35 jobs in Allen Spolden

Chicago, United States | Posted on 12/14/2023

• Industry Pharma/Biotech/Clinical Research
• Work Experience 1-3 years
• City Chicago
• Country United States

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.

• Participate and assist in design and preparation of protocols and case report forms.
• Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
• Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
• Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
• Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
• Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
• Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites.
• Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
• Assist with the maintenance of clinical archive and electronic files.
• Other tasks as assigned.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• BA, BS, RN, BSN or equivalent
• Basic knowledge and adherence to GCPs
• 1-2 years of clinical research experience or equivalent experience or training
• Strong attention to detail
• Ability to multi-task
• Unquestionable integrity and highest ethical standards
• Excellent written and verbal communication skills

New Brunswick, United States | Posted on 02/06/2024

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.

• Participate and assist in design and preparation of protocols and case report forms.
• Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
• Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
• Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
• Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
• Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
• Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites.
• Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
• Assist with the maintenance of clinical archive and electronic files.
• Other tasks as assigned.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• BA, BS, RN, BSN or equivalent
• Basic knowledge and adherence to GCPs
• 1-2 years of clinical research experience or equivalent experience or training
• Strong attention to detail
• Ability to multi-task
• Unquestionable integrity and highest ethical standards
• Excellent written and verbal communication skills

San Francisco, United States | Posted on 04/04/2025

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.

• Participate and assist in design and preparation of protocols and case report forms.
  
• Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
  
• Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
  
• Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
  
• Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
  
• Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
  
• Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites.
  
• Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
  
• Assist with the maintenance of clinical archive and electronic files.
  
• Other tasks as assigned.
  

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• BA, BS, RN, BSN or equivalent
  
• Basic knowledge and adherence to GCPs
  
• 1-2 years of clinical research experience or equivalent experience or training
  
• Strong attention to detail
  
• Ability to multi-task
  
• Unquestionable integrity and highest ethical standards
  
• Excellent written and verbal communication skills
  

New Brunswick, United States | Posted on 12/14/2023

The remote‑based Clinical Trial Associate (CTA) will perform tasks related to supporting operational strategy and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan.

Provide support for essential daily clinical study activities, including regulatory inspection readiness, following established protocols under the general management of the CTA Manager.

Work with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model.

Perform developmental tasks with oversight of CTA Manager.

• For assigned complex, accelerated, and business essential studies, provide support to focus on study startup and site initiation activities, including:
• Approval of study documentation, including essential document packets, study plans, informed consent forms, etc.
• Support oversight of risk-based monitoring.
• Attend important team meetings.
• Support regulatory inspection readiness (e.g. preparation of materials and participation during regulatory inspections.)
• Support additional ad‑hoc activities, as agreed with CTA Manager.
• Work with internal departments (Legal, Insurance, R&D functions), CROs, and vendors.
• Escalate clinical trial insurance issues.
• Support Health Care Provider Engagement for facilitating contracts and meetings.

• Bachelor's degree or equivalent international degree.
• 3 or more years' experience in pharmaceutical industry, clinical research organization, or related role.
• Experience in Phase 2 and 3 studies and global/international studies is advantageous.
• Experience working across multiple therapeutic areas is advantageous.
• Knowledge in global regulatory and compliance requirements for clinical research.
• Excellence in task management and collaboration.
• Requires availability for 5-10% domestic and international travel, including overnight and international travel on an as‑needed basis.

• 401(k) with company match and Annual Retirement Contribution Plan.
• Tuition reimbursement. Company match of charitable contributions.
• Health & Wellness programs including onsite flu shots and health screenings.
• Generous time off for vacation and the option to purchase additional vacation days.

San Diego, United States | Posted on 09/19/2024

• Industry Pharma/Biotech/Clinical Research
• Work Experience 5+ years
• State/Province California
• Country United States

ACCOUNTABILITIES

• Accountable Is responsible for directing and executing research within medicinal chemistry, the development of effective strategies to address key project objectives, and providing creative solutions for medicinal and synthetic chemistry issues to enable the discovery of development candidates.
  
• Makes strategies for research programs in therapeutic areas relevant to NS DDU.
  
• Supports projects by supplying competitive landscape, alliance, collaborative opportunities, and novel technologies.
  
• Participates as an engaged member of a highly interactive Drug Discovery Unit, contributing scientific knowledge and leadership across projects.
  
