"Clinical Research Coordinator B"

Job Description Summary

This position's primary function is to facilitate, promote, and ensure good clinical practice in the conduct of all research protocols at the Neurology PAH Parkinson's Disease and Movement Disorders Center. The coordinator will independently manage different phases of complex clinical trials. They will coordinate the screening of patients, subject enrollment, collection and storage of biological samples, updates and maintenance of regulatory documents, and collection and management of clinical data. They will work with the IRB as well as other internal and external partners to ensure that all study documentation is submitted appropriately for initial approval and continuing maintenance.

Job Description

This position will function as lead coordinator on several complex phase I-IV studies. They will coordinate protocol compliance, enrollment and retention of subjects, management of subject visits, management of study drug or devices, and regulatory submissions. This includes recruitment, consent, and screening of patients into the protocol, scheduling subject visits, monitoring and ensuring adherence to protocol requirements, and subject training. They will maintain organized study documentation including source documents, case report forms, subject binders, regulatory binders, and electronic data entry. They will be responsible for collecting, reviewing, and reporting study data, completing data entry, and resolving queries. They will manage all aspects of subject visits including subject training and retention, completion of assessments and questionnaires (PROs), and collection, processing, and shipping of laboratory samples. Assessments may include ECG/EKGs, vital sign collection, cognitive testing, training subjects on study devices or programs, review of medications and medical history, review and reporting of adverse events, etc.

This position will participate in study start up, ongoing study maintenance, monitoring, audits, and close out visits. They will attend study team meetings and ongoing protocol training or compliance meetings. They will develop and maintain study specific source documents, regulatory submissions, and regulatory documents/binders. They will review internal budgets, complete research billing, invoice the sponsor, and set up subject payments per budget.

Qualifications

• Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.
• Excellent verbal/written communication skills required
• Able to work collaboratively on all levels and to gain support of others
• Able to confidently interact with all levels of management including senior management, physician leaders and others
• Demonstrated complex problem solving abilities
• Strong innovative skills
• Excellent interpersonal and multi-tasking skills
• Must be flexible, detail oriented, and organized
• Demonstrated ability to work as part of a team, as well as independently with minimal supervision
• Thorough knowledge relevant regulations for the conduct of clinical trials including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) Guidelines. Knowledge of funding policies, NIH, and other grant procedures is desired.

This position is contingent upon grant funding.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$52,500.00 - $53,000.00 Annual Rate

Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.