AddressSummarized Purpose: Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on- site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites and client company personnel. Assists project manager and takes a lead role. Supports the line manager to mentor, train and contribute to the development of junior clinical team members.
- Monitors investigator sites with particular ability to manage complex studies and/or challenging sites using a risk-based monitoring approach, applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable
- Provides updates on potential trends noted across multiple sites and discusses potential strategies for their management to the Project Manager.
- Contributes to the mentorship, training and development of junior CRAs. Assists in project specific training for the clinical team where necessary. Identifies areas for potential process improvements, share potential solutions & implement where appropriate.
- Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts
- Provides trial status tracking and progress update reports to the Project Manager as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required.
- Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures 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.
- Responds to company, client and applicable regulatory requirements/audits/inspections.
- Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
- Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines, SIV Training slides)
- Responsible for fostering and building site relationships for newly placed or returned placement of EDS studies, enhancing familiarity and ease of future working collaborations.
- Collaborates directly with the project manager throughout the conduct of the study in relation to site management and monitoring.
- May provide input into preparation of forecast estimates for clinical activities.
- May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. May also prepare material and present at client meetings, may include bid defense and hand-off meetings.
- Responsible for site management activities both on-site and remote, and typically serves as the single point of contact for sites conducting EDS trials.
- Supports the wider EDS team and study assigned Clinical Site Managers, to mentor, train and contribute to the development of junior Clinical Site Managers. Assists in project specific training for the clinical team where necessary. Identifies areas for potential process improvements, share potential solutions & implement where appropriate. May lead initiatives related to these areas for a broader evaluation and reach.
- Routinely serves in a lead coordinating position for studies with multiple sites and clinical management staff (e.g. Phase Ib, multi-center or multi-country studies).
- Coordinates the work of ROD monitors assigned to EDS Studies where necessary.
- Routinely acts as an accompanier and mentor for more Jr Clinical Site Managers.
- Serves as an aligned onboarding champion for new staff, offering exposure, shadowing and co-monitoring opportunities and training on EDS trial specificities.
Education and Experience:
Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
Considerable clinical research monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) with a demonstrated high level of expertise in all aspects of clinical monitoring.
Valid driver's license.
Knowledge, Skills, and/or Abilities:
- Expert clinical monitoring skills
- Expert knowledge of FDA guidelines, ICH GCPs, applicable regulations and procedural documents
- Excellent critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
- Proficient in Risk Based Monitoring concepts and processes
- Demonstrated ability to evaluate medical research data and proficient knowledge of medical terminology
- Excellent oral and written communication skills
- Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues
- Excellent interpersonal skills
- Ability to remain flexibile and adaptable in a wide range of scenarios
- Effective presentation skills
- Ability to work independently as required
- Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software
- Excellent interpersonal, collaborative relationship building, presentation, team building, organization, and time management skills.
- Able to engage with new sites not currently in the EDS Site Network to evaluate and build working relationships with, for future placement of EDS studies.
- Proven strength and skills to mentor, coach, develop and train more junior staff. Able to provide feedback with follow up, to other clinical Site Managers in a positive and effective manner.
- Capable of evaluating workload against project budget and communicating variances to Project Lead and/or Clinical Manager.
Working Conditions and Environment:
- Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.
- Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Personal protective equipment required such as protective eyewear, garments and gloves.
- Exposure to fluctuating and/or extreme temperatures on rare occasions.
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.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate complex information and ideas so others will understand; 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.
