2,574 Clinical Trials jobs in the United States

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Job Description

CLINICAL OPERATIONS: Clinical Operations is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development Operations functions, ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead's products.

Key Responsibilities:

• In partnership with Clinical Program Manager or Associate Director, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines
• Communicates with functional peers regarding project status and issues and ensure project team goals are met
• Oversees operational aspects of assigned clinical trial(s) and oversees clinical trial conduct including study start-up, enrollment, maintenance and close-out.
• Prepares and/or contributes to development of study-related documents (e.g., Clinical protocols, Informed consent forms, Pharmacy Manual, Monitoring Plan, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans, Clinical Study Report
• Coordinates data review to support interim/final data analysis
• Participates in study strategy development.
• Maintains study timelines.
• Contributes to development of study budget.
• Contributes to development of RFPs and participate in selection of CROs/vendors.
• Provide guidance and training to CROs, vendors such as IWRS, Central lab, eCOA, recruitment vendors, investigators and study coordinators on study requirements
• Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management).
• Proactively identifies potential study issues/risks and recommends/implements solutions.
• Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings.
• May participates in the recruiting and hiring process for CTMs and supports their professional development
• May mentor other junior team members
• Coaches members of a work team and ensures adherence to established guidelines

• BS/BA degree in nursing, science or health related field with at least 5 years of trial management experience - OR -
• MS/MA degree in nursing, science or health related field with at least 3 years of trial management experience

• Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology
• Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management
• Highly developed leadership skills to successfully lead a clinical study team
• Ability to deal with time demands, incomplete information or unexpected events
• Must display strong analytical and problem solving skills
• Attention to detail
• Outstanding organizational skills with the ability to multi-task and prioritize
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities
• Complete knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, Good Clinical Practice (GCP) and key Clinical Operations principles, concepts, practices, standards, processes and tools.
• Familiar with standard medical / scientific terminology.
• Ability to communicate in a clear and concise manner.
• Ability to support a team-oriented, highly-matrixed environment.
• Ability to execute multiple tasks as assigned.
• When needed, ability to travel.

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

Job Description

Apply Here: &TrackId=ZipRecruiter

We are seeking multiple outgoing, patient focused individuals to work as Clinical Trials Research Assistant at our Retina Consultants of Minnesota Edina, MN clinic.

Responsibilities for an Clinical Trials Research Assistant include:

• Coordinate and schedule subject visits within study/subject specific windows per protocol guidelines.

• Prepare visit-specific documentation and charts for Clinical Research Coordinator

• Observe Coordinator in patient care and management

• Assist Coordinator in monitoring subject flow and assist in subject care and management

• Observe, assist, collect and record all necessary data for follow up (e.g. adverse events, concomitant medications, etc.) study visits (Phase 2 & 3; NO Gene Therapy)

• Transcribe subject study information from source documents to the Electronic Case Report Forms

• Administer all mandatory questionnaires to study subjects

• Set up, prepare subject, and conduct electrocardiograms (ECG) on subjects as required per study protocol

• Promptly request all necessary medical records for Serious Adverse Event Reporting

• Process and ship laboratory biological samples for analysis

• Perform intraocular pressure checks after injections

• Perform trial frame refraction and ETDRS visual acuity testing (For ISTs only, at selected sites)

• Inform subjects and obtain written re-consents in regard to ICF’s

Required Skills, Abilities and Attributes:

• Applicants MUST be personally motivated to provide excellent patient care!

• 1+ years of clinical trials research assistant experience in a retina or general ophthalmology environment preferred

• Knowledge of medical terminology

• Be an excellent team player who works cooperatively and respectfully with all doctors, supervisors and co-workers

• Displays a desire to perpetually “Learn and Grow”

• Efficient and highly accurate user of applicable information technology and health care management systems

• High School Degree or GED

We offer excellent compensation and benefits, to include:

• Paid Holidays - 7 days per year

• Personal Time Off (PTO) - 16 days per year

• Health Insurance

• Health Reimbursement Account

• Health Savings Account

• Dental Insurance (free single coverage)

• Flexible Spending Accounts

• Basic and Supplemental Term Life Insurance (free single coverage)

• Long Term Disability (free single coverage)

• Long Term Care (free single coverage)

• Short-Term Disability

• Vision

• Annual $250 uniform (scrubs and shoes) reimbursement

About Retina Consultants of Minnesota (RCM):

RCM has 9 Minnesota locations - St. Louis Park, Edina, Edina Specialty, Woodbury, Blaine, Duluth, Maplewood, Anoka and Mankato.

