Senior Clinical Research Associate (Remote) | Expression of Interests
- Auckland
- Permanent
- Full-time
- Monitors investigator sites with 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.
- Maintains 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 trial status tracking and progress update reports to the Clinical Team Manager (CTM) 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.
- May participate 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 and remote file reviews as per project specifications.
- Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g., trip report review, newsletter creation, lead CRA team calls etc).
- Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
- Responds to company, client and applicable regulatory requirements/audits/inspections.
- Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
- Contributes to other project work and initiatives for process improvement, as required.
- 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 4+ years as a clinical research monitor). Monitoring experience in phase-I healthy volunteers studies is essential.
- Valid New Zealand driver's license is required and ability to drive.
- 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.
- Effective clinical monitoring skills
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Excellent understanding and demonstrated application 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
- Ability to manages Risk Based Monitoring concepts and processes
- Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
- 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.
- This role requires independent travel up to 60%, inclusive of traveling in automobiles, airplanes, and trains.
- As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.
- You must possess unrestricted work rights i.e. NZ Citizen and/or Permanent Resident or equivalent