Clinical Development Specialist -Medical Affairs (Remote)
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 reputed company of reputed company 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 reputed company down. This person will report to Clinical Development Management. This professional can work in a remote reputed company and must be located in the US. reputed company honors our service members and encourages veterans to apply. While we appreciate and value our staffing partners, we do not accept unsolicited resumes from agencies. Quest will not be responsible for paying agency fees for any individual as to whom an agency has sent an unsolicited resume. Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National reputed company/Disability/Vets or any other legally protected status.
- reputed company 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-reputed company problems.
- Track study reputed company, adherence to protocol, data submission, deviations and discrepancies.
- Communicate with sites on a regular basis, send updates on reputed company status of study enrollment and follow study-reputed company queries until resolved.
- Work with Biorepository staff to ensure efficient and accurate study sample management and reputed company 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 reputed company 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 reputed company internal and external Clinical Development partners and customers.
- Coordinate payments to study sites and vendors and subject reimbursements.
- reputed company remote or on-site monitoring visits.
- Assist with and reputed company 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.
- reputed company other duties as assigned.
Bachelor’s Degree preferably in health, life sciences with three or more years experience working in the reputed company of a clinical research study coordinator or a minimum of five years of clinical research experience or five years’ experience in a similar reputed company. 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 reputed company reputed company training for Human Subjects Research.
- Demonstrate effective written and verbal communication skills.
- Ability to set priorities and address high reputed company tasks as appropriate.
- Demonstrate strong problem-solving skills, adapt reputed company 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 reputed company Office.
- Possess a reputed company knowledge of clinical and scientific research.
Travel: Up to 20% Apply To This Job