Everything we do…. every decision we make…takes our Guiding Principles into consideration. Our guiding principles are:

• We exist to serve our patients. We will provide the best available medical skills, technology, and service. We will be their advocates. We will care for our patients as if they were members of our family. We will treat our patients with respect, dignity, and kindness.

• We are proud of our dedicated staff. We will strive to provide a rewarding career with opportunity for personal and professional growth. We will promote teamwork. We will provide a respectful and safe working environment.

• We are humbled that other doctors entrust their patients to our care. We will be available when we are needed. We will promptly communicate the results of patient evaluation and treatment. We will respect the referring doctors’ relationships with their patients.

• We recognize that we have a responsibility to our community. We will strive to be desire to perpetually “Learn and Grow”

• Efficient and highly accurate user of applicable information technology and health care management systems

• A good corporate citizen. We will function ethically. We will be prudent in our stewardship of healthcare resources.

• Medical advances are critical to our patients. We will remain at the forefront in the search for new knowledge and treatments of retinal disease. We will participate in clinical research. We will share our knowledge with our patients and referring doctors, and with our retinal colleagues around the world.

Title: Director of Clinical Trials Location: Hybrid, Need to be local to Oakland, PA : 3 days a week onsite and 2 days remote Schedule: M-F 8 am-5 pm Type: Direct-Hire/Permanent Salary: 6-figures ! Start: April 2025 Overview: A top-ranked research university is currently searching for a DIRECTOR, OFFICE OF CLINICAL TRIALS. The director will work with the Clinical Research Leaders to oversee the clinical research mission's growth, management, oversight, and overall quality. This position ensures the success of its goals, maintains high-quality clinical research, and ensures effective management and resources of all activities, processes, and overall performance. Responsibilities Leads the development of strategic goals for the growth and development of the clinical research program in support of the overall vision and mission of our client. Oversees the implementation of these goals and actively monitors progress toward goals. Demonstrates expertise in Clinical Trials Management Systems (CTMS). Work collaboratively with peers in the development of the budget for the office and oversees the allocation of discretionary resources. Provides leadership or nominates and oversees the leadership of other clinical research related committees Promotes close interactions between clinical scientists in collaboration with Program Leaders, and administrative leadership. Effective at managing the Standard Operating Procedures/Standard Work Procedures for the office and research community. Help to establish metrics to ensure high quality work product and identifying opportunities for procedural improvement. Help to define policies, procedures, and training and documentation requirements to support effective, well communicated and timely process and policy changes. Requirements Bachelor’s degree in addition to a minimum of 10+ years of clinical research and/or related experience. At least 5 years in a leadership or supervisory role. Process improvement experience. MUST have worked and been a leader within a clinical trial office Excellent written and verbal communication skills are essential. Working knowledge of the Common Rule (45 CFR 46), the Privacy Rule (45 CFR 160, 164) and the regulations that govern human subjects research issued by the Food and Drug Administration (21 CFR 50, 56), and others as needed. Strong understanding of current standards for Good Clinical Practice (GCP) guidelines defined by the International Committee on Harmonization, FDA, NCI/NIH, OHRP, and the Office of Civil Rights, and according to state and institutional regulations. Able to apply broad technical, clinical/professional knowledge and significant job-related experience. Excellent writing capabilities, including the ability to write reports and business correspondence. Experience of legal language (contracts, confidentiality agreements, etc.). Expertise in financial (budgetary) source costing (NIH, Pharma, Foundation). The ability to analyze and prepare clinical study costing tools. Working knowledge of all types of clinical trial sponsors: federal grants and subawards, foundations, investigator initiated trials and industry funded. Preferred Qualifications: Master’s degree in business and healthcare administration or other related field Prior experience with design, roll out and implementation Clinical trial management systems Prior experience leading a team through period of reorganization or dramatic change. #M3 #LI-MD1 Ref: #558-Scientific

