2,090 Clinical Trials jobs in the United States

The Alaka`ina Foundation Family of Companies (FOCs) is looking for a qualified Clinical Trials Manager to support our government client in Silver Spring, Maryland. This is not a remote position. The ideal candidate must be within reasonable commuting distance to provide onsite support.

Description of Responsibilities:

• Reports directly to the Program Manager.
• Manages all aspects of a clinical trial from pre-study to study close-out for entities such as drug companies, private physicians, academic institutions, and government agencies.
• Defines the trial budget and schedule.
• Reviews clinical research protocols for compliance, logistical support, and to ensure adequate staffing is available and scheduled appropriately.
• Oversees the screening and qualification of potential study subjects.
• Collects and reviews clinical data and ensures that all information needed to achieve the trial objective is obtained (i.e. review source documents, ensure data is entered correctly).
• Monitors progress of the trial and reports any issues to the trial director or physician.
• Trains, supervises, and tracks training requirements for trial staff and ensures that procedures are executed correctly.
• Reviews and updates all Standard Operating Procedures (SOPs) as required.
• Provides back-up coverage for any position to include but not limited to CRC, phlebotomist, recruiter, and administrative assistant.
• Provides and/or coordinates all contractually required reports.
• May be required to work evenings, weekends, and/or occasional nights. Typical work schedule is M-F 6:00AM - 2:30PM.
• Other duties as assigned by Supervisor.

Required Degree/Education/Certification:

• Registered Nurse with five (5) years of experience in Clinical Research.
• Maintain Certification in Clinical Research Coordination by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA).
• Basic Life Support (BLS -CPR/ AED) certification.

Required Skills and Experience:

• Solid regulatory-affairs experience is required, preferably related to vaccine research (i.e - Phase I vaccine prep/mixing).
• Must be able to work independently following a brief period of specific technical training.
• Ability to establish and maintain effective working relationships with coworkers, managers, and customers.
• Knowledge of applicable highly complex scientific procedures and techniques relating to position.

Desired Skills and Experience:

• Advanced Cardiac Life Support (ACLS) certification encouraged.

Required Citizenship and Clearance:

• Must be a U.S. Citizen
• Must be able to pass a background check for a NACI.

The Alakaina Foundation Family of Companies (FOCs) is a fast-growing government service provider. Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 11 paid holidays.

We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We are proud to state that we do not illegally discriminate in employment decisions on the basis of any protected categories. If you are a person with a disability and you need an accommodation during the application process, please click here to request accommodation. We E-Verify all employees.

COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE! Hybrid work arrangement Medical, Dental, Vision Benefits Health Savings Account (HSA), Flexible Spending Account (FSA) Prescription Drug Coverage Telehealth and Behavior Health Services Income Protection – Short Term and Long Term Disability Benefits Retirement Benefits - 401k Company Match on Day One (100% vesting immediately) Group Life Insurance Wellness Programs Corporate Discounts on personal services: Cellular phones, Entertainment, and Consumer Goods! Sun Pharma Vision: Reaching People And Touching Lives Globally As A Leading Provider Of Valued Medicines Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over $4.5 billion US Dollars. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe including the United States. Sunology is a combination of Sun Values and Ideology and is the way of life at Sun Pharma. Sunology is Humility. Integrity. Passion. Innovation. It represents our promise to all stakeholders including patients, physicians, and employees. Our Code of Conduct Our Global Code of Conduct governs every aspect of our operations. Sun Pharma is a family of thousands of people, working across many countries, speaking multiple languages, and all united, with one common purpose: to make good health accessible and affordable to local communities and society at large. Through active fieldwork, dedicated research teams, and in recognition of the efforts who work behind the scenes to combat illness and disease, the Sun Pharmaceutical Group helps as many people as possible, to secure their right to good health. The way we work every day is important to us. Sun Pharma Advanced Research Company (SPARC) is a pharmaceutical research and drug discovery organization that was formed in 2007 when SUN Pharmaceutical Industries Ltd separated out its active projects in drug discovery and innovation into a new company to provide the focus and the opportunity for growth of these projects which are now at different stages of preclinical and clinical development. The Clinical Trial Associate will: Customize, coordinate with legal team and other stakeholders for finalization of agreements (e.g. CDA, CSA and vendor agreements). Assist study team in finalization of Feasibility Questionnaire and co-ordinate with site for completion and track collected information. Assist study team in site selection process and document collection. Prepare and compile documents for regulatory submission; as applicable. Coordinate and/or prepare dossiers for EC submission. Coordinate translations of study documents. Coordinate with investigators and sites for IM and assist PM in planning for IM, if applicable. Perform EC submission related activities including co-ordination with study team and other stakeholders. Prepare and dispatch SIV package to sites (including SMF). Prepare, maintain and update in a timely manner, the Trial Master File (TMF/eTMF) and the study folder as per SOP/study requirements. Co-ordinate with vendor(s) for contracted activities. Co-ordinate for procurement, calibration and tracking of Clinical trial supplies including in-house inventory management and ensuring that the sites have all the required supplies at initiation and during the study. Co-ordinate for study/team meetings and prepare minutes. Update and maintain study trackers & study systems (e.g. CTMS) for the assigned projects. Follow up with the study team members/sites/vendors for all the pending documents. Support PM for CRO related activities of outsourced studies. Coordinate with auditors and study team for audits, CAPA preparation and closure as assigned by FH/PM/LM. Initiate and track investigator, site and vendor payments. Co-ordinate for study document archival as applicable. Complete assigned trainings and maintain updated personal training file. Qualifications: Minimum Bachelor’s Degree in a science related field Proficient in Microsoft Office (Word, Excel, and PowerPoint) Excellent written and verbal communication skills #J-18808-Ljbffr

The Alaka`ina Foundation Family of Companies (FOCs) is looking for a qualified Clinical Trials Manager to support our government client in Silver Spring, Maryland . *This is not a remote position. The ideal candidate must be within reasonable commuting distance to provide onsite support.* DESCRIPTION OF RESPONSIBILITIES: Reports directly to the Program Manager. Manages all aspects of a clinical trial from pre-study to study close-out for entities such as drug companies, private physicians, academic institutions, and government agencies. Defines the trial budget and schedule. Reviews clinical research protocols for compliance, logistical support, and to ensure adequate staffing is available and scheduled appropriately. Oversees the screening and qualification of potential study subjects. Collects and reviews clinical data and ensures that all information needed to achieve the trial objective is obtained (i.e. review source documents, ensure data is entered correctly). Monitors progress of the trial and reports any issues to the trial director or physician. Trains, supervises, and tracks training requirements for trial staff and ensures that procedures are executed correctly. Reviews and updates all Standard Operating Procedures (SOPs) as required. Provides back-up coverage for any position to include but not limited to CRC, phlebotomist, recruiter, and administrative assistant. Provides and/or coordinates all contractually required reports. May be required to work evenings, weekends, and/or occasional nights. Typical work schedule is M-F 6:00AM - 2:30PM. Other duties as assigned by Supervisor. REQUIRED DEGREE/EDUCATION/CERTIFICATION: Registered Nurse with five (5) years of experience in Clinical Research. Maintain Certification in Clinical Research Coordination by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA). Basic Life Support (BLS -CPR/ AED) certification. REQUIRED SKILLS AND EXPERIENCE: Solid regulatory-affairs experience is required, preferably related to vaccine research (i.e - Phase I vaccine prep/mixing). Must be able to work independently following a brief period of specific technical training. Ability to establish and maintain effective working relationships with coworkers, managers, and customers. Knowledge of applicable highly complex scientific procedures and techniques relating to position. DESIRED SKILLS AND EXPERIENCE: Advanced Cardiac Life Support (ACLS) certification encouraged. REQUIRED CITIZENSHIP AND CLEARANCE: Must be a U.S. Citizen Must be able to pass a background check for a NACI. The Alaka`na Foundation Family of Companies (FOCs) is a fast-growing government service provider. Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 11 paid holidays. We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We are proud to state that we do not illegally discriminate in employment decisions on the basis of any protected categories. If you are a person with a disability and you need an accommodation during the application process, please click here to request accommodation. We E-Verify all employees "EOE, including Disability/Vets" OR "Equal Opportunity Employer, including Disability/Veterans" The Alaka ina Foundation Family of Companies (FOCs) is comprised of industry-recognized government service firms designated as Native Hawaiian Organization (NHO)-owned and 8(a) certified businesses. The Family of Companies (FOCs) includes Ke aki Technologies, Laulima Government Solutions, Kpono Government Services, and Kapili Services, Po okela Solutions, Kkaha Solutions, LLC, and Pololei Solutions, LLC. Alaka ina Foundation activities under the 501(c)3 principally benefit the youth of Hawaii through charitable efforts which includes providing innovative educational programs that combine leadership, science & technology, and environmental stewardship. For additional information, please visit #LI-JS1 #ClearanceJobs #J-18808-Ljbffr

