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SalaryDescription
SR. CLINICAL RESEARCH ASSOCIATE/CLINICAL RESEARCH ASSOCIATE
Classification: Exempt
Reports to: Sr. Director Clinical Operations
Reports to: Sr. Director Clinical Operations
PURPOSE
The Clinical ResearchAssociate/Sr. Clinical Research Associate assists the clinical operations team in the oversight, organization, implementation, and completion of Clinical Research studies in compliance with Curevo guidelines and all applicable laws and regulations including Good Clinical Practice (GCP).
KEY ROLES AND RESPONSIBILITIES
- Support the Clinical Operations teams in study start-up, execution, and close-out.
- Provide general administrative support to the clinical operations team and may function as a central contact for designated project communications, correspondence, and associated documentation.
- Create and/or maintain various clinical tools such as the use of electronic CTMS systems or other electronic software/cloud systems to track data including, but not limited to study enrollment, study team contact lists, study team training, IRB applications, consent/re-consents at site, IP shipment tracking and laboratory sample tracking.
- 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 Research Associates, and Contract Research Organizations (CROs) to support ongoing trial monitoring activities.
- May perform Monitoring Oversight visits at clinical sites.
- Ensure Inspection Readiness by managing the set-up, maintenance, and quality control of the internal Trial Master Files (eTMF) and overseeing the CROs management of Trial Master Files.
- Manages the Clinical Operational internal document filing system and documents.
- Contributes to the preparation of trial-related materials (Clinical Protocols, Informed Consent Forms, Case Report Forms, Standard Operating Procedures, Monitoring Plans, Laboratory Manuals, Pharmacy Manuals, Study Reference Manuals, Diaries, CRFs).
- Assist project teams with study-specific documentation and guidelines as appropriate.
- Assist in the coordination and tracking of IP supply at depo and clinical sites, lab supplies, and Clinical Research specimen shipments.
- Actively order and maintain ancillary clinical study supplies required for the conduct of clinical trials.
- Assist with planning, preparation, and on-site support of investigators meetings.
- Coordinate logistics for clinical project meetings and preparation and distribution of meeting minutes.
- Ensure timely completion of study tasks and update trial trackers on an ongoing basis.
- Generate and distribute study newsletters.
- Proactively identify, triage, and coordinate resolution of clinical study issues.
- Assist with ensuring the Clinical Operations Team is up to date on ICH GCP regulations and revisions.
- Assist in quality control audits of clinical study documentation (e.g., Sites regulatory binder, source documentation, Monitoring visit reports, etc.).
- Assist in reviewing data entered in EDC by comparing to source documents, issuing, and resolving queries in EDC.
- Assist in the coordination of Investigator payments or resolving discrepancies, if applicable.
- Assist in the tracking and distribution of safety reports.
- Coordinate document translation with the assigned vendor, if required.
- Assist with the coordination of team member training tracking.
- Actively participate in process improvement.
- Other duties as assigned
PREFERRED EDUCATION
- Life Sciences (B.S. or B.A.)
- CCRA/CCRP certification preferred
PREFERRED EXPERIENCE
- Minimum of 4 years experience / 5 years for Sr. CRA in Clinical Research or another regulated environment. Prior experience in a small biotech environment, CRO, and/or clinical vaccine research clinical site is highly desirable.
KNOWLEDGE, SKILLS, AND ABILITIES
- Understanding of clinical trial site monitoring.
- Thorough understanding of FDA, ICH, and GCP regulations, guidelines, policies, and practices for conducting clinical trials.
- Knowledge of FDA 21 CFR Part 11 for Handling of Electronic Records.
- Strong working knowledge of medical/scientific terminology.
- Prior experience of clinical trial e-systems preferred (e.g., EDC (Electronic Data Capture), eSource, eISF (Investigative Site File).
- Proficiency in MS Office [Excel, Word, PowerPoint,] and Adobe Acrobat. Experience with project management software or cloud systems (i.e., Smartsheet) is a plus.
- Excellent oral and written communication skills; ability to communicate effectively with co-workers and clinical site personnel.
- Exceptional organizational skills, ability to manage multiple tasks, and careful attention to quality/detail.
- Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Highly responsive and proactive, a team player
- Ability to work autonomously and multi-task in a fast-paced environment.
- Ability to act with integrity, and professionalism, and maintain discretion when handling confidential information.
- Able to travel as required by projects (approx. 25% time as needed: US and international).
PHYSICAL DEMANDS
Performing the responsibilities of the job requires the ability to use hands and fingers to handle or feel and manipulate keys on a keyboard. Occasionally required to stand, walk, reach with arms and hands, climb or balance, and stoop, kneel, crouch, or crawl. Ability to read and type while sitting in front of a computer for 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 such as 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 $105,000 - $125,000 annually. The salary range may vary based on Curevos compensation practices and an applicants qualifications and experience.
Employees have the opportunity to earn an Annual Discretionary Bonus as well as being eligible to participate in Curevos 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 earning 1 hour of sick time for 30 hours worked, and 10 paid holidays per year.
At Curevo, we believe the highest-performing teams include people from a variety of backgrounds and experiences who respectfully challenge each other 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 on the basis of 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 property of Curevo Vaccine. Curevo Vaccine will not be responsible for any fees associated should we hire 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.
The salary range for this position is $105,000 - $125,000 annually. The salary range may vary based on Curevos compensation practices and an applicants qualifications and experience.
Employees have the opportunity to earn an Annual Discretionary Bonus as well as being eligible to participate in Curevos 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 earning 1 hour of sick time for 30 hours worked, and 10 paid holidays per year.
At Curevo, we believe the highest-performing teams include people from a variety of backgrounds and experiences who respectfully challenge each other 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 on the basis of 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 property of Curevo Vaccine. Curevo Vaccine will not be responsible for any fees associated should we hire 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.
