Summarized Purpose :
Performs site management and other related activities on assigned project(s) in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and PPD SOP.
Reviews study data from various sources remotely. Develops collaborative relationships with investigational sites and other stakeholders as applicable.
May contact study sites to collect study documentation, resolves issues and requests outstanding information. Detailed tasks and responsibilities assigned to RSM-Central or RSMLocal positions are outlined in the task matrix.
Works proactively and independently, requiring no or minimal supervision. Supports the line manager to mentor, train and contribute to the development of junior clinical team members.
Essential Functions According to the specific role (Central or Local) may coordinate, oversee and complete assigned trial activities as detailed on the task matrix, including but not limited to the following : Develops and maintains a close and collaborative communication with the site staff.
Actively discusses protocol conduction, enrollment rates and strategies, open issues, EDC completion and queries, as well as any other topic or indicator associated to project status and site performance.
Completes / tracks / follows up ETRTR for subject data present in the EDC and other applicable systems, according to the study-specific guidelines.
Raises manual queries in EDC when applicable. Remotely reviews study logs as deemed necessary. Conducts and documents site management calls / contacts according to the monitoring plan.
Participates in investigator meetings. Investigates and follows up on centralized monitoring findings. Evaluates PI oversight (e.
g., protocol adherence), subject safety and study processes in order to assess site’s ability to conduct study on a regular basis.
Conducts remote investigations into site performance using a risk based monitoring approach : applying root cause analysis (RCA), critical thinking and problem-solving skills to help identify site process failure and work on corrective / preventive actions to bring the site into compliance and decrease risk.
Provides refresher training, follows up on outstanding administrative needs (e.g., outstanding / updated regulatory documents), assists with regulatory reviews, as requested.
Reviews ad-hoc clinical listings review, tracks and trends violations and deviations, site status, enrollment, CRF status and SAE follow up.
Provides trial status tracking and progress update reports to study manager as required. Participates in the investigator payment process, if applicable.
Liaises with internal staff to promptly collect documents, review data points and findings from EDC and file reviews, etc.
Assists in ensuring audit ready files and complying with CTMS and eTMF data stewardship. Contributes to company, client, and federal / local regulatory requirements / audit responses as needed.
Detailed task assignment and responsibilities are outlined on the task matrix, as well as any applicable protocol guidelines.
Education and Experience : Bachelor's degree in life science-related field or an Associate'sdegree in Nursing with a current RN license.
Internal applicants with currentor previous CRA experience will be considered with or without the educationrequirements.
Prior clinical research experience, 5+ years as well as knowledge of clinical monitoring through classwork / training that provides the required knowledge skills and abilities.
Prefer individuals who aspire to advance into a CRA role. In some cases an equivalency, consisting of a combination of appropriate education, training and / or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities : Excellent medical / therapeutic area knowledge and solid understanding of medical terminology Ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and PPD procedural documents Ability to successfully complete PPD’s Clinical Foundation Training Program (CFP) Ability to evaluate medical research data Ability to advise, counsel, and motivate investigational sites Highly effective oral and written communication skills with the ability to communicate effectively with medical personnel Excellent interpersonal and customer service skills Excellent organizational and time management skills Proven flexibility and adaptability Strong attention to detail 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.
Ability to coach and mentor site personnel. Good computer skills with good knowledge of MS Office ability to learn and use appropriate software.
Leverage modern technology when applicable Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards Excellent English language and grammar skills Proven ability to mentor junior team members effectively and efficiently, as needed.
Working Conditions and Environment : Work is performed in an office. Exposure to electrical office equipment.Physical Requirements : Ability to work in an upright and / or stationary position for 6-8 hours per day.
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
Frequent mobility required. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. Occasional light lifting and / or carrying of objects with a maximum lift of 5-15 lbs.
with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others to obtain or relate information to diverse groups.
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.
Ability to perform under stress. Ability to multi-task. Regular and consistent attendance.