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 remote or on-site monitoring activities, ensuring data accuracy through SDR, SDV, and CRF review.
• Assesses investigational products through physical inventory and records review.
• Documents observations in reports and letters using approved business writing standards.
• Escalates observed deficiencies and issues to clinical management and follows up until resolution.
• Maintains regular contact with investigative sites to confirm protocol adherence and data recording.
• Conducts monitoring tasks in accordance with the approved monitoring plan.
• Participates in the investigator payment process.
• Collaborates with clients to identify acceptable investigative sites.
• Initiates clinical trial sites and ensures compliance with the protocol and regulatory obligations.
• Performs trial close-out and retrieval of trial materials.
• Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
• Conducts on-site file reviews as per project specifications.
• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM).
• Facilitates 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 project publications/tools and shares ideas/suggestions with team members.
• Assists 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 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.
• Good organizational and time management skills.
• 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

• Comprehensive Total Rewards package including medical, dental, vision, commuter benefits, tuition reimbursement, paid time off, holidays, parental leave, accident and life insurance, short- and long-term disability, retirement and savings programs, and ESPP.

Pay

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.

Schedule

Standard (Mon-Fri)

Environmental Conditions

Office