Associate Clinical Job Description
Associate clinical
provides oversight and project management of clinical studies at Avanir, including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Avanir SOPs.
Associate Clinical Duties & Responsibilities
To write an effective associate clinical job description, begin by listing detailed duties, responsibilities and expectations. We have included associate clinical job description templates that you can modify and use.
Sample responsibilities for this position include:
Monitor supply progress, communicate supply projections and timelines and raise awareness to potential issues
Create and develop label text in conjunction with clinical operations, regulatory and QA for all clinical supplies
Facilitate the review and approval of the clinical label and label proofs
Ensure all documentation is prepared and approved for the clinical packaging and labeling production runs
Schedule packaging and labeling runs with CMO to ensure timely delivery of the clinical products
Work with QA/QP to ensure timely release of the packaged and labeled clinical products
Monitor clinical study distribution inventory levels and plan and execute distribution requirements to ensure inventory levels are kept up to determined levels
Work with IVRS systems and monitor the site and depot inventory levels and settings
Manage IMP return drug management activities in coordination with sites and clinical operations
Prepare weekly and monthly reports of inventory and shipment for active protocols as needed
Associate Clinical Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Associate Clinical
List any licenses or certifications required by the position: BLS, CRA, SCDM, CCRP, CPR, CCRC, SOCRA, S8, COA, GCP
Education for Associate Clinical
Typically a job would require a certain level of education.
Employers hiring for the associate clinical job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Education, Science, Associates, Health, Medical, Nursing, Healthcare, Pharmacy, Life Science, Technical
Skills for Associate Clinical
Desired skills for associate clinical include:
FDA
Clinical research
GCP
ICH Guidelines
Statistics
EMA Regulations
GCP governing the conduct of clinical studies
Current GCP/ICH & country clinical research law & guidelines
Good Documentation Practices
Phases of clinical trials
Desired experience for associate clinical includes:
1+ years of experience within the biotechnology or pharmaceutical industry
MS in Pharmacology, Biology, Pharmaceutics, or any of the clinical sciences
3+ years of industrial experience in conducting clinical trials
Planning and execution of in-house or outsourced clinical trials
Assisting in the supporting the conduct of trials and managing specific study and operational tasks
Performing work within established protocols under general supervision
Associate Clinical Examples
1
Associate Clinical Job Description
Job Description Example
Our growing company is looking to fill the role of associate clinical. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for associate clinical
- Provide professional clinical support to new and existing customers (primarily physicians) on our three-dimensional mapping system, Carto 3 inclusive of electro-anatomical mapping
- Responsible for tracking study budgets, including invoice and PO management/reconciliation, month end actuals and accruals in support of the CTM and Finance
- Reviews clinical trial documentation including monitoring visit reports, study plans, communication plans, timelines, informed consent templates
- Responsible for set-up, maintenance, reconciliation, and archiving of electronic Trial Master Files
- Assists and/or participates in planning and conduct of Investigator’s Meetings as necessary
- Perform contract management tasks on low to medium complexity projects, as assigned.*
- Develop, review and negotiate Confidentiality Agreements, Letters of Intent, Services/Consulting Agreements, Clinical Development Agreements, Master Services Agreements (including multi-unit MSAs), and Individual Project Agreements*
- Lead negotiations for all assigned Agreements with moderate management support*
- Lead the identification, development and negotiation of Change Orders for assigned projects with moderate management support*
- Assist/mentor junior staff including providing pre-submission review and approval of junior staff’s signature documents in accordance with the Contract Management review guidelines, as assigned
Qualifications for associate clinical
- Identify, analyze problems and trends
- A minimum of 4 years experience from similar work within a pharmaceutical company or CRO is preferable, but can also have experience as a research coordinator
- College degree or equivalent experience in Clinical, Laboratory or Imaging Operations or similar
- Previous experience with clinical trials
- Has ability to understand the disease under study and the aim of the therapy
- Works well in multi-tasking team environment
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Associate Clinical Job Description
Job Description Example
Our growing company is looking for an associate clinical. 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 associate clinical
- Perform accurate maintenance of CMS
- Provide accurate updates on all outstanding contractual documents to Management on a weekly basis or as otherwise required
- Screen patients for enrollment
- Lead or supports short, dedicated projects focused on key value drivers or market opportunities, applying a consultative, hypothesis-driven approach (e.g., a “deep dive”)
- Work with clinical and operations leaders and executive leaders to scope pilot projects, develop metrics to measure pilot success, and facilitate and scale pilot projects quickly
- Research and analyze opportunities for care redesign projects or new clinical products and coordinate with clinical leaders and operators in a consultative fashion on design and execution
- Analyze clinical program performance metrics to identify insights and strategic recommendations to improve existing clinical programs and improve operations
- Contribute to long-term strategies for growth, including innovation within our services model and new product development to enhance the impact of our clinical services
- Coordinate with clinical stakeholders on quality improvement, process improvement, or innovation projects, as needed
- Perform other duties as assigned by the Chief Clinical Officer or supervisor
Qualifications for associate clinical
- At least 2 years of relevant experience in the biotechnology/pharmaceutical industry, with 1 year minimum in clinical document management
- Proficient in Microsoft Office Applications, such as Word, Excel, Access, PowerPoint
