Clinical Trial Manager

Overview

 

 

The Clinical Trial Manager Responsible for ensuring studies are being conducted in adherence with the protocol, ICH Good Clinical Practice Guidelines (GCP), FDA regulations, applicable Standard Operating Procedures (SOPs), policies and any other applicable regulations.Participate in the mentorship of project specific CRA education, training, and performance assessment for more junior clinical research staff. Maintains awareness of overall development in the field of clinical research. Assist in developing and updating SOP’s pertaining to the management of clinical studies according to GCP and regulatory requirements. May also serve as a combined Project Manager on specific clinical projects. Coordinate, educate, monitor, and provide technical and administrative support for the Clinical Research Trials. Assures studies are conducted in adherence to the protocol, GCP, Investigator integrity, and compliance with all study regulations. Experience reviewing technical documents, such as protocols, clinical study reports, and safety reports. Ability to think strategically working within a project. Excellent interpersonal skills and communication skills are a must. Computer proficiency in Microsoft Word, Excel, and PowerPoint. Travel is required.

Responsibilities

1. Complete compliance requirements on an annual basis.

2. Maintain Supplies to the department within budgetary parameters

3. Interact in a positive manner with other departments within the corporate office to facilitate the departmental projects.

4. Demonstrates a commitment to department objectives through consistent patterns of work behavior and positive representation.

5. Provides prompt, courteous, professional, and accurate information in all communications in dealing with physicians and other departments.

6. Responds to the department needs by accepting additional assignments, which may or may not be related to the job’s primary responsibilities to ensure the continuity of department services.

7. Responsible for following all facility, organization and department precautions and procedures in the performance of all job duties to ensure a safe work environment for self and others.

 

Performance Evaluations: Conduct performance evaluations as per standards of Pediatrix Medical Group for full time, part time and contract monitors of clinical trials.

1. Establish goals and performance objectives with the employee.

2. Conduct ongoing progress reviews.

3. Provide support to facilitate employee meeting their goals.

4. Conduct annual performance review .

 

Clinical Trials: Provide clinical monitoring expertise, support, and leadership for more junior clinical research staff.

1. Provide CRA education and training for specific projects.

2. Communicate new developments in clinical research to CRA’s.

3. Provide support in all areas of the trial(s) to field monitors.

4. Review paperwork submitted by field monitors to ensure compliance with the project.

5. Conduct on site evaluations with field monitors.

6. Conduct evaluation/surveys of field monitors with clinical site personnel.

 

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:

1. Site Selection: Assists with the identification and contacting of potential investigators; ensures adequacy of clinical research staff/facilities with regard to Pediatrix Medical Group, SOPs, and global regulatory requirements.

2. Study Initiation: Conduct site initiation visits. Ensure essential regulatory documents are in place; review investigator responsibilities; review the protocol and CRF; coordinate shipment of study-related materials if necessary; assist in the preparation for and attend investigator meetings.

3. Study Monitoring: On-site Monitoring: a. Site contact and notification of visit. b. Assesses overall investigator site performance by ensuring compliance with GCPs and SOPs. c. Verify use of IRB approved Informed Consent Form. d. Ensure investigator and staff adherence to protocol and initiate action to resolve issues. e. Ensure essential regulatory documents are available and current. f. Review CRFs for completeness and accuracy and ensure that corrections are made appropriately .g. Perform source document verification. h. Perform query resolution procedure if applicable i. Review Adverse Events and/or Serious Adverse Events and follow reporting procedures to Pediatrix Medical Group/Sponsor. j. Track progress of study enrollment and assist in patient recruitment detailing actions and findings. k. Assist in resolving site problems (i.e., enrollment issues).l. Ensure Clinical Trial Material (CTM) accountability. m. Provide Pediatrix Medical Group/Sponsor with monitoring report after each visit. n. Document visit on monitor log in trial manual.

4. In-house M