About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full-time employees after 30 days of employment, including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.Hourly Range: 20.00 - 22.00/hr (Depending on Experience) We have 2 shifts available (8:00 am to 4:30 pm, OR 8:30 am to 5:00 pm)Monday - Friday + must be able to work rotating weekends.Job Summary: With moderate oversight, the Pharmacy Technician I will assist in providing support of clinical investigational drug trials; provide accurate and efficient dispensing of medication, and perform cross-functional duties as required.Essential Responsibilities and Duties:Monitors pharmacy activities daily to ensure adherence to study protocols and dispensing procedures.Prepare and dispense investigational drugs in accordance with the IRB-approved protocols under the supervision of the Pharmacist or site management.Assist Pharmacist or site management in preparing blinded study products.Ensure the appropriate storage of investigational drugs according to the protocol and FDA guidelines.Monitor temperature of pharmacy storage areas and alert Pharmacist or site management of any temperature excursions of study drug.Assists in ordering, receiving, unpacking and storing pharmaceuticals and supplies.Rotates stock to ensure use before expiration date.Monitors expiration date and supply of drug for clinical trials.Prepares medication for dispensing to patients enrolled in inpatient study protocols.Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.Education/Experience/Skills:Must be able to effectively communicate verbally and in writing.Certified Pharmacy Technician required.Minimum of 1 year related experience preferred.Knowledge of basic pharmacy practices and procedures.Knowledge of medications and medical supplies.Ability to maintain quality control standards.Ability to react calmly and effectively in emergency situations.Ability to interpret, adapt, and apply guidelines and procedures.Attention to detail.Working Conditions Indoor, Clinic environment.Essential physical requirements include sitting, typing, standing, walking.Lightly active position, occasional lifting of up to 20 pounds.Reporting to work, as scheduled, is essential.On-site work arrangement.CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

The Department of Oncology at the Dell Medical School is looking for a Clinical Trials Administrative Associate. This is a temporary 9 month position, renewable based upon availability of funding, work performance, and progress toward goals.

Assist with administrative tasks in the clinical research department. This position works with the Department of Oncology faculty and staff to facilitate and coordinate administrative, clinical, and financial aspects of multiple research projects. This position requires data entry, file management, document organization, gathering of essential documents, and optimizing feasibility assessments.

Responsibilities:

• Work independently to obtain, abstract, and code complex clinical information from multiple sources (medical records, research records, etc.) for research subjects. Code and record information into study-specific data-capture systems (both electronic and paper-based). Resolve and answer data queries with minimal errors. Make independent judgments about the relevance of the clinical data to the research for complicated oncology research subjects. Create and maintain patient shadow charts (paper and eCharts).
• Enter completed patient visits, protocol deviations and additional data points into Clinical Trials Management System. Collaborate with members of Clinical Research Program team to ensure data entry is up to date and accurately reflects activities relating to research. Request medical records and archival tumor tissue when required from outside medical facilities. Independently develop study-specific or program data acquisition forms. Work professionally with research staff to review and correct data recorded in the case report forms. Exercise independent judgment on query resolutions.
• Principally responsible for maintaining computer spreadsheets and databases for research studies. Understanding research study flow, work with clinic staff support services and research team members. Collate and maintain clinical information from multiple sources into research charts, eCharts, study binders, etc. Help track and maintain research subject schedules based on complex protocol-specific requirements.
• Departmental newsletter creation and distribution, SOP maintenance, and update logs.
• Assist Clinical Research team with tracking laboratory sample supplies, completing requisition forms, and assembling kits for upcoming research subject visits for assigned clinical trials. Assist Clinical Research team with tracking and processing research subject samples following study specific guidelines for storage and/or shipping.
• Other related duties as assigned.

