Clinical Trials Assistant Job Description
Clinical trials assistant
provides nursing care and oversight of clinical trial subjects while complying with Good Clinical Practice, regulatory and protocol requirements.
Clinical Trials Assistant Duties & Responsibilities
To write an effective clinical trials assistant job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical trials assistant job description templates that you can modify and use.
Sample responsibilities for this position include:
A general knowledge of applicable clinical research regulatory requirements
Planing and conducting Therapeutic Area meetings
Organizing and setting content for meetings
Consolidating, creating and distributing agendas
Coordinating, loading, distributing and consolidating meeting review materials
Creating, distributing, and tracking meeting outcome with follow-up actions via meeting minutes
Assisting the Therapeutic Area Head in aligning/ensuring consistent processes applied across Therapeutic Area and Franchise
Helping to identify resource, scientific, operational and learnings gaps within the Therapeutic Area
Supporting the educational mission of the Therapeutic Area
Support OTM LCTL and CTLs in ensuring all trial deliverables are met according to timelines, budget, operational procedures and quality standards
Clinical Trials Assistant Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Clinical Trials Assistant
List any licenses or certifications required by the position: NCCPA, ACLS, BLS, MA, CCRC, CA, IV
Education for Clinical Trials Assistant
Typically a job would require a certain level of education.
Employers hiring for the clinical trials assistant job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Business/Administration, Biostatistics, Management, Health Care Administration, Education, Nursing, Healthcare, Science, Pharmacy, Public Health
Skills for Clinical Trials Assistant
Desired skills for clinical trials assistant include:
Applicable protocol requirements as provided in company training
Excel and PowerPoint
Microsoft Word
Applicable clinical research regulatory requirements
Good Clinical Practice guidelines
Applicable protocol requirements
Good Clinical
Good Clinical Practice guidelines as provided in company training
Biotech/pharmaceutical/healthcare industry
Good Clinical Practice and
Desired experience for clinical trials assistant includes:
Develop specific sections of related study documents
Develop study tools, guidelines, and training materials
Manage clinical study material
Implement and issue resolution plans
Support CTLs by setting up and maintaining appropriate study tracking forms
Support the CTLs in drafting the ICF global template
Clinical Trials Assistant Examples
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Clinical Trials Assistant Job Description
Job Description Example
Our innovative and growing company is looking for a clinical trials assistant. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for clinical trials assistant
- Contribute to, and participate in, study dry runs, pre-study planning activities, departmental and project specific meetings
- Prepare and send CDAs, and other study related materials to clinical study sites
- Coordinate in-house blood draws and internal sample collection studies
- Participate in the development andrevision of documents and study support materials
- Track progress of projects and identify appropriate actions to achievetarget objectives
- Reviewdocuments for completeness and accuracy
- Maintain relationship with sponsors andstudy sites throughout trials
- Implement the standards for research protocols in compliance with regulatory, institutional and external agencies
- Clinical responsibilities include monitoring toxicities, assessing clinical responses and providing exemplary patient care while ensuring the protocol is conducted in a high quality manner
- Offer patient education and patient/family support
Qualifications for clinical trials assistant
- High or Secondary School diploma/certificate or country’s educational equivalent and 3 years administrative support experience
- Good written and verbal communication skills including good command of German and English language
- Bachelor’s degree in life science or related field and 3-4 years clinical research experience, or equivalent combination of education, training and experience
- Bachelor/Master in life science related study program or country’s educational equivalent and administrative support experience
- School diploma/certificate or educational equivalent
- Minimum 1 year of clinical monitoring experience in the pharmaceutical / CRO industry
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Clinical Trials Assistant Job Description
Job Description Example
Our company is growing rapidly and is looking for a clinical trials assistant. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical trials assistant
- Collaborate with Clinical Project Manager (CPM), CRS/iCRS, CRAs/iCRAs and RSU on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures
- May perform assigned administrative duties to support team members with clinical trial execution
- Collaborate with Clinical Project Manager (CPM), CRAs/iCRAs and RSU on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures
- Assist with periodic review of study files and completeness
- Hire, supervise, coach, mentor, and manage performance of the supervisory staff in the office and provide oversight of the staff who report to them
- Establish and maintain an organizational structure that optimally supports the conduct and support of clinical trials in the Center
- Support the UACC Director and Associate Director of Administration in driving unifying clinical development strategies across the two campuses, Tucson and Phoenix
- Support the Deputy Director of the UACC in the running of the UACC-Phoenix, including hiring, grants, space, and clinical trials
- Develop and maintain Clinical Trials Office policies, procedures, work instructions, and other resource information that allows the staff to perform efficiently and to deliver a high quality work product
- Oversee multiple areas within the UACC-Phoenix Clinical Trials Office, accountable for ensuring excellence and compliance in areas of human resources, clinical trials, grants/contracts management, public relations/communications, philanthropy, and facility management
Qualifications for clinical trials assistant
