Clinical Development Specialist -Medical Affairs (Remote)

Job Description

A Clinical Development Specialist will work with Quest Medical and Laboratory Directors and their staff, Clinical Development management and staff, external scientific and clinical administrative staff and external vendors to support S & I clinical development research efforts. The Clinical Development Specialist is responsible for oversight of all operational aspects of clinical studies including; clinical study initiation activities, site selection and training efforts, study documentation, study site monitoring, query resolution, data monitoring and data flow, flow of specimens between sites, study site payment activities, study close down. This person will report to Clinical Development Management.

This professional can work in a remote capacity and must be located in the US. 

Responsibilities:

• Develop study initiation and management plans with Clinical Development Management and Principal Investigators (both internal and external).

• Assist with assessing site/investigator interest and feasibility, site selection, initiation/training, provisioning of study materials to study sites, site monitoring and resolution of study-related problems. 

• Track study progress, adherence to protocol, data submission, deviations and discrepancies.

• Communicate with sites on a regular basis, send updates on current status of study enrollment and follow study-related queries until resolved.

• Work with Biorepository staff to ensure efficient and accurate study sample management and relay information on sample transfer to/from analysis lab personnel.

• Provide sample handling expertise and guidance during project design and operation.

• Build, populate and maintain study document folders.

• Proactively look for and communicate potential program risks to Clinical Development Management/PI and provide possible mitigation strategies.

• Work with data management to design Case Report Forms (CRFs) and resolve data discrepancies.

• Work as a research services manager for select sites and external vendors.  Monitors routing and status of contracts and agreements.

• Assist in subject recruitment and conduct informed consenting as needed.

• Collaborate and coordinate activities with other Coordinators to ensure continuity of study management.

• Collaborate effectively with all internal and external Clinical Development partners and customers.

• Coordinate payments to study sites and vendors and subject reimbursements.

• Perform remote or on-site monitoring visits.

• Assist with and oversee efforts provided by third party vendors such as CROs.

• Co-manage a study status database with other Coordinators.

• Assess resource demands and report needs to Clinical Development Management to assure timely achievement of program deliverables. 

• Coordinate deidentification of Quest samples and transportation to external collaborators. 

• Perform other duties as assigned.

  
  

Qualifications:

Bachelor’s Degree preferably in health, life sciences with three or more years experience working in the capacity of a clinical research study coordinator or a minimum of five years of clinical research experience or five years’ experience in a similar capacity. 

Working knowledge of Good Clinical Practices (GCP’s) and International Conference on Harmonization (ICH) guidelines and/or Clinical Laboratory Improvement Amendments (CLIA).Have or complete current CITI training for Human Subjects Research.

• Demonstrate effective written and verbal communication skills.

• Ability to set priorities and address high priority tasks as appropriate.

• Demonstrate strong problem-solving skills, adapt current job skills and learn novel approaches to solve problems 

• Able to drive innovation by embracing diversity and change.

• Possess outstanding organizational skills and the ability to work on multiple projects at one time.

• Proficient in the use of Microsoft Office.

• Possess a fundamental knowledge of clinical and scientific research.

Travel: Up to 20%

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