What are the responsibilities and job description for the Clinical Trial Associate position at TSP, a Syneos Health company?
Description
CLINICAL TRIAL ASSOCIATE
PURPOSE
The Clinical Trial Associate (CTA) will provide support to the Clinical Operations Team, including activities related to clinical trial coordination, planning, execution, and close-out. Key activities include maintenance of study tracking, filing and documentation, and providing administrative support in accordance with FDA regulations, Good Clinical Practice (GCP), and company standard operating policies and procedures.
Key Roles And Responsibilities
Performing the responsibilities of the job requires the ability to use hands and fingers to handle or feel and to manipulate keys on a keyboard. Occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch, or crawl. Ability to read and type while sitting in front of a computer up to 4 hours at a time. Vision abilities required by this job include close vision. May occasionally have to lift, tug, and pull up to 25 lbs.
WORK ENVIRONMENT
This job operates in a professional office environment. This role routinely uses standard office equipment, including computers, phones, photocopiers, filing cabinets, and fax machines.
Curevo offers its employees a generous range of compensation and benefits.
The salary range for this position is $85,000 - $95,000 annually. The salary range may vary based on Curevo’s compensation practices and an applicant’s qualifications and experience.
Employees have the opportunity to earn an Annual Discretionary Bonus, as well as being eligible to participate in Curevo’s Discretionary Equity Awards Plan. Our Employee Benefits program includes medical, dental, and vision plans, effective on the first of the month after your hire date, Flexible Spending Account, Health Savings Account, company provided Life and AD&D Insurance as well as LTD Insurance, a 401(k) Plan (eligible on day 1) with company match, cell phone reimbursement, and a variety of supplemental benefits that you may choose to elect. We have a Flexible Vacation Plan, a Paid Sick Leave Plan, and earn 1 hour of sick time for every 30 hours worked, plus 10 paid holidays per year.
At Curevo, we believe the highest-performing teams include people from diverse backgrounds and experiences who respectfully challenge one another and enjoy working and engaging together. We are committed to building an open, diverse, and inclusive culture for all employees.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
Curevo is proud to be an equal opportunity employer and does not discriminate based on race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status, or any other characteristics protected under applicable federal, state, and local laws.
About Curevo Vaccine
Curevo Vaccine is a clinical-stage biotech company pioneering the development of vaccines for unmet needs. Our overall goal is to bring a safer, well-tolerated, highly effective shingles vaccine to the market with a high-yield manufacturing process for rapid global availability.
Attention: Search Firms / 3rd Party Recruitment Agencies
The Talent Acquisition / HR team manages the recruiting for all positions at Curevo Vaccines. We will only accept resumes from a search agency/recruiter if we have a signed agreement in place and the Talent Acquisition / HR team has formally requested your help on a specific role. Unsolicited resumes sent to Curevo Vaccine will be considered the property of Curevo Vaccine. Curevo Vaccine will not be responsible for any fees associated with hiring from unsolicited resumes.
Recruiters are requested not to contact or present candidates directly to our hiring managers or employees, and doing so may jeopardize eligibility to work on future positions.
CLINICAL TRIAL ASSOCIATE
PURPOSE
The Clinical Trial Associate (CTA) will provide support to the Clinical Operations Team, including activities related to clinical trial coordination, planning, execution, and close-out. Key activities include maintenance of study tracking, filing and documentation, and providing administrative support in accordance with FDA regulations, Good Clinical Practice (GCP), and company standard operating policies and procedures.
Key Roles And Responsibilities
- Function as a central contact for designated project communications, correspondence, tracking, and documentation. Help plan, organize, attend, and take minutes for study and program-related meetings.
- Assist with the development and maintenance of clinical tools and trackers to track data, including, but not limited to, study start-up activities, screening, study enrollment, study team contact lists, study team training, decision logs, frequently asked questions, and risk management matrices.
- Develop study-specific TMF plan(s) and manage/oversee the collection, tracking, and archiving of Essential Documents throughout the life of the study.
- Manage the Clinical Operations internal document filing system and documents.
- Ensure inspection readiness by assisting with the set-up, maintenance, and performing quality control reviews of the Internal Trial Master Files (eTMF) and the CRO’s Trial Master Files. Work with CRO to resolve discrepancies.
- Assist in quality control reviews of clinical study documentation (e.g., Sites' regulatory binder, source documentation, Monitoring visit reports, etc.).
- Assist with the creation of PowerPoint slides for activities such as Site Initiation Visit presentations, Investigator Meetings, and other study-related team trainings, or other presentations as assigned.