Bachelor's degree in a related field and 1 year of administrative level experience or high school/GED and 5 years of clerical experience. Relevant experience in the medical field. Demonstrated understanding of medical terminology. Strong computer skills, attention to detail and ability to organize work. Ability to communicate effectively both verbally and in writing, and to work effectively with colleagues, research subjects, and study sponsor representatives. Ability to work independently and to carry out complex tasks. Relevant education and experience may be substituted as appropriate.

More than two years of relevant experience in the medical field. Experience with data entry and databases. Knowledge of Oncology practice and terminology. Prior experience in billing compliance. Prior experience in basic processing and shipping of laboratory samples. Competency in Microsoft Office software. Knowledge of HIPAA regulations. Knowledge of Good Clinical Practice.

$32,000+ depending on qualifications

• May work around standard office conditions.
• Repetitive use of a keyboard at a workstation.

• Resume/CV
• 3 work references with their contact information; at least one reference should be from a supervisor
• Letter of interest

Important for applicants who are NOT current university employees or contingent workers: You will be prompted to submit your resume the first time you apply, then you will be provided an option to upload a new Resume for subsequent applications. Any additional Required Materials (letter of interest, references, etc.) will be uploaded in the Application Questions section; you will be able to multi-select additional files. Before submitting your online job application, ensure that ALL Required Materials have been uploaded. Once your job application has been submitted, you cannot make changes.

Important for Current university employees and contingent workers: As a current university employee or contingent worker, you MUST apply within Workday by searching for Find UT Jobs. If you are a current University employee, log-in to Workday, navigate to your Worker Profile, click the Career link in the left hand navigation menu and then update the sections in your Professional Profile before you apply. This information will be pulled in to your application. The application is one page and you will be prompted to upload your resume. In addition, you must respond to the application questions presented to upload any additional Required Materials (letter of interest, references, etc.) that were noted above.

Employment Eligibility: Regular staff who have been employed in their current position for the last six continuous months are eligible for openings being recruited for through University-Wide or Open Recruiting, to include both promotional opportunities and lateral transfers. Staff who are promotion/transfer eligible may apply for positions without supervisor approval.

Retirement Plan Eligibility: The retirement plan for this position is Teacher Retirement System of Texas (TRS), subject to the position being at least 20 hours per week and at least 135 days in length.

Background Checks: A criminal history background check will be required for finalist(s) under consideration for this position.

Equal Opportunity Employer: The University of Texas at Austin, as an equal opportunity/affirmative action employer, complies with all applicable federal and state laws regarding nondiscrimination and affirmative action. The University is committed to a policy of equal opportunity for all persons and does not discriminate on the basis of race, color, national origin, age, marital status, sex, sexual orientation, gender identity, gender expression, disability, religion, or veteran status in employment, educational programs and activities, and admissions.

Pay Transparency: The University of Texas at Austin will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

Employment Eligibility Verification: If hired, you will be required to complete the federal Employment Eligibility Verification I-9 form. You will be required to present acceptable and original documents to prove your identity and authorization to work in the United States. Documents need to be presented no later than the third day of employment. Failure to do so will result in loss of employment at the university.

E-Verify: The University of Texas at Austin use E-Verify to check the work authorization of all new hires effective May 2015. The university's company ID number for purposes of E-Verify is . For more information about E-Verify, please see the following:

• E-Verify Poster (English) (PDF)
• E-Verify Poster (Spanish) (PDF)
• Right To Work Poster (English) (PDF)
• Right To Work Poster (Spanish) (PDF)

Compliance: Employees may be required to report violations of law under Title IX and the Jeanne Clery Disclosure of Campus Security Policy and Crime Statistics Act (Clery Act). If this position is identified a Campus Security Authority (Clery Act), you will be notified and provided resources for reporting. Responsible employees under Title IX are defined and outlined in HOP-3031. The Clery Act requires all prospective employees be notified of the availability of the Annual Security and Fire Safety report. You may access the most recent report here or obtain a copy at University Compliance Services, 1616 Guadalupe Street, UTA 2.206, Austin, Texas 78701.