- Decide the technology platform (system/database) for data acquisition and aggregation
- Clinical knowledge and an ability to liaise effectively with study team members
- Technical knowledge to develop requirements and/or study/project deliverables
- 1-3 year's experience in similar/relevant field (eg.Sponsor, CRO, Clincal trial Vendor, Clincal Coordinator)
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Associate Clinical Job Description
Job Description Example
Our company is hiring for an associate clinical. 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 associate clinical
- Communicates appropriately with HCP’s and Sensor Sales Specialist Team
- Develops and provides education materials for HCP’s and Sensor Sales Specialist Team
- Implements proper protocols for HCP’s and Sensor Sales Specialist Team
- Comfortable training HCP’s over webinar
- Address requests in a timely and efficient manner
- May assist in the development and delivery of training materials providing subject matter expertise and know how
- Ensures all required student documentation is kept current
- Attends classroom meetings to explain and/or distribute pertinent materials to students as necessary as a follow-up to orientation
- Prepares letters, memos and other forms of communication to outside constituencies
- Works directly with central functions to maintain accurate clinical site requirements in order for students to attend
Qualifications for associate clinical
- Assure study site management
- Responsible for the development and maintenance of the overall budget for the clinical department, including all phase I-IV studies
- Serve as liaison between Clinical Operations and Pacira’s Legal and Accounting departments in coordinating the set-up, review, and approval of clinical trial agreements, consulting agreements, master service agreements, and work orders, tracking and reporting the expenses against the budget
- Assist as needed with the general work of keeping up with clinical functions as they intersect with other functional areas
- Assist in managing the day-to-day operational activities by participating in the decision making process within the Clinical Operations Department
- Track and provide updates on all clinical activities, including, but not limited to, site selection, initiation and monitoring, contract negotiations, subject enrollment, drug shipments, compliance
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Associate Clinical Job Description
Job Description Example
Our company is growing rapidly and is looking for an associate clinical. 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 associate clinical
- Works directly with clinical education faculty to ensure successful student clinical experiences
- Maintains accurate student and site information in placement database
- Develops and maintains effective working relationships with clinical site personnel to facilitate student placement
- Communicates, coordinates and confirms with clinical sites to determine internship availability and placement for students
- Maintains accurate and confidential student clinical education files in accordance with University, FERPA and HIPAA requirements
- Responds to site affiliate inquiries and questions
- Attends student orientation and open house each trimester to ensure student compliance for clinical site
- Maintains databases such as Constant Contact as needed for all programs
- Creates and delivers reports as requested by faculty for the purpose of student placement
- Assist the VP of Clinical Operations in the creation and maintenance of internal policies and SOPs policies intended to assist researchers in maintaining compliance with research standards and guidelines
Qualifications for associate clinical
- Responsible for oversight of vendors/consultants, which includes communicating timelines, negotiating contracts, preparing purchase requisitions, and coordinating related activities
- Assist in the planning and set up of Advisory Board meetings, ensuring the appropriate contracts are in place per company policy, as needed
- Assist in the management and archiving of department paper and electronic files for flexibility and growth
- Assist in coordinating the scanning, indexing, and releasing of clinical documents
- Work with the finance group to develop tools and align on process, trackers, and timelines relating to activities that interface with company financials
- Assist in the day-to-day operational activities and other specific projects as assigned within the Clinical Department
5
Associate Clinical Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of associate clinical. 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 associate clinical
- Apply and adhere to ICH/ GCP, biobanking policies, biosample management best practices, and ethical guidelines
- Development of a comprehensive, territory-specific business plan which includes strategies and tactics aimed at achieving annual sales goals set by management
- Support the development and use of Key Opinion Leaders from targeted accounts
- Consistently targets, develops, maintains and sells to existing customers and accounts
- Cross Collaboration with various internal and external departments(, HUB, RMD etc)
- Develop strong relationships by understanding each customer’s needs, goals, prescribing habits and competitive product standing
- Manage sales efforts within assigned promotional and operational budgets
- Submit accurate and timely expense reports, maintains accounts records and submits timely and thorough account and territory reports
- Successfully complete all required company training
- Coordinates and leads cross-functional teams, such as the clinical sub-teams that include representatives from multiple internal departments (eg, Medical Science, Regulatory Affairs, Data Management)
Qualifications for associate clinical
- 3+ years’ of health sciences experience is required (pharmaceutical industry or related experience is preferred
- Knowledge of the pharmaceutical business and ability to anticipate environmental changes and trends and implement changes accordingly
- Experiences that demonstrates strong attention to detail, excellent problem solving skills, the ability to effectively organize and manage multiple assignments with challenging deadlines, logical thought and an understanding of database structures
- Maintains strict confidentiality of patient records, protocols, and study blinding
- Initiate medication and protocol supply ordering for clinical study site(s) according to the sponsor directions
- Attends protocol educational meetings, which may require national and/or international travel