DSRB Analyst 8-month Temp

Areas of Responsibility

Percent of Time Spent

Measurement Criteria

1. Ethics Policy Management

1.1 Assists the Manager in preparation, regular review and update of research ethical guidelines, policies and standard operating procedures.

1.2 Perform secretariat duties to the NHG REC, if appointed.

1.3 Ensures that REC meeting minutes are in sufficient details to document board’s deliberations.

0.1FTE

Preparation of at least 1 REC paper per year.

Support REC led initiatives.

2. Ethics Review and Approval Process and Procedures

2.1 Ensuring Quality of Review

(a) Ensures that research protocols submitted to assigned Domain are reviewed efficiently and consistent with the applicable regulations, guidelines and policy

(b) Ensures that the Review Board’s reviewing processes are properly conducted, including meeting agendas, ensuring quorum, and document minutes of the meetings and follow up actions including correspondence to Investigators/ Sponsors.

(c) Ensures that meeting minutes are in sufficient details to document review boards’ deliberations.

0.3FTE

Timely and effective follow ups of Domain work to ensure that Domain is conducting reviews appropriately.

Specific Deliverables:

1. To hold and facilitate competently Full Board meetings at least once/month
2. To be engaged in study specific reviews at least 1x every alternate month

2. Ethics Review and Approval Process and Procedures

2.2 Ensuring Timeliness of Review

(a) Screens and reviews applications and correspondence received by the review boards and to oversee the accurate and timely processing, of submissions to and actions by the review board.

(b) Manage Domain operations and meetings

0.3FTE

Timely and effective follow ups of Domain work to ensure that Domain work are conducted timely.

To participate and engage in quarterly monitoring exercise on studies with long TAT.

Specific Deliverables:

1. To be engaged in study specific reviews at least 1x every alternate month

Specific Deliverables:

1. Manage 1 FB/month
2. Manage 1 Expedited chair mtg on weeks where there is no FB mtg.

2. Ethics Review and Approval Process and Procedures

2.3 Participate in Quality Improvement

Improve ethics approval process and effectiveness of review, as part of continuous improvement project

0.1FTE

Participate actively in discussions and lead 1 improvement initiative

2. Ethics Review and Approval Process and Procedures

2.4 Serve as resource for Investigators and researchers regarding the adaptation and implementation of DSRB policies, procedures and forms.

2.5 Effectively communicate and document all communications with Sponsors, Investigators, review board members and regulatory authorities.

0.1FTE

Give timely advice and effective resolution of concerns/feedback from investigators across Institutions

3. DSRB Database Management

3.1 Assists in preparing DSRB-related reports on ethics and other topics.

3.2 Maintains an accurate, comprehensive and up-to-date database of all applications.

0.05FTE

Be able to discern and capture information in reports.

Be accurate in reports.

4 Operational Matters of Administrative Support Office

4.1 Be involved in cross coverage plans for other Domains

4.2 Performs any other ad-hoc job-related duties as assigned.

4.3 Serve as the Secretariat of Ethics conferences/programs.

0.05FTE

Be able to provide sufficient coverage for other Domains when help is requested.

Demonstrate good team-work and willingness to handle Ad-hoc tasks without compromising the quality of the core-function.