- You may accompany Clinical Research Associates on site visits to assist with clinical monitoring duties upon completion of required training and with required approval
- Please only add information if it is applicable to the vacant job
- Clinical research nursing experience preferred
- Bachelor’s degree or equivalent in the life sciences or related field required
- Related research experience strongly preferred
- Clinical documents
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Clinical Trials Assistant Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of clinical trials assistant. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical trials assistant
- Organize academic conferences that focus on disease or research dependent topics
- Work closely with the UACC-Tucson Operations to synergize clinical trials efforts across the two UACC campuses
- Develop, implement, and maintain effective staff training programs
- Develop and implement metrics for productivity and quality
- Provide input to the development of annual budgets for the clinical trials operation, monitor financial status, and take appropriate actions required to manage to budget
- Serve as a liaison to college and university offices, state and federal agencies, affiliated programs and industry sponsors related to the conduct of clinical research
- Develop and maintain strong working relationships with clinic management and staff members who provide standard care in outpatient clinic(s)
- Provide information in support of the NCI Cancer Center Support Grant, progress reports, renewal applications, other grant applications, and contract proposals
- Maintain a high level of knowledge regarding clinical research protocol development and conduct, budgeting, and contracts in order to serve as a resource for the staff and investigators
- Provide oversight of regulatory compliance and monitoring
Qualifications for clinical trials assistant
- You can work independently, follow written instructions and able to work with a remote team
- Must be a University Student
- Ability to perform standard clinical laboratory tests, procedures and analyses accurately and with skill
- Knowledge of clinical protocols, procedures, and practices in specialty area
- Knowledge of Institutional Review Board (IRB), Biosafety and General Clinical Research Center (GCRC) applications
- Knowledge of proper safety precautions and procedures utilized in handling all types of laboratory specimens, reagents, chemicals and hazardous waste
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Clinical Trials Assistant Job Description
Job Description Example
Our innovative and growing company is looking for a clinical trials assistant. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for clinical trials assistant
- Report on activities of program to UACC administration, NCI, or others
- Work with the communications group to develop internal and external communications to develop positive and informative messaging for the UACC-Phoenix
- Support the UACC Director, Deputy Director, and Associate Director of Administration in driving unifying clinical development strategies across the two campuses, Tucson and Phoenix
- Support the Deputy Director and Medical Director of the UACC-Phoenix in the day-to-day administrative operations of the UACC-Phoenix, including hiring, grants, space, and clinical trials
- Develop and maintain Clinical Trials Office and other administrative policies, procedures, work instructions, training programs, and other resource information that allows the staff to perform efficiently and to deliver a high quality work product
- A High or Secondary School diploma/certificate or country’s educational equivalent (MBO/HBO)
- Develop and manage of a research matrix to monitor the progress of all Clinical Trials within the Division of Cardiology
- Assess feasibility and ongoing monitoring of clinical trial workload across the Division of Cardiology with the Division’s Clinical Director of Research
- Assist the Clinical Trials Finance Manager for budget development for upcoming clinical trials
- Provide ongoing support for other research coordinators regarding UC Denver’s research processes and study-specific procedures
Qualifications for clinical trials assistant
- Knowledge of research techniques
- Knowledge of use and care of laboratory equipment, instruments, and supplies
- Should be a University Student
- Bachelor's degree or equivalent with at least less than 1 year experience in administration
- Experience handling biological samples (blood and urine specimens)
- Experience executing protocol-required tasks
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Clinical Trials Assistant Job Description
Job Description Example
Our company is searching for experienced candidates for the position of clinical trials assistant. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical trials assistant
- Supervision, training and mentoring of PRAs, serving as clinical trial coordinators, in day to day processes and query resolutions
- Evaluate study assignments and assess work load
- Conduct periodic audits of all the study documentation to ensure compliance and completeness
- Work directly with industry sponsor monitors to ensure completeness of all work submitted
- Troubleshoot database resolution
- Monitor and track data entry, subject screening and enrollment activities, and troubleshoot areas where needed for compliance
- Develop and submit accurate IRB applications, Continuing Review Reports and all other required documents to support the conduct of clinical trials research
- Formulate consent documents in accordance with IRB regulations and sponsor-specific requests
- Assist with the drafting of protocols, case report forms, and other required documents for Investigator Initiated trials
- Provide direction and support for subject recruitment, tracking of study visit schedule appointments
Qualifications for clinical trials assistant
- Knowledge of quality assurance methods and procedures as applicable
- Knowledge of cardiology patient populations and ability to perform telephone screenings
- Ability to elicit clinically significant information from patients/subjects
- Demonstrated ability to perform lab duties safely and ship laboratory specimens on time
- Ability to prepare IRB forms
- Bachelor’s degree in a related field (Business Administration, Nursing, Healthcare Administration, Clinical Research Management, ) and at least 5 (five) years of work experience in a clinical research setting