Clinical Research Coordinator

Responsible for planning, implementing and coordinating the activities of local and national clinical research projects in the UBC Multiple Sclerosis (MS) and Neuromyelitis Optica (NMO) Clinic and collaborating national and international sites. Responds as required to the informational needs of potential subjects, health care workers, and the public regarding MS and NMO research.

This position is situated in the Djavad Mowafaghian Centre for Brain Health at the UBC Hospital site. Working conditions consist of locked office with office furnishings and a networked PC and Internet environment. In addition to areas of the hospital, outpatient visits are performed in clinical offices, and research recording and communication occurs within the research office. Attendance at study meetings within the hospital, and travel to national/international conferences and study meetings occur several times a year.

Organizational Status

Reports to the MS and NMO Clinical Trials Group Manager, working under the Direction of the MS and NMO Clinic/Clinical Trials Directors. Works independently to support national site Coordinator s in conducting national Investigator Sponsored Trials (IST). Works in collaboration with the Research Manager and Director to initiate and conduct international industry trials in MS and NMO. Liases with Principal Investigator(s), research ethics committees and Pharmaceutical Company representatives or funding sources who are initiating or monitoring research studies. The position must work independently and within standard and acceptable boundaries for ethical and competent research practice. The position will be accountable to the Research Manager, Principal Investigator and Sub Investigators as well as within the guidelines of Multiple Sclerosis Clinical Trials group staff practices at UBC Hospital.

Work Performed

- Performs research functions; planning, implementing national investigator sponsored trials.

- Builds and fosters effective working relationships with national sites while coordinating and co-monitoring national site study progress.

- Responsible for planning, managing and handling communications related to research projects in collaboration with the Research Manager.

- Responsible for setting goals in order to meet project deadlines in collaboration with the research team.

- Responsible for writing local investigator sponsored trial project proposals and ensuring the appropriate work plans and timelines are followed by the study team.

- Provides expertise in the field of research processes and policies while working in collaboration with the Research Manager.

- Prepares submissions for the Clinical Research Ethics Board. Responsible for HR activities of the MS/NMO Clinical Trials Group locally, including but not limited to appointment renewals and management of training activities and license renewals.

- Recruits research subjects and devises strategies for effective recruitment.

- Writes and implements project proposals including budgets.

- Implements study procedures in accordance with research protocols.

- Ensures study conduct with adherence to ICH-GCP guidelines

- Informs the investigator of the clinical progress of the study subjects.

- Meets with pharmaceutical company representatives, consultants and Contract Research Organizations (CROs) for trial initiation, maintenance and monitoring of subjects visits.

- Works closely with the MS and NMO Clinical Trials Group manager to supervise the junior Research Coordinators and Research Assistant/Technicians.

- Works with the Finance Coordinator to develop research budgets and funding applications.

- Provides assistance to the MS Clinical Trials Manager in collaborating on national investigator sponsored trials and international industry trials • Provides input on organizational improvements.

- Acts as a key liaison with research manager, Principal Investigator (PI), sponsors and Contract Research Organizations (CRO S).

- Transmits study data to sponsors with strict adherence to privacy and confidentiality guidelines (GCP).

- Ensures enrolment expectations are met.

- Informing the research manager, investigator and sponsor of any Serious Adverse Events to subjects during the trial.

- Communicates regularly with the help desk teams of different sponsors to address technical problems on site or with study devices.

- Conducts the close out of the study ensures proper storage according to regulatory requirements.

- Monitors subject progress: Identifies, problem-solves, monitors and assesses subjects for adverse events and adherence to protocol under direction of the Investigator.

- Attends investigator meetings, teleconferences and education/workshop sessions.

- Communicates and coordinates study related activity with (UBC and VGH) MS Clinical Trials staff, nursing staff, laboratory staff, pulmonary function, Pharmacy staff, and MRI staff.

