Job Description:

The goal of this position is to assist the Clinical Trials Department with the maintenance of several complex ongoing clinical trials with a focus on patient-specific responsibilities. Responsible for the following aspects of the Clinical Trials process including but not limited to: Lead CRA coordinating study activities, monitoring of study compliance, maintenance of electronic data systems (EDC) to ensure accurate data entry, ensuring patient safety, study start-up procedures, consenting patients, monitoring patients on trials and toxicity assessment under direction of the principal investigator, maintaining and updating study databases, entering patient’s visit in the Clinical Trials Management System (CTMs), overseeing processing/storing/shipping of lab specimens, ethics submission and ongoing regulatory monitoring and trial procedures. Exercises considerable independent judgement and decision making, using broadly defined policies, practices and procedures, to resolve a variety of complex problems.

Education:

• 4-year Undergraduate Degree in Health Science – required or recognized equivalent of education and experience

• Certified Clinical Research Professional (either SOCRA or ARCP Certification) – required

• Clinical Research Graduate Certificate (preferred)

Experience:

• 2 years of experience in Oncology Clinical Trials

• Experience using data management software application, required

• Experience with patient management not limited to consenting, completing Patient Reported Outcome (PRO) etc. required

• Experience with processing specimens (preferred)

Competencies:

• Demonstrated analytic, problem-solving and attention to detail skills

• Documented expertise of provincial, national and international regulatory guidelines (e.g. PHIPA, PIPEDA, ICH-GCP, Health Canada Division 5, Tri-Council Policy Statement, etc.) is compulsory

• Applies knowledge of clinical research principles and practice

• Knowledge of medical terminology, required

• Knowledge of applicable legislative, RVH and /or departmental policies

• Applies knowledge of drug development processes and interaction with industry

Other:

• Position has a high level of accountability in that discussions and decisions regarding study data management, is done with minimal to no supervision

• Ability to multitask and change priorities without supervision

• Position generates many competing priorities

• Position requires excellent organization, time management, people skills, ability to communicate and collaborate with internal and external partners

• Position is highly detail oriented

Responsibilities:

Clinical Trials Leadership:

• Oversees several complex ongoing clinical trials as Lead CRA with a focus on patient-specific responsibilities. Leads departmental projects i.e. act as Lead CRA for studies assigned to them by participating in implementation of clinical research protocols Follows study protocol and institutional policies/ procedures. Leads study and regulatory coordination from activation to close-out of Phase II, III and IV for complex and high-risk clinical studies.
• Acts as a resource/mentor to new staff members.
• May advise and strategize with pharmacy team, physicians, and study teams regarding protocol amendments.
• Responsible for creating or amending source templates for documentation purposes in accordance with data management requirement Responsible for overseeing/supervising specimen management.

Patient Care:

• Clinical informed consent process - provide informed consent for non-interventional studies to patient and discuss clinical trial with patient and family/friends
• Provide and discuss with trial patient(s) in follow-up phase of trial, any new published information regarding their protocol treatment, if it becomes available
• Ensure quality of life questionnaires are completed according to the protocol requirements.
• Assesses patient for toxicities. Documents toxicities with collaboration of investigator and nurse. Conduct assessment per protocol, as delegated and as required.
• Reports all adverse reactions according to protocol guidelines
• Acts as a resource for study patients regarding conduct of clinical trial
• Maintains accurate data collection, through direct interviews with the protocol patients for the duration of the study and coordinates the order of investigations and appointments according to protocol requirements

Data Management:

• Reviews, evaluates and verifies clinical data to ensure accurate and timely completion of internal, pharmaceutical company and cooperative group case report forms (CRF's) in either paper or electronic format.
• Ensures quality assurance through accuracy and timeliness of submitted documentation and ensures that all data can be verified in the source document
• Verifies patient eligibility (for non-interventional studies) for study participation based on medical records in accordance with protocol requirements
• Validates the significant and relevant aspects of the subject's medical history, assessing baseline adverse events and concomitant medications, previous treatments and response to them (e.g. determining the grade and stage of cancer. Assessing the dates of diagnosis and recurrence and/or progression and entering into CRF’s.)
• Confirm protocol treatment drug doses to ensure accuracy and to ensure that any protocol specified dosage modifications have been made correctly and any discrepancies brought to the Principal Investigator’s attention.
• Obtains and submits all relevant diagnostic, laboratory, pathologic etc. reports when required to sponsors to provide corroboration of information recorded in CRF’s
• Responsible for maintaining systems for effective data flow and ensuring timeliness of submission for CRF’s.
• Data entry reporting in a timely manner, respond to data queries for external partners

Coordination and Communication with Internal and External Partners:

• Interacts with both internal and external contacts, primarily for the purposes of exchanging and/or clarifying of information and resolving problems within scope of authority
• Works well with people from different disciplines
• Demonstrates excellent competency in written and verbal communication
• Organizes remote and onsite monitoring visits for audits by external sponsors, internal and/or external regulatory agencies
• Supports site initiation visits and protocol reviews including presentations and source documentation collection, ongoing study operation, and closure of all new trials.
• Coordinate/communicate with Sponsors Study Managers, Clinical Research Associates, Research Ethics Boards, Monitors and Auditors throughout study duration (including closure and ongoing follow up)

Administrative:

• Creates or amends source templates for documentation purposes in accordance with data management requirements
• Create/maintain Patient database by clinical trial
• Create reports from databases including Monthly Reports for Managers and Director; active trials list for the sites etc.
• Assists Manager with maintaining financial statistics for trials
• Review the protocol and enter study information including procedures for each study visit in to Clinical Trials Management System (CTMS), and ongoing CTMS management to ensure CTMS remains updated

Training/ Regulatory & Ethics:

• Creates and implements study staff training in accordance with standard operating procedures
• May act as the RVH Oncology Trials contact representative for all communication, training, site visits, etc. for various sponsor-specific site roles
• May advise and strategize with coordinators, physicians, and study teams regarding protocol amendments
• Acts as a resource/mentor to new staff members by participating in orientation of new personnel and students as required
• May provide guidance and support to assigned personnel
• Identifies and pursues own learning needs, attends in-services and site-specific conferences, participates in continuing education and/or oncology research-related professional activities