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Collegeville, PA, United StatesPosted 135 months ago
ContractonsiteMid-Senior Level

Job Description

• Responsible for working collaboratively with the Lead Study Clinician, Clinical Operations Study Team Lead (COSTL), and other members of the Study Team (e.g. Alliance Partner/ CRO ,Regulatory Affairs, Legal, Pharm Sci, Contracts and Outsourcing) to implement one or more clinical protocols, with focus on study start-up and recruitment phases. 

• Will be an integral study team member and key member of study feasibility team to identify, evaluate and select clinical sites and investigators. 

• May be responsible for developing a site back-up plan that can be executed to support agreed timelines for study completion. 

• Primary focus will be site communication to ensure site is knowledgeable on protocol requirements, recruitment and retention planning, solution and relationship building during the study start-up phase to optimize completion time for the clinical trial start-up phase and ensure site is ready to screen subjects immediately after initiation occurs. Work closely with sites to proactively identify, manage and timely resolve study start-up up challenges, bottlenecks, site concerns. 

• Mid-level - Prefer ~5+ years ‘experience in clinical trial execution .

• Must have thorough understanding local and international regulations applicable to clinical trials. 

• The candidate experience should not solely be operational but rather have experience in alignment with our current Clinician position roles and responsibilities .

• The candidate must have EXCELLENT communication skills and be thoroughly comfortable in speaking with prospective PIs and Study Coordinators. 

• Must be proficient in collaborative problem-solving skills (A prior CRA or someone with Study Coordinator experience would be a good fit for this position.)

• BA/BS or Higher Degree preferred (M.S/PhD/PharmD/MD)

• 4-7 years of experience in Good Clinical Practices (GCP)

• 4-7 years of experience in Clinical Trials Safety Reporting

Contact-

Ricky Bansal

732-429-1925

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Study Clinician at Integrated Resources INC | Renata