Sr. Clinical Trial Assistant

Job Description

The Senior Clinical Trial Associate (Sr. CTA) is responsible for supporting the daily workflow of clinical operations activities. The Sr. CTA provides administrative support to study teams throughout the study and serves as a mentor and coach for other CTAs. Key administrative activities include managing meeting invitations, creating agendas and meeting minutes, study document filing, maintaining study trackers, and oversight of the study-specific electronic Trial Master Files (eTMF).

Responsibilities

• Serve as a member of the clinical operations team and provide administrative support and tracking of trial status, aiming for efficient management of trials.
• Lead the onboarding effort for the eTMF.
• Set up and maintain the eTMF according to the eTMF Plan.
• Collect essential documents and perform quality control of documents/files as per study milestones outlined in the project plan.
• Collaborate with the clinical study team (internally and external CROs) to ensure the eTMF is audit/inspection ready.
• Provide administrative support to the clinical study team for study-related activities such as maintenance of study mailbox, newsletter creation/review, study document formatting, binders, and meeting minutes.
• Assist CTM and cross-functional leaders in the production of various study reports and updates.
• Plan and organize project-specific meetings, including internal clinical study team meetings, external service provider/partner meetings, CRA training, Investigator Meeting, and PI meetings. Create agendas, meeting minutes, and distribute them.
• Act as a point of contact for study-related requests from team members and service providers/partners.
• Assist with study start-up activities, including feasibility, investigator recruitment, and general site management support.
• Support the distribution and tracking of IND Safety Reports/SUSARS/CIOMS according to procedures defined by the study team.
• Coordinate the distribution and reconciliation of study material as required by the study.
• Support financial tasks for the study, including tracking investigator/institution/vendor payments.
• Review, validate, track, and file essential documents for investigational sites, following up on missing/incomplete/invalid documents.
• Lead other CTAs in overseeing the QC process of eTMF per project plan.
• Perform other duties as assigned by management.

Requirements/ Qualifications:

• 4 years of experience in a CTA role.
• 2 years of experience with Trial Interactive.
• Experience in a CRO or smaller biotech is a plus.
• Experience setting up a TMF is helpful.

Essential Skills

• Working knowledge of ICH/GCP and clinical research processes.
• Solid working knowledge and experience utilizing an eTMF platform(s).
• Professionalism, punctuality, ability to deliver on commitments, good interpersonal skills, and positive interactions with internal and external stakeholders.
• Effective verbal and written communication skills.
• Values and work ethic consistent with company values.
• High self-motivation, detail-oriented, ability to work and plan independently as well as in a team environment.
• Ability to develop, coach, and mentor CTA staff.
• Focus on continuous improvement and ability to make proactive assessments to improve processes.

Additional Skills & Qualifications

• 4-5 years of experience in a CTA role.
• 2-3 years of experience with trial interactive.
• Experience in a CRO or smaller biotech is a plus.
• Experience setting up a TMF is helpful.
• Ability to implement Trial Interactive.
• Ability to hit the ground running.

Pay and Benefits

The pay range for this position is $114000.00 - $126000.00

Competitive compensation and benefits which includes the opportunity for annual and spot bonuses, stock options and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off.
A commitment to learning and development which includes a variety of programming internally developed by and for employees, opportunities for job-specific training offered by industry, and an education reimbursement program.

Workplace Type

This is a fully remote position.

Application Deadline

This position will be accepting applications until Jan 31, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $114,000 - $126,000