• Manages chemistry resources (i.e. internal/external FTE, budget, equipment) in one’s function in order to ensure timely achievement of departmental goals.
  
• Leads a group of scientists and develop high-performing teams with an inclusive and innovative culture. A key aspect of the position is to effectively coach, mentor, and develop employees to their maximum potential.
  
• Leads by example with research integrity and work ethic.
  
• Performs other related duties as assigned.
  

CORE ELEMENTS RELATED TO THIS ROLE:

• Represents the science of the company internally and externally.
  
• Contributes to create an open atmosphere from diversified perspectives, deep understanding of the importance of diversity, equity and inclusion, and challenges the status quo without hesitation.
  
• Has willingness to work in a dynamic and changing environment.
  

Minimum Requirements/Qualifications:

Requirements

• Ph.D. in chemistry/ medicinal chemistry with a minimum of 10 years experience in the fields of medicinal chemistry in Drug Discovery, or
  
• MS with 14+ years experience, or
  
• BS with 16+ years experience
  
• 7 years of Industry experience required
  
• 5 years of managerial experience required
  
• A track record of leading project teams to the successful delivery of clinical candidate.
  
• Obtains general knowledge of drug discovery process in preclinical/ clinical stage.
  
• Has demonstrated ability to manage productive and diverse team and has strong leadership/ enterprise thinking.
  
• Has an excellent command of financial aspects of projects.
  
• Publication record, including patents, commensurate with the years of experience.
  
• Possesses drug discovery knowledge and experience for multiple modalities (Protein degrader, peptide, oligonucleotide, protein etc.)
  

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• BA, BS, RN, BSN or equivalent
  
• Basic knowledge and adherence to GCPs
  
• 1-2 years of clinical research experience or equivalent experience or training
  
• Strong attention to detail
  
• Ability to multi-task
  
• Unquestionable integrity and highest ethical standards
  
• Excellent written and verbal communication skills
  
• Self-motivated, assertive, and driven
  
• Comprehensive Healthcare: Medical, Dental, and Vision
  
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
  
• Health & Wellness programs including onsite flu shots and health screenings
  
• Generous time off for vacation and the option to purchase additional vacation days
  
• Community Outreach Programs and company match of charitable contributions
  

Carlsbad, United States | Posted on 04/03/2025

• Industry Nonprofit Charitable Organizations
• Work Experience 5+ years
• City Carlsbad
• State/Province California
• Country United States

Key Accountabilities:

• Coordinate and complete research and development assignments; make sound technical judgments and suggestions.
• Schedule and prepare work in relation to general program schedule.
• Test and evaluate work; confer with senior staff as needed.
• Applies scientific method and experimental design in problem solving.
• Uses scientific expertise to provide solutions to a broad range of difficult problems, solutions should be thorough and practical.
• Maintains accurate, precise, and legible laboratory notebooks.
• Writes reports and technical summaries.
• Prepare technical reports and documentation.
• Provide recommendations for new product development; work to see recommendations through to completion.
• Maintain accurate in-depth knowledge of the scientific principles; keep current on new industry developments.
• Contribute to scientific discussions pertinent to the Company’s products and developmental goals.
• Prepare scientific reports for publications in peer reviewed journals.
• Provide advanced technical support to Manufacturing and Technical Services as needed.
• Ensure and maintain compliance with the Company’s quality system requirements through training and adherence to policies, procedures, and processes.
• Other duties and/or projects as assigned.

Networking/Key relationships:

• Responsible for cross-functional collaboration for technical solutions in new product development and released product support projects.
• Frequent inter-organizational and outside contacts. May represent the company to outside organizations on technical issues.

Minimum Knowledge & Experience Required for the Position:

• Bachelor’s degree (required) and completion of a Ph.D. degree (preferred) in a scientific discipline, or equivalent. Ph.D. in a Biological Science with expertise in hemostasis, hematology, immunology, or cell biology
• Professional assay development experience is preferred
• Minimum of five (5) years previous medical research experience required.

Skills & Capabilities:

• Excellent technical writing and documentation, communication, interpersonal, analytical, and presentation skills are essential.
• Must be able to work with advanced techniques, to modify and/or extend theory and practices.
• Ability to be flexible and to think creatively to problem solve and develop products is essential.
• Computer literacy required; knowledge of Microsoft Office (including extensive Excel skills) and experience with large enterprise resource planning (ERP) and electronic data management systems required.