- Collaborate with Clinical Trial Managers, Clinical Trial Specialists, and Contract Research Organizations (CRO) and vendors to support ongoing trial monitoring activities.
- Coordinate and contribute to the preparation and review of trial-related materials (Informed Consent Forms, Case Report Forms, Standard Operating Procedures, Monitoring Plans, Laboratory Manuals, Pharmacy Manuals, Study Reference Manuals, Diaries, CRFs).
- Coordinate document translation, if required.
- Assist in the coordination and tracking of IP supply (including at the depot and clinical sites), lab and kit supplies, and laboratory sample tracking and clinical research specimen shipments.
- Order and maintain ancillary clinical study supplies required for the conduct of clinical trials.
- Proactively identify, triage, and coordinate resolution of clinical study issues, as assigned.
- Participate in reviewing data entered in data capture systems, data listings, and reports, and assist team members with issues and resolve queries.
- Actively participate in process improvement.
- Other duties as assigned.
- BA/BS or equivalent degree in life sciences.
- Prior experience in clinical research or another regulated environment.
- CCRA/CCRP certification.
- Prior experience in a small biotech environment, CRO, and/or clinical vaccine research clinical site.
- Understanding of clinical trial site monitoring
- Prior experience with Trial Master Files
- Prior experience of clinical trial E-Systems (e.g., EDC (Electronic Data Capture).
- Proficiency in MS Office [Excel, Word, PowerPoint] and Adobe Acrobat. Experience with project management software or cloud systems (i.e., Smartsheet ).
- Familiar with or willing to learn applicable regulations and guidelines (e.g., FDA Code of Federal Regulations as applicable to clinical study conduct; International Conference on Harmonization Guidelines for Good Clinical Practice).
- Excellent oral and written communication skills.
- Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team and with clinical sites. Highly responsive and proactive, a team player.
- Exceptional organizational skills, ability to manage multiple tasks, and careful attention to quality/detail.
- Ability to work autonomously and multitask in a fast-paced environment.
- Ability to act with integrity and professionalism, and maintain discretion when handling confidential information.
Performing the responsibilities of the job requires the ability to use hands and fingers to handle or feel and to manipulate keys on a keyboard. Occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch, or crawl. Ability to read and type while sitting in front of a computer up to 4 hours at a time. Vision abilities required by this job include close vision. May occasionally have to lift, tug, and pull up to 25 lbs.
WORK ENVIRONMENT
This job operates in a professional office environment. This role routinely uses standard office equipment, including computers, phones, photocopiers, filing cabinets, and fax machines.
Curevo offers its employees a generous range of compensation and benefits.
The salary range for this position is $85,000 - $95,000 annually. The salary range may vary based on Curevo’s compensation practices and an applicant’s qualifications and experience.
Employees have the opportunity to earn an Annual Discretionary Bonus, as well as being eligible to participate in Curevo’s Discretionary Equity Awards Plan. Our Employee Benefits program includes medical, dental, and vision plans, effective on the first of the month after your hire date, Flexible Spending Account, Health Savings Account, company provided Life and AD&D Insurance as well as LTD Insurance, a 401(k) Plan (eligible on day 1) with company match, cell phone reimbursement, and a variety of supplemental benefits that you may choose to elect. We have a Flexible Vacation Plan, a Paid Sick Leave Plan, and earn 1 hour of sick time for every 30 hours worked, plus 10 paid holidays per year.
At Curevo, we believe the highest-performing teams include people from diverse backgrounds and experiences who respectfully challenge one another and enjoy working and engaging together. We are committed to building an open, diverse, and inclusive culture for all employees.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
Curevo is proud to be an equal opportunity employer and does not discriminate based on race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status, or any other characteristics protected under applicable federal, state, and local laws.
About Curevo Vaccine
Curevo Vaccine is a clinical-stage biotech company pioneering the development of vaccines for unmet needs. Our overall goal is to bring a safer, well-tolerated, highly effective shingles vaccine to the market with a high-yield manufacturing process for rapid global availability.
Attention: Search Firms / 3rd Party Recruitment Agencies
The Talent Acquisition / HR team manages the recruiting for all positions at Curevo Vaccines. We will only accept resumes from a search agency/recruiter if we have a signed agreement in place and the Talent Acquisition / HR team has formally requested your help on a specific role. Unsolicited resumes sent to Curevo Vaccine will be considered the property of Curevo Vaccine. Curevo Vaccine will not be responsible for any fees associated with hiring from unsolicited resumes.
Recruiters are requested not to contact or present candidates directly to our hiring managers or employees, and doing so may jeopardize eligibility to work on future positions.
Salary : $85,000 - $95,000