Clinical Research Associate II - US Central - Multiple Therapeutic Areas Available
Thermo Fisher Scientific · Texas, United States · 2 wk ago
RemoteRemoteScienceFull-time
About the role
We are seeking a Clinical Research Associate (Level II) to join our dynamic team. This role involves performing and coordinating all aspects of the clinical monitoring and site management process, ensuring compliance with protocols, regulations, and guidelines.
Responsibilities
- Makes remote or on-site visits to assess protocol and regulatory compliance and manage required documentation.
- Manages procedures and guidelines from different sponsors and/or monitoring environments.
- Ensures audit readiness and develops collaborative relationships with investigational sites.
- Conducts remote or on-site monitoring activities to ensure data accuracy and investigational product assessment.
- Documents observations in reports and letters, escalating issues to clinical management and resolving them.
- Maintains regular contact with investigative sites to confirm protocol adherence and data recording.
- Initiates clinical trial sites, ensures compliance with protocols and regulations, and makes recommendations where necessary.
- Conducts on-site file reviews, prepares trial status reports, and updates study systems.
- Facilitates communication between investigative sites, clients, and the project team.
- Responds to company, client, and regulatory requirements/audits/inspections.
- Maintains and completes administrative tasks such as expense reports and timesheets.
- Assists in preparing project publications/tools and shares ideas/suggestions with team members.
- Participates in other project work and initiatives for process improvement.
Requirements
- Up to 80% travel is expected.
- Must be legally authorized to work in the United States without sponsorship.
- Must be able to pass a comprehensive background check, including a drug screening.
Qualifications
- Bachelor's degree in a life sciences related field or a Registered Nursing certification and relevant formal academic/vocational qualification.
- Previous experience as a clinical research monitor or completion of PPD Drug Development Fellowship.
- Valid driver's license where applicable.
Skills
- Proven clinical monitoring skills.
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
- Well-developed critical thinking skills, including critical mindset and problem-solving.
- Good oral and written communication skills.
- Effective interpersonal skills.
- Good organizational and time management skills.
- Good computer skills: solid knowledge of Microsoft Office.
- Good English language and grammar skills.
- Good presentation skills.
Benefits
The salary range for this position in Illinois is $66,800.00–$120,000.00. This position may also be eligible for a variable annual bonus based on company, team, and/or individual performance results. We offer a comprehensive Total Rewards package including:
- A choice of national medical and dental plans, and a national vision plan, including health incentive programs.
- Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
- At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave, accident and life insurance, and short- and long-term disability.
- Retail and savings programs, such as our competitive 401(k) U.S. retirement savings plan and Employees’ Stock Purchase Plan (ESPP).
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards