Scope:  The Clinical Operations Coordinator (COC) is involved in the conduct of the study and interfaces with the Study Manager and the Study Team.  They support the Study Team by creating and distributing study team materials, tools and documents.

Responsibilities will include, but are not limited to, the following:

1.     Support the Study Team to identify potential investigators and assess their interest in the study

2.     Communicate with the sites through direct contact and other tools such as newsletters

3.     Track study progress in CTMS including patient enrollment and patient dispensation

4.     Process drug shipments after gathering necessary essential documents and track the receipt of

     shipments

5.     Support study data as the EDC administrator and by tracking CRFs and queries

6.     Process and track payments to vendors and study sites

7.     Have a significant role in managing the study documentation including responsibility for:

•          Distribute and, at times, create study documents for the study sites including protocols, CDAs, feasibility questionnaires, study binders, etc.

•          Review documents including essential documents and submit documents to appropriate departments such as IMSC, Regulatory Affairs, etc.

•          Maintain and track documents including the IB, documents that are expiring and IND safety letters using CTMS (or other tools)

•          Transmit the necessary documents to the TMF

•          Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings with CROs and other vendors

•          Generate, finalize and distribute study team agendas and meeting minutes

•          Assist with generating the CSR appendices and participate in SOP and WP development

•          Mentor and coach other COCs, as appropriate, and participate or provide leadership in Departmental initiatives

Skills/Knowledge Required:

§        Computer skills - MS office suite

§        CTMS (TW, Celtrak)

§        Knowledge of databases

§        Efficient at meeting planning / generating minutes

§        Understanding / familiarity with drug development and process and Pharma

§        Strong Verbal and written communications skills

§        Self starter / proactive

§        Good listener / problem solver

§        Ability to prioritize and multi-task and demonstrate flexibility and attention to detail

§        Familiarity with ICH / GCP and regulatory guidelines

§        Team player and ability to build relationships

§        Strong organizational skills

§        Proficient at Vendor / site payment process

Key (PDI) Competencies:

§         Works efficiently

§         Works independently

§         Demonstrate adaptability and flexibility

§         Prepares written communication

§         Drives for results

§         Acts with integrity

§         Develops oneself

§         Commitment to quality

§         Uses technical / functional expertise

§         Listens to others

§         Proactive behavior