Clinical Research Training Specialist Jobs

Advanced organizational and project management abilities, including the ability to work within tight deadlines on a range of projects.

Identifies knowledge gaps to improve efficiency and reduce time to proficiency.

Bachelor’s degree or equivalent experience is required.

Demonstrated leadership skills, including strong communication, presentation, written and interpersonal skills.

Basic non-investigator clinical skills related to site research roles required.

Strong analytical and decision-making capabilities that support clinical improvement initiatives.

Previous study coordination and/or project management experience in clinical research

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

Knowledge of regulatory requirements and guidelines for facilitating clinical human subjects research, including Health and Human Services (HHS) regulations

Serves as the point-of-contact and project manager for an assigned portfolio of projects

This position is located in Rockville, Maryland. Remote work is possible.

Strong collaborative skills with ability to build relationships within multiple groups

Reports adverse events and near misses to appropriate management authority.

Skill in statistical programming, interpretation and data analysis using statistical software as well as spreadsheet and database software applications.

Ability to apply knowledge of scientific theory and computer capability to design and recommend changes to methods for clinical research.

Knowledge of best practice in Clinical Research.

Recruit and screen subjects for research studies.

Perform administrative duties such as providing training and guidance to other clinical research staff.

May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts.

Participates in required training and education programs.

Provides clinical research expertise by participating in the design and implementation of research projects as needed by the department or institution.

Responsible for specific and assigned aspects of research infrastructure development and/or maintenance.

Coordinates research projects at an institutional or departmental level.

Communicates project status and improvement areas with leadership in a timely manner.

Update job knowledge by participating in educational opportunities; reading professional publications, maintaining personal networks, and participating in professional organizations.

Work closely with the clinical experience team to help identify and escalate issues to the appropriate team.

High school diploma or equivalent with on-the-job training; associate degree; and clinical orthodontic experience.

5 years of experience performing all functions in an orthodontic office.

Experience successfully conducting group trainings to introduce new products or orthodontic protocols.

Familiar with Salesforce, MS Office suite; and proficient computer skills with the ability to use different treatment software and web tools.

Follows patients on study and maintains knowledge of adverse events

Collaborates with physicians, mid-level practitioners, research nurse and data managers to document patient care

Coordinates reports for the study manager for submitting grant data in a timely manner

Provides study related coordination including protocol maintenance

Develops and maintains a processing and tracking system for all protocol related documents

Develops patient care methodology for protocols, including criteria for patient participation

Required Knowledge, Skills and Abilities:

Assist with customer complaint-handling and management, as applicable.

Significant clinical experience including planning of cataract surgery, refractions/biometry and associated device operations.

Strong knowledge of the cataract patient diagnostic and evaluative process at the clinic level, including patient flow.

Strong understanding and OR experience related to Cataract Surgery.

Proven and excellent communication skills, written and verbal.

2+ years of experience of administrative, contract management or paralegal experience is required.

Collaborate with Finance and key operational team members to incorporate project status into projections.

CRO or site network experience

Prior experience work with clinical research site budgets.

Prior Paralegal or negotiation of contract language experience.

Basic knowledge of medical terminology and a working knowledge of drug development services desired.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

·Manage Investigator-Initiated clinical research studies.

·Lead required cross-functional research meetings to discuss studies and get input from product managers.

·Manage data collection compliance via tracked milestones.

·Responsible for the execution of clinical projects while adhering to budget, scope and schedule requirements.

•4 years of relevant clinical research experience required

Experience/Knowledge of IR/CT Suite, Operating Room Protocol and Sterile Technique.

Five or more years of work related medical industry (service or technology) or clinical experience

Must be able to pass background and motor vehicle checks and maintain Company standards regarding each of these requirements.

Excellent sales and communications’ skills (internally and externally).

Excellent written and verbal communication skills.

Detail oriented with excellent organizational skills.

§ Create the protocol schedule of events/calendar within the Clinical Trial Management system.

§ Transcribe existing negotiated budgets into the Clinical Trial Management system.

§ Cross-reference the budget with the contract, payment terms, coverage analysis and informed consent to ensure consistency.

§ Set up financial and operational data of clinical studies in the CTMS

§ Other miscellaneous duties as needed.

Additional duties may be assigned by manager as needed

3+ years of experience in the hospital and/or healthcare industry

Experience in Cardiology and/or Respiratory Therapy an asset

Great interpersonal skills, attention to detail and strong organizational skills required

Excellent communication skills - written and verbal

Knowledge of Cardio Server software an asset

Experience/Knowledge of IR/CT Suite, Operating Room Protocol and Sterile Technique.

Five or more years of work related medical industry (service or technology) or clinical experience

Must be able to pass background and motor vehicle checks and maintain Company standards regarding each of these requirements.

Excellent sales and communications’ skills (internally and externally).

Excellent written and verbal communication skills.

Detail oriented with excellent organizational skills.

Equipment and Computer Software Skills and Abilities:

Gather feedback from trainers and trainees after each educational session

Training Coordinators should have at least 3 years of work experience.

Previous work experience as a Training Coordinator, Training Facilitator, Trainer or a similar role in a corporate environment is preferred.

Bachelor’s degree in healthcare administration, business administration preferred or equivalent experience.

General Duties/Responsibilities (May Include But Are Not Limited To)

Reports adverse events and near misses to appropriate management authority.

Skill in statistical programming, interpretation and data analysis using statistical software as well as spreadsheet and database software applications.

Ability to apply knowledge of scientific theory and computer capability to design and recommend changes to methods for clinical research.

Knowledge of best practice in Clinical Research.

Recruit and screen subjects for research studies.

Perform administrative duties such as providing training and guidance to other clinical research staff.

Maintains all DSMC required documentation and ensures accurate recording of DSMC reviews into the clinical trial management system (OnCore).

Works with CCTO management to establish and optimize metric reports.

Assists in management of SOCCI Protocol Review and Management Committee by serving as a backup when necessary.

Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs.

3 years of related experience in a similar position is required.

Prior monitoring or auditing experience in clinical research preferred.

Prepares and negotiates study and vendor contracts, as well as awards clinical research studies within the contract management system.

License or Certification required by statute or regulation

License or Certification required by the Department

Liaises and establishes effective relationships with sponsors, study teams, and ancillary stakeholders.

Ensures alignment of contract consultation process for teams and study are properly aligned to the critical path for site activation

Prepares and reviews budgets, templates and supporting documents.

Skill in completing assignments accurately and with attention to detail.

Ability to analyze, organize and prioritize work under pressure while meeting deadlines.

Ability to process and handle confidential information with discretion.

Ability to work evenings, nights, and weekends as necessary.

Commitment to the University’s core values.

Ability to work independently and/or in a collaborative environment

Knowledge of Federal and State regulatory issues/mandates concerning Institutional Review Board requirements

This position has potential to work remotely (must live in California).

Two years’ experience with Word, Excel and Internet access/use

Previous experience with clinical research

BS/BA degree in health sciences or related field

Formal training in decision support, databases, spreadsheet, report writer, query/relational database computer software applications