Supervisor Clinical Trials

Job Profile Summary

Tufts Medical Center is seeking a highly motivated and intellectually curious Clinical Trials Supervisor to join the Clinical and Translational Research Center (CTRC). The CTRC supports high-quality, innovative clinical research across Tufts CTSI partners and collaborators. Under the guidance of the Director of the CTRC, the center provides the infrastructure necessary to conduct cutting-edge clinical trials involving adult, and geriatric research participants. These trials focus on understanding the causes and progression of human diseases.

Job Overview

This position is responsible for the development, implementation, management and administration of the various industry and federally funded clinical trial protocols in the Tufts Clinical and Translational Science Institute (CTSI) Clinical and Translational Research Center (CTRC). Position will meet weekly with the Director of CTRC to discuss updates, performance of other clinical research staff, tasks of other clinical research staff, organization for all new clinical trials, performance on current trials, IRB status on all ongoing activities, enrollment and of all trials and how to accelerate. Position will interface with sponsors, monitoring organizations, and departmental and non-departmental personnel to assure a collaborative environment and high quality outcomes. Responsible for assisting with budget preparation in collaboration with Research Administration and working with hospital Clinical Research Office regarding contracting and IRB approvals.

Job Description

Minimum Qualifications:

1. Bachelor's degree.

2. Five (5) years of relevant experience.

3. Experience in clinical trial award set up, close out, and reconciliations.

Preferred Qualifications:

1. Master's degree relevant to clinical trial.

2. CITI Certification.

3. Previous research experience.

Duties and Responsibilities: The duties and responsibilities listed below are intended to describe the general nature of work and are not intended to be an all-inclusive list. Other duties and responsibilities may be assigned.

* In conjunction with Department Research Investigators, responsible for the supervision (hiring, training and performance evaluation) clinical trials staff.

* Disseminates information on available clinical trials in written and oral formats to Research Investigators.

* Maximize accrual onto clinical studies by serving as a liaison to physicians and fellows at TMC to answer protocol-related questions and to facilitate patient screening/entry onto clinical trials.

* Coordinate and manage patient recruitment.

* Interacts with Principal Investigators (PI's) and study staff to assure compliance to study protocols and requirements.

* Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.

* Travel to study sites and transport samples as needed. (A valid driver's license and reliable transportation are required.)

* Oversees and organizes data collection and Clinical Study Coordinator activities to monitor quality accuracy, and timeliness of data submission.

* Reviews proposed protocols with investigators to assess feasibility of undertaking projects.

* Assists in the opening of new studies and creating patient consent forms as needed.

* The ability to represent the PI and TMC to the affiliate hospital and deal effectively with personnel at all levels. Works with PI's to develop short and long term planning objectives for the clinical trials office.

* Maintains collaborative, team relationships with peers and colleagues in order to effectively contribute to the working groups achievement of goals, and to help foster a positive work environment

* Performs other similar and related duties as required or directed.

* Development and maintenance of IRB certification for ongoing and new studies, as requires. Work as a liaison with Tufts Medical Center's IRB and WIRB to facilitate approval of projects and ongoing documentation and reporting.

* Assists with design of databases and database functions and the creation of new databases or improvement of existing databases.

* Assist in production of materials for research reports and presentations, which may include drafting, editing, formatting, copying, collating, and/or mailings.

* Prepares summaries of peer comments and coordinates activities with researchers to make report changes which are responsive to peer comments.

* Responsible for online submission of manuscripts.

Physical Requirements:

1. Typical clinical and administrative office setting.

Skills & Abilities:

1. Highly self-disciplined, motivated and capable of self-direction within a defined scope of work.

2. Knowledge of FDA and CFR regulations.

3. Ability to be meticulous and detail-oriented.

4. Ability to interpret and apply sponsor, institutional and departmental policies and interpret policy for others.

5. Excellent written and oral communication skills.

6. Strong computer skills, including proficiency with MS Office (Word, Excel and Power Point), and familiarity with databases (e.g., experience using MS Access).

7. Computer programming, database, and statistical analysis skills.

8. Strong organizational skills with the ability to handle competing demands in order to meet project timelines.

9. Ability to work independently and collaborate within a team environment.

10. Ability to multi-task and prioritize responsibilities as needed.

11. Ability to conduct medical literature searching and retrieval.