- Pays strict attention to detail, maintains a high level of organization and a strong commitment to meeting study timelines.

Regulatory Activities:

- Exercises professional judgment in regulatory conduct of research activities, and ensures the MS Clinical Trials group strict adherence to local, national and international regulations on how to conduct clinical trials (PIPA, PIPEDA, ICH/GCP)

- Prepares study startup documents including regulatory requirements for sponsors and ethical approvals. Prepares study amendments and ensures updated study renewals; communicates with the UBC Clinical Research Ethics Board and supervises junior staff on regulatory and ethics board requirements.

Other tasks:

• Traveling as required to attend meetings and conferences.

• Assisting in subject recruitment for studies

• Acting as a blinded interviewer for studies as required

• Acting as a backup coordinator for other studies with other PIs when necessary

• Maintaining education and training on ICH-GCP, Health Canada Div. 5, research involving human subjects

• Standard Operating Procedures and trial related training.

• Performing other related duties as required to meet study goals and timelines.

Consequence of Error/Judgement

Lack of careful attention to regulatory guidelines and approvals could suspend Investigator/physician and hospital/University as a site for further clinical research and/or funding. The performance
of clinical trials and research projects must strictly conform to appropriate regulations: 1) personal: maintaining professional behavior and respect for subjects and staff 2) local: the UBC Clinical
Research Ethics Board 3) Provincial: B.C. Privacy Act 4) Federal: Health Canada, International Conference on Harmonization, Tri-Council Policy Statement, Good Clinical Practice and 5)
International: U.S. Food & Drug Administration. Clinical mistakes made by the coordinator could be life threatening to subjects. Ensuring subject safety includes: 1) accurately judging study eligibility 2) being prepared for any side effects (expected or unexpected) and 3) updating clinical skills and knowledge to meet the demands of clinical complexity.

In addition, the Research Manager and PI rely on the coordinator to alert them to clinical problems and unexpected events concerning study subjects and trial conduct: 1) Lack of study enrollment
and completion of work according to deadlines would threaten loss of funding and consideration for future invitations to participate in clinical trials and 2) Poor communication skills with subjects
would jeopardize their participation, and with sponsors and referring/community physicians would reflect badly on the reputation of the research group.

Supervision Received

Training and supervision for the Research Coordinator will be provided by the Research Manager. Reports directly to the Research Manager. The PI and/or his/her designate will provide broad directives. The coordinator collaborates with the Research Manager and CRO s.

Supervision Given

The coordinator advises/educates nurses, other research staff, contracted service providers, laboratory staff and UBC/VGH laboratory staff, who are involved with the subjects or study conduct on the study protocol(s). The coordinator also acts as a resource with hospital staff, subjects and colleagues, and manages subject progress and follow-up.

Minimum Qualifications

Undergraduate degree in a relevant discipline. Minimum of three years of related experience, or the equivalent combination of education and experience.

- Willingness to respect diverse perspectives, including perspectives in conflict with one’s own

- Demonstrates a commitment to enhancing one’s own awareness, knowledge, and skills related to equity, diversity, and inclusion

Preferred Qualifications

CH-GCP Certification and experience working under international regulatory guidelines is preferred. Previous experience with the UBC Clinical Research Ethics board preferred. Experience with
psychometric testing and knowledge of standard neuropsychological tests required. Working knowledge of research methodology and design. Experience in a supervisory role an asset. Ability to
exercise judgement and make decisions in accordance with the broad research objectives. Ability to independently organize workload. Computer proficiency mandatory, including use of Word and
Excel spreadsheets and similar applications. Knowledge of statistical methods and database applications is an asset. Effective interpersonal, oral and written communication, organization and
problem-solving skills. Ability to maintain accuracy and attention to detail and to work effectively under pressure to meet deadlines. Ability to work effectively independently and in a team
environment. Ability to exercise tact, discretion and diplomacy. Availability for some after-hours and week-end work required.