clinical study sites

clinical study sites
Description of function of CSM:
Overall responsibility for all aspects of the management of multiple clinical study sites conducting clinical research using developmental the client products. Site management responsibilities include site recruitment, selection, training, contract and investigator budget development, monitoring, conflict resolution, patient enrolment, and finalization of site activities. All monitoring activities will be conducted to ensure compliance with GCP ICH Guidelines and all applicable State, Federal and country specific requirements.
Direct Sales Responsibility: Since monitoring, per the Code of Federal Regulations in the U.S. and ICH GCP guidelines, serves the regulatory function of ensuring the quality, validity and integrity of clinical trial data, the impact of performance can be large. Specifically, the impact can be expressed in terms of regulatory risk and the fact that the data directly leads to new products, additional labelling and broader use of existing products, and information that supports the continued sales and marketing of company products. Additionally, many of the investigator’s performing clinical trials at sites the CSM will be managing are important opinion leaders and prescribe our medications.
Budget: The CSM will often have the responsibility of assisting and negotiating investigator contract payment terms and budget resolution and determining payments due sites based on agreed budgets.
Geography: Regional
Other: Careful and accurate monitoring ensures that a clinical trial is being performed according to the protocol and local regulations, which has a major impact on the reliability and credibility of the results and the company’s image and goodwill.
• Manage the identification, evaluation and selection of clinical investigators to ensure that the investigators have adequate qualifications and resources to safely and properly conduct the clinical trial and that this remains adequate throughout the trial period
• Provide necessary training to ensure that the investigator and the clinical site staff are appropriately trained and adequately informed about the clinical trials
• Obtain from the clinical site the necessary documents in order to prepare the Investigator Site File and assure all ICH Essential Documents are available in order to gain “regulatory release”
• Verify that the rights and well-being of human subjects are protected and that the investigator enrols eligible subjects
• Assist in the review, approval and finalization of the Data Management Plan, CRFs, and edit specifications
• Verify that the trial is conducted in accordance with GCP ICH guidelines, the protocol, and all applicable SOPs, laws and regulatory requirements (i.e., ICH guidelines and/or local regulations)
• Ensure the quality and integrity of the reported trial data by verifying the accuracy, completeness and consistency of the data in the CRF and source documents based on the established source data verification plan and frequency of monitoring visits
• Act as the main line of communication between the sponsor and the investigators and take the lead in conflict resolution
• Prepare monitoring reports and follow-up on significant deviations from the protocol, SOPs, GCP and applicable regulatory requirements with the investigator and study team
• Obtain information from the site to update (IMPACT) and track and analyze site trends to implement corrective actions and evaluate investigator performance
• Assist in the implementation of site recruitment strategies to ensure overall project recruit goals are attainable
• Complete study feasibility information for the centers that are managed
• Negotiate site budgets and assist in contract terms and administer site payments due to the investigator based on agreed budgets
• Participate in the in-house data review and cleaning, including query resolution and data listings review and participate in the pre-analysis review meeting
• Prepare, conduct and report trial site close-out activities
• Rectify audit issues identified at investigator sites\
• Develop territory to identify and develop new relationships with preferred research centers.
• Contribute region specific knowledge and share learning with other team members.

Demba Sidibe| Stamford Consultants
Professional Recruitment
Tel: +41 61 560 77 28
[Email hidden]
Friedensgasse 10, 4143 Dornach (SO)

www.stamford-consultants.com