Lead Clinical Trial Associate
Job Snapshot
Full-Time Experience - 3 to 10 years
Degree – Associates or LPN; or mixture of education and experience as a CMA/RMA
POSITION SUMMARY
The Lead Clinical Trial Assistant (CTA) in collaboration with the Clinical Trial Manager, contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/WPs. Responsibilities may include participation on one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams and vendors.
The best Clinical Research Coordinator for this position will have experience and expertise in managing all aspects of a study and ideally experience and skill in managing people. Job duties include: conducting patient visits, coordinating studies, patient recruitment and prescreening, EDC data entry, IRB communications and regulatory documents, and sponsor / CRO communications. We are looking for a dedicated professional who truly enjoys the role of a CRC and who authentically cares about and focuses on the patient during study visits
Responsibilities and Duties:
- Provide operational input on development, management and maintenance of study deliverables [i.e. timelines, study plans, documents, etc.] through collaboration with internal and external stakeholders
- Use performance metrics and quality indicators to assist the clinical trial manager in driving study execution
- Lead / Participate in monitoring visit report review process in order to maintain oversight of clinical monitoring quality and adherence to protocol and established processes and plans
- Ensure full compliance (completeness & accuracy) of the required data in study management tools including CTMS, patient enrollment forecasting, etc.
- Proactive identification of potential risks and development/implementation of actions to avoid or mitigate
- Develop and maintain collaborative relationships with internal and external partners/stakeholders * Collaborate with vendors and other internal stakeholders regarding study specific issues and follow through to resolution
- Actively contribute to study meetings including: presentation, subject matter expert, generate, finalize and distribute study team agendas and meeting minutes, etc.
- Contribute to development / coordination of study training for study team, investigational sites, and vendors
- Assist with the collection of various study documents such as site insurance, CSR appendices, etc.
- Contribute to ordering and distribution of materials as required
- Support the development/coordination of study training materials for study team, investigational sites, and vendors in conjunction with study manager
- Manage collection, review and tracking of study documents as necessary
- Monitor contents of electronic trial master files and other electronic document systems maintained by CROs and transfer local working copies as needed to support client activities.
- Assist with Internal study team meetings, as needed: prepare and distribute study team agendas and minutes, present information as requested.
- Review study documentation, forms, manuals, etc. from CROs, ensure distribution and track review and response to CRO personnel as needed, and create summary reports for clinical projects/programs, as requested.
- Perform literature searches/reviews as necessary to gather background information for development of documents, training materials.
- Maintain awareness of developments in clinical research by reading relevant literature, attending clinical team meetings, etc. Attend periodic training sessions to increase and maintain knowledge of FDA regulations, drug development process and regulatory documents requirements.
- May assist with departmental or study-specific presentations (internal and external).
- Provide backup support to study team when they are traveling.
- May perform other assigned tasks as required
Minimum Requirements:
- Associate’s degree in a scientific or health care discipline with more than 2 years' experience in clinical trials research; or a mix of a Certification or Registration as a Medical Assistant with 2+ years working in a clinic-setting and medical terminology/anatomy and physiology knowledge. Must be an LPN, CMA, or RMA.
- Must be comfortable with venipuncture and collection of specimens for clinical research.
- Prior experience working with a Project and Trial Master File in a regulatory environment.
- Prior experience managing and maintaining a CTMS for one or more studies.
- Experience in working with Finance on tracking Trial, Site and CRO budgets and processing project related invoices.
- Knowledge of clerical and administrative procedures and systems such as filing and record keeping.
- Must be organized and detailed-oriented, with excellent administrative skills.
- Proficient with Microsoft Office (Outlook, Word, Excel and PowerPoint). Other database and PowerPoint experience a plus.
- Knowledge of medical terminology is VITAL. Also a solid understanding of Diagnoisis Codes is important for the position.
- Thorough understanding of principals of Good Clinical Practices is critical.
- Must possess strong written and verbal communication skills.
- Comfortable interacting with physicians and study team; taking directions, taking the initiative, and being a partner to the Clinical Research Director is if the utmost importance.
BENEFITS AND PAY
Pay is dependent upon experience. Paid on a bi-weekly basis, with direct deposit. Pay is commensurate with experience, but in-line with local fair-market value.
There is a generous benefits package, to include medical, dental, and vision insurance, LTD, Life Insurance, 401K investment program, and several additional voluntary insurance options. Paid major holidays. PEAK pays 50% of the employee’s health insurance premium (employee only).
INTENT AND FUNCTION OF THIS JOB DESCRIPTION
All descriptions have been reviewed to ensure that only essential functions and basic duties have been included. Peripheral tasks, only incidentally related to each position, have been excluded.
Requirements, skills, and abilities included have been determined to be the minimal standards required to successfully perform the positions. In no instance, however, should the duties, responsibilities, and requirements delineated be interpreted as all inclusive. Additional functions and requirements may be assigned by supervisors as deemed appropriate.
In accordance with the Americans with Disabilities Act, it is possible that requirements may be modified to reasonably accommodate disabled individuals. However, no accommodations will be made which may pose serious health or safety risks to the employee or others or which impose undue hardships on the organization.
Job descriptions are not intended as and do not create employment contracts. The organization maintains its status as an At-Will employer. Employees can be terminated for any reason not prohibited by law.
** Front Range Endoscopy Center, Peak Gastroenterology Associates, P.C., and Surgical Center of Peak Endoscopy are Equal Opportunity Employers**
Job Type: Full-time
Job Location:
Required education:
- High school or equivalent
Required experience:
- Clinical Research/Trial Associate: 3 years
Required language:
- Bilingual is incredibly helpful
