Experienced Clinical Research Associate (CRA II/Sr CRA) - US Central - Multiple Therapeutic Areas Available

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 monitoring tasks in accordance with the approved monitoring plan.
• Escalates observed deficiencies and issues to clinical management expeditiously and follows up to resolution.
• Participates in the investigator payment process.
• Facilitates effective communication between investigative sites, the client company, and the PPD project team.
• Responds to company, client, and applicable regulatory requirements/audits/inspections.
• Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner.
• Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
• Contributes to other project work and initiatives for process improvement, as required.

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 or equivalent and relevant formal academic/vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years 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.
• Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents.
• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
• Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
• Effective interpersonal skills.
• Attention to detail.
• Ability to remain flexible and adaptable in a wide range of scenarios.
• Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software.
• Good English language and grammar skills.
• Good presentation skills.

Benefits

The salary range estimated for this position based in Illinois is $66,800.00–$125,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• 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 (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy.
• Retail and savings programs, such as our competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount.

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards