Job Description

Job Title: Study Support Coordinator

Department: Study Support

Location: Mumbai, India

Hours Per Week: 40 hours

Schedule: Days, Monday – Friday

As a member of our Clinical Trials Study Management Team, the Study Support Coordinator will support Project Managers, Clinical Trial Administrator’s, Clinical Trial Research Associates, Project Set-up Coordinators and Logistics from study set up through study close out. Acts as a member of the Study Management Team to support all ongoing studies with tasks as needed, as defined by the Study Management Team or ACM client. Guaranteeing client satisfaction by providing exceptional service through a consistent customer centric approach, focus on precision delivery and flexibility to meet customer expectations.

RESPONSIBILITIES

• Participates in Clinical Trial Study Management meetings and task forces.

• Maintain positive working relationships with Clinical Trials Study Management Team and key stakeholders.

• Manage LIMS data entry including but not limited to: results, registration of samples into LIMS and perform QC.

• Tracking of reference laboratory/3PL results and entry into LIMS according to the agreed time frames.

• Ensure that appropriate laboratory staff are informed of received reference laboratory/3PL results, so that they can authorize the results in a timely manner.

• Filing of reference laboratory results.

• Support execution of study specific validations and work with Project Managers, Clinical Trial Administrator’s / Site Management Administrator’s and Study Setup Coordinators to ensure pass of all test cases.

• Support Clinical Trial Research Associates in their day to day work flows related but not limited to data queries and data cleaning.

• Provide support to the Study Management team as needed.

• Participate in training to maintain relevant working knowledge of Clinical Trials.

• Participates and documents Quality Audits and inspections of Clinical Trials as prescribed by departmental policies and regulatory agencies.

• Performs duties with a general working knowledge of Regional Regulatory bodies, GCP, GDP, ICH and other pertinent regulations, as pertains to central laboratory functions.

• Actively assist the department director/head and reporting manager in the smooth functioning of the office.

• Ensure that the Team is kept motivated and aligned to the business objective of the organization.

• Understands and follows company policies and procedures while always maintaining confidentiality, both inside and outside of the work place.

• Maintain financial performance of company by executing on job duties as specified and by proactively and continuously bringing to management’s attention ideas to improve productivity, service, quality, cost savings, process improvements, policies & procedures, and utilization of company resources.

• Improve job knowledge by in-house, outside work, self-study, and on-line training in addition to industry functions, certifications, publications, and other available training resources.

• Perform other duties as assigned.

REQUIRED QUALIFICATIONS

• Graduate degree in the fields of Bio-chemistry, Microbiology, Chemistry, Bio-technology or scientific concentration required.

REQUIRED QUALIFICATIONS

• Master’s degree in the fields of Bio-chemistry, Microbiology, Chemistry, Bio-technology or scientific concentration preferred.

• Preferred 1 year direct health care experience, central laboratory experience.

• Excellent verbal and written communication skills.

• Computer proficiency required; familiarity with relational databases and reporting tool strongly preferred.

• Ability to multi-task and prioritize workload preferred.

• Customer Service experience preferred.

• Critical thinking and ability to problem-solve.

PHYSICAL REQUIREMENTS:

S - Sedentary Work - Exerting up to 10 pounds of force occasionally Sedentary work involves sitting most of the time, but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.