About Our Client:
Our client is a leading global pharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that improve patient lives. They are at the forefront of medical research and committed to scientific excellence. They are seeking a meticulous and dedicated Research Associate specializing in Clinical Trials to join their cutting-edge R&D team in Chicago, Illinois, US . This role is crucial for supporting the conduct and management of clinical studies.

Job Summary:
The Research Associate, Clinical Trials, will provide essential support for the planning, execution, and monitoring of clinical trials across various therapeutic areas. This involves managing study documentation, coordinating with study sites, ensuring data integrity, and adhering to regulatory guidelines (GCP, ICH). The successful candidate will possess strong organizational skills, meticulous attention to detail, and a foundational understanding of clinical research processes, contributing directly to the advancement of new medical treatments and therapies.

Key Responsibilities:

• Assist in the preparation, review, and maintenance of essential study documents, including protocols, informed consent forms, case report forms (CRFs), and study manuals.
• Support the Clinical Research Coordinators (CRCs) and Clinical Research Associates (CRAs) in the day-to-day management of clinical trial sites.
• Coordinate with study sites for data collection, query resolution, and document submission.
• Ensure accuracy, completeness, and consistency of clinical trial data by performing data review and validation.
• Maintain electronic and paper trial master files (TMF/eTMF) in an organized and audit-ready manner.
• Track and manage study supplies, samples, and equipment.
• Assist in the preparation of regulatory submissions and ethics committee applications.
• Participate in site initiation visits, monitoring visits, and close-out visits as needed.
• Communicate effectively with study sites, investigators, and internal teams regarding study progress and issues.
• Assist with the reconciliation of clinical trial data and documentation discrepancies.
• Ensure all activities comply with Good Clinical Practice (GCP), ICH guidelines, and relevant regulatory requirements.
• Support the preparation of study reports, presentations, and publications.
• Identify and escalate potential issues or risks to study management promptly.
• Assist in the training of new site staff on study protocols and procedures.

Qualifications:

• Bachelor's degree in a life science, healthcare-related field, or a relevant scientific discipline.
• Minimum of 1-3 years of experience in clinical research, clinical trials, or a related healthcare/scientific environment.
• Familiarity with Good Clinical Practice (GCP) and ICH guidelines is highly preferred.
• Strong organizational skills and meticulous attention to detail in document management and data handling.
• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint); experience with clinical trial management systems (CTMS) or electronic data capture (EDC) systems is a plus.
• Excellent written and verbal communication skills.
• Ability to work independently and collaboratively in a team-oriented research environment.
• Strong problem-solving abilities and a proactive approach to task management.
• Ability to manage multiple tasks and prioritize effectively under deadlines.
• A genuine interest in scientific research and drug development.
• Relevant certifications (e.g., CCRP) are advantageous.

What We Offer:
Our client offers a competitive salary, comprehensive health, dental, and vision insurance, a robust 401(k) plan with company match, generous paid time off, and significant opportunities for professional development and career advancement within the pharmaceutical industry. You will be part of a highly collaborative and impactful R&D team, contributing directly to the development of life-changing therapies. Join an organization that values scientific rigor, innovation, and a commitment to patient well-being.

