Clinical Trial Coordinator (PA) - OSG FSP - Contract/Temporary Opportunity

Submission for the position: Clinical Trial Coordinator (PA) - OSG FSP - Contract/Temporary Opportunity - (Job Number: 168096)

Clinical Trial Coordinator - PPD Outsourcing Solutions Group

*Home-Based/Remote Based Contract/Temp Opportunity

*Full Time (FTE 1.0)

*6 month duration

The PPD flexible staffing program, with our internal PPD Outsourcing Solutions Group (OSG) offers flexible work options where you can be a part of the PPD culture as a contract, temporary worker, consultant worker or freelancer.

*Register today to hear more about open or future opportunities at PPD!*

The Clinical Trial Coordinator will provide technical support to the project team, by coordinating non-clinical responsibilities of project administration as applicable to the client contract under the direction of the assigned Clinical Manager or Sr. Clinical Manager.

Responsibilities will include, but are not limited to; According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix. Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system. Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads. Supports the maintenance of study specific documentation and systems including but not limited to: study team lists, tracking of project specific training requirements, system access management, and tracking of project level activity plans in appropriate system. Provides system support (i.e. GoBalto & eTMF). Supports RBM activities. Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members. Supports scheduling of client and/or internal meetings. Reviews and tracks local regulatory documents. Transmits documents to client and centralized IRB/IEC. Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation. Maintains vendor trackers. Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites. Assists with study-specific translation materials and translation QC upon request.

Clinical Trial Coordinator - PPD Outsourcing Solutions Group

*Home-Based/Remote Based Contract/Temp Opportunity

*Full Time (FTE 1.0)

*6 month duration

The PPD flexible staffing program, with our internal PPD Outsourcing Solutions Group (OSG) offers flexible work options where you can be a part of the PPD culture as a contract, temporary worker, consultant worker or freelancer.

*Register today to hear more about open or future opportunities at PPD!*

The Clinical Trial Coordinator will provide technical support to the project team, by coordinating non-clinical responsibilities of project administration as applicable to the client contract under the direction of the assigned Clinical Manager or Sr. Clinical Manager.

Responsibilities will include, but are not limited to; According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix. Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system. Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads. Supports the maintenance of study specific documentation and systems including but not limited to: study team lists, tracking of project specific training requirements, system access management, and tracking of project level activity plans in appropriate system. Provides system support (i.e. GoBalto & eTMF). Supports RBM activities. Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members. Supports scheduling of client and/or internal meetings. Reviews and tracks local regulatory documents. Transmits documents to client and centralized IRB/IEC. Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation. Maintains vendor trackers. Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites. Assists with study-specific translation materials and translation QC upon request.

Education and Experