study teams is essential in effective execution of this role.
Role and Responsibilities
- Acts as primary local company contact for assigned sites for specific trials. Trials may include both early and late phase clinical trials.
- Develops meaningful site relationships through consistent collaborative communication and engagement.
- May participate in site feasibility and/or pre-trial site assessment visits.
- Attends/participates in investigator meetings as needed.
- May serve as Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study. This assignment ensure study level information is shared with assigned CSMs and has key role in establishing site monitoring strategy for study.
- Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk-based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
- Ensures site staff are trained, and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe.
- Ensure site compliance with study protocol, ICH-GCP, and local/country regulations.
- Ensure ongoing adequacy of site (facilities, staff) for trial conduct.
- Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA.
- Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas.
- Ensures site non-IMP study supplies are adequate for trial conduct.
- Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed.
- Oversees the appropriate destruction of clinical supplies.
- Ensures site staff complete data entry and resolve queries within expected timelines.
- Ensures validity and completeness of data collected at trial sites.
- Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate.
- Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management.
- Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
- Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
- Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.
- Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits.
- Prepares trial sites for close out, conduct final close out visit.
- Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.
- May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.
- May be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols and site activity. Responsible for managing own travel budget within Astellas T & E guidelines.
Required Qualifications
- BA/BS degree with โฅ5years of experience in pharmaceutical related drug development or direct equivalent experience.
- 5 years site monitoring and/or site management experience.
- A minimum of 2 years of Oncology, Ophthalmology, and/or Gene Therapy or other directly relevant therapeutic area experience.
- Strong working knowledge of GCP, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
- Strong critical thinking and problem-solving skills.
- Strong IT skills in appropriate software and company systems.
- Willingness to travel up to 40% with overnight stay away from home.
- Proficient in speaking and writing English. Depending on hiring region, may also be required to be fluent in local language.
- Good written and oral communication.
Preferred Qualifications
- Experience working cross-functionally and in matrix teams
- Experience in executing Lead CSM role
- Experience mentoring more junior site monitors or site managers
- Experience working in early development studies
Location and Working Environment
At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver.
Remote or Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.
What awaits you at Astellas?
- Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
- Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
- Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
- A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Our Organizational Values and Behaviors
Values: Innovation, Integrity and Impact sit at the heart of what we do.
Behaviors: We come together as 'One Astellas,' working with courage and a sense of urgency. We are outcome focused and consistently take accountability for our personal contribution.
Salary Range:
$125,090 - $178,700 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)
Benefits:
- Medical, Dental and Vision Insurance
- Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
- 401(k) match and annual company contribution
- Company paid life insurance
- Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
- Long Term Incentive Plan for eligible positions
- Company fleet vehicle for eligible positions
- Referral bonus program
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