Remote Clinical Research Associate Job
This is a remote role that involves performing activities on assigned projects in coordination with the internal study team. The successful candidate will provide support with site preparedness, logistical support to the monitoring process, and assist with assigned tasks for site management and remote monitoring in accordance with SOPs and regulatory guidelines.
* The job requires completing study and site management activities as defined in task matrices, and as applicable and directed for the assigned studies.
* The ideal candidate will complete and document study-specific training, orient and train on any CRG/study-specific systems, and provide in-house support during pre-study assessments.
* Responsibilities also include performing remote review of EMR/EHR checklists and supporting collection, as applicable assessments; verifying document collection and RCR submission status; updating site EDL and verifying site information.
* The job involves reviewing patient-facing materials and reviewing translations, as directed, supporting site staff with the vendor qualification process, ensuring system access is requested, granted or revoked for relevant site staff throughout the study.
* Ongoing responsibilities include coordinating and supporting logistics for IM attendance, as directed, supporting maintenance of vendor trackers, as directed, and coordinating study/site supply management during pre-activation and subsequent course of the study.
* The role requires resolving missing vendor data such as ECGs, lab samples, and e-diaries, as directed, conducting ongoing remote review of centralized monitoring tools, as directed, and facilitating the site payment processes by coordinating with various functional departments within the organization and with the site.
* Additional responsibilities include supporting system updates and reconciliations and following-up on site invoices throughout the study period, performing reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs and safety reports, as applicable.
* The job involves verifying document collection status in CRG systems and driving action for missing/incomplete/expired documents and open document findings, as directed, and may perform other assigned site management tasks, as directed by study team and as per Task Matrix.
* Maintaining & completing administrative tasks such as training, expense reports and timesheets in a timely manner is essential for this role.
Required Skills and Qualifications
* Bachelor's degree or equivalent in the area of health/medical science or nursing is required.
* Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years) is necessary.
* Basic medical/therapeutic area knowledge and understanding of medical terminology are essential.
* Able to attain and maintain a working knowledge of ICH GCP, applicable regulations and CRG procedural documents.
* Effective oral and written communication skills, excellent interpersonal and customer service skills, good organizational and time management skills and strong attention to detail are required.
* Proven flexibility and adaptability, ability to work in a team or independently, as required, well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
* Proficient computer skills with good knowledge of MS Office ability to learn and use appropriate software.
* Excellent English language and grammar skills.
Benefits
* Comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
* Flexible arrangements to balance work and personal life.
* Generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave.
* Paid volunteer time to support non-profit organizations that matter.
* Access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.
Work Environment
* Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
* Able to work upright and stationary for typical working hours.
* Able to work in non-traditional work environments.
* Able to use and learn standard office equipment and technology with proficiency.
* Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
* May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.
* This role may require independent travel up to 40%, inclusive of traveling in automobiles, airplanes, and trains.