CRA l - (Clinician to CRA Program)

Summarized Purpose

Performs and coordinates different 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. 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.

Essential Functions

• 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/preventative actions to bring the site into compliance and decrease risks.
• Ensure data accuracy through Source Data Review (SDR), Source Data Verification (SDV) and Case Report Form (CRF) review as applicable through on-site and remote monitoring activities.
• Assesses 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 follows 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 shared responsibility with other project team members on issues/findings resolution.
• Investigates and follows-up on findings as applicable.
• Participates in investigator meetings as necessary.
• May help to identify 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.
• Performs 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.
• Provides trial status tracking and progress update reports to the team as required.
• Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System (CTMS)).
• Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts.
• Responds to company, client and applicable regulatory requirements/audits/inspections.
• Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner.
• Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.
• Contributes to other project work and initiatives for process improvement, as required.
• Travel requirement >75%.

Qualifications

• Clinicians such as RNs, APRNs, PA’s, MDs, Research Nurse or Clinical Research Coordinator with clinician certification or equivalent and relevant formal academic/vocational training.
• Comprehensive experience as a clinician in a healthcare environment (comparable to at least 2 years) that provides transferable knowledge, skills, and abilities to perform the job in a clinical research environment.
• Expertise in a therapeutic area including, but not exclusive to Hematology/Oncology (solid tumor – Breast/Prostate) (Leukemias), CAR-T and Cell Therapy, Rare Disease, Endocrinology/Diabetes, Ophthalmology and Neurology (Alzheimer’s, Epilepsy), Cardiology, Infectious Disease, Respiratory/Pulmonology, Internal Medicine, ICU, or Critical Care (comparable to at least 2 years).

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 and applicable regulations and procedural documents
• Good oral and written communication skills, with the ability to communicate effectively with medical personnel
• Good interpersonal skills
• Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues
• Good organizational and time management skills
• Ability to remain flexible and adaptable in a wide range of scenarios
• 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 manage Risk Based Monitoring concepts and processes
• Ability to work in a team or independently as required
• Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
• Good English language and grammar skills