Application Process:
Interested candidates are invited to submit their resume and a cover letter detailing their clinical research experience and commitment to quality. Our client is an Equal Opportunity Employer, committed to fostering a diverse and inclusive scientific community.

• Assist in the screening, recruitment, and enrollment of study participants according to protocol criteria.
• Obtain informed consent from study participants, ensuring full understanding of the trial procedures.
• Collect and record study data accurately and completely in case report forms (CRFs) or electronic data capture (EDC) systems.
• Prepare and process biological samples (e.g., blood, urine) for laboratory analysis, ensuring proper handling and shipping.
• Schedule and coordinate participant visits, tests, and procedures as outlined in the study protocol.
• Maintain comprehensive and organized study files, including regulatory documents, source documents, and participant records.
• Ensure strict adherence to Good Clinical Practice (GCP) guidelines, HIPAA regulations, and all applicable regulatory requirements.
• Assist with the preparation for and participation in internal and external audits and inspections.
• Communicate effectively with study participants, addressing their questions and concerns.
• Collaborate with clinical investigators and study team members to ensure protocol compliance and resolve study-related issues.
• Assist in the review and verification of study data for accuracy and completeness.
• Order and manage study supplies and equipment.

• Bachelor's degree in a life science (e.g., Biology, Biochemistry, Nursing), Public Health, or a related field.
• Minimum of 1-3 years of experience in clinical research, preferably as a Research Associate, Clinical Research Coordinator, or similar role.
• Strong understanding of ICH-GCP guidelines and regulatory requirements for clinical trials.
• Experience with data collection, electronic data capture (EDC) systems, and maintaining accurate study documentation.
• Excellent organizational skills and meticulous attention to detail.
• Strong interpersonal and communication skills, with empathy for study participants.
• Ability to work independently and as part of a collaborative team in a fast-paced environment.
• Proficiency in Microsoft Office Suite.

• Clinical Research Coordinator (CRC) certification (e.g., ACRP, SoCRA).
• Experience with specific therapeutic areas (e.g., oncology, cardiology, neurology).
• Familiarity with laboratory procedures and sample processing.

The National Institute of Clinical Research, a leading research organization serving the pharmaceutical and biotechnology industries, is seeking a Clinical Trials Regulatory Specialist with 2 or more years of experience, to join our team.

We are looking for a skilled and motivated individual responsible for preparing, reviewing, and maintaining regulatory documents and submissions to ensure full compliance with FDA regulations, ICH-GCP guidelines, and sponsor requirements. This role plays a critical part in supporting clinical trial start-up, maintenance, and close-out activities, ensuring all required documentation is accurate, complete, and submitted in a timely manner.

Responsibilities include:

Prepare and submit regulatory documents (e.g., 1572s, CVs, financial disclosures, protocol submissions, IRB submissions, etc.) for clinical studies.

Track and maintain essential regulatory documents in accordance with sponsor and regulatory requirements.

Communicate with Institutional Review Boards (IRBs), sponsors, and internal departments to ensure regulatory compliance and timely approvals.

Maintain Trial Master File (TMF)/Investigator Site File (ISF) and ensure inspection-readiness.

Monitor study timelines and proactively manage submission deadlines and expirations.

Support study start-up and close-out activities by coordinating required documentation.

Assist with audits and inspections as needed.

Stay current with relevant regulations, guidelines, and industry best practices.

Qualifications:

Bachelor’s degree in Life Sciences, Healthcare, or related field preferred.

Minimum of 2 years of regulatory experience in a clinical research setting.

Knowledge of FDA regulations, ICH-GCP, and clinical research protocols.

Strong organizational skills and attention to detail.

Excellent written and verbal communication skills.

Proficiency with Microsoft Office Suite and electronic regulatory systems.

Preferred Skills:

Experience working with IRBs and regulatory agencies.

Familiarity with CTMS or electronic document management systems.

Clinical Research Coordinator (CRC) or Regulatory Affairs Certification (RAC) is a plus.

Candidates must be local to Orange County, CA area

Location

Garden Grove, CA

Full-time

This is not a remote position

Benefits

Medical Insurance, Dental & Vision Insurance, 401k, PTO