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 SOPs.
Reviews study data from various sources remotely. Develops collaborative relationships with investigational sites and other stakeholders as applicable.
May contact the study sites to collect study documentation, resolves issues and requests outstanding information if applicable.
Detailed tasks and responsibilities assigned to RSM-Central or RSM-Local positions are outlined in the task matrix.
Essential Functions :
According to the specific role (Central or Local) may coordinate, oversee and complete assigned trial activities 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 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, etc.
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.
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.
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 a life science-related field OR Registered Nurse license along with an Associate’s Degree in Nursing.
Current PPD CRAs qualify to be considered for this role without having the degree requirements.
Prior clinical research experience 1-2 years as well as knowledge of clinical monitoring through classwork / training that provides the required knowledge skills and abilities.
In some cases, previous experience in a clinical environment where experience is gained in clinical trials, data management, medical terminology, medical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.
Prefer individuals who aspire to advance into a CRA role.
Knowledge, Skills and Abilities :
Basic medical / therapeutic area knowledge and 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 successfully complete the RSM Onboarding Workshop
Ability to evaluate medical research data
Ability to advise, counsel, and motivate investigational sites
Effective oral and written communication skills with the ability to communicate effectively with medical personnel
Excellent interpersonal and customer service skills
Good 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
Working Environment :
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.
Below is listed the working environment / requirements for this role :
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.
Ability 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 require travel. (Recruiter will provide more details.)