TRiNDS is a telework corporation, having embraced the power of putting the right people together regardless of location. We are a team of highly skilled project managers, data managers and administrative professionals. TRiNDS provides a supportive and inclusive work culture where employees are empowered to own their work, teams are encouraged to have open dialogue and leadership is transparent and communicative.
TRiNDS is seeking a full-time Senior Clinical Trial Assistant (CTA) to support the TRiNDS team in day-to-day clinical research activities. The Senior CTA will work on multiple projects providing administrative support for ongoing clinical trials.
Primary Responsibilities:
- Track deliverables such as training, actions, metrics, documents, and timelines in the Clinical Trial Management System (CTMS) and run reports.
- Manage documents in the Trial Master File (TMF) and/or internal files, including filing, organizing, and reviewing documents from study setup to closeout.
- Perform routine quality checks of the TMF and coordinate with managers to implement corrections.
- Manage user access to the CTMS, EDC database, and eTMF.
- Format study documents.
- Interact with clinical research sites regarding administrative matters and to facilitate site staff study training according to study needs.
- Attend team meetings, take team meeting minutes, and send out team meeting communications.
- Assist monitors in preparing for clinical site monitoring visit(s).
- Act as a resource for data management needs such as performing quality checks/reviews of data management documents and general overflow support as needed.
- Assist with the creation, maintenance, and review of quizzes and surveys on various survey-making platforms.
- Adhere to TRiNDS Standard Operating Procedures (SOPs) and other controlled documents to maintain compliance.
- Contribute to TRiNDS controlled documents and other company needs.
- Train and mentor junior Clinical Trial Assistants (CTAs) in TRiNDS systems and procedures.
- Serve as the first point of contact for junior CTAs for CTMS and TMF issues.
Qualification Requirements:
- Bachelor of Science or other related field is preferred
- Clinical research background preferred, especially with clinical trial management systems and/or electronic TMFs
- Excellent skills with Microsoft office programs (Word, Excel, and PowerPoint)
- At least one year of experience working as a CTA or in another similar position.
- Strong oral and written communication skills
- Ability to manage and maintain several different tasks and to prioritize task completion
- Detailed oriented and comfortable working in a fast-paced and growing company
This position is primarily remote/work from home. If possible based on candidate’s location, travel may be required to our Pittsburgh, PA office up to once per month. Preference will be given to those candidates located on the East Coast.
For consideration, send a cover letter along with your resume.
About TRiNDS (Therapeutic Research in Neuromuscular Disorders Solutions): TRiNDS is a specialized contract research organization (CRO) dedicated to conducting high quality clinical trials in neuromuscular and rare diseases. TRiNDS offers expert dedicated solutions in trial management, clinical monitoring, site management, data management, study outcome measures, and other neuromuscular specific clinical research services. We are uniquely focused on muscular dystrophies, such as Duchenne muscular dystrophy (DMD), and our expertise has been drawn from the academic clinical trial network: The Cooperative International Neuromuscular Research Group (CINRG). TRiNDS bridges gaps for neuromuscular and rare disease clinical trials by engaging with key leaders in the field.
For more information, please visit: www.trinds.com
TRiNDS benefits are highly competitive to attract and retain top talent:
Compensation: We offer competitive compensation packages, inclusive of an individual performance bonus program.
Comprehensive Benefits: We provide a variety of benefits to support your financial security, health and wellbeing including retirement plans, health programs, life insurance and medical care.
Work-Life & Flexibility: We support you in maintaining a balance between working hours and personal life. As a telework company, we offer remote working arrangements in all areas in which we operate.
Training & Development: We are committed to your professional and personal development and encourage you in the ongoing pursuit of education, training, and knowledge through both formal and informal learning.
TRiNDS participates in the E-Verify Program'
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Work Location:
Work Remotely
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible schedule
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Retirement plan
- Vision insurance
Education:
Experience:
- Clinical Research CRO or Sponsor: 1 year (Required)
- Clinical Trial Management System Systems: 1 year (Preferred)
- Electronic Trial Master System: 1 year (Preferred)
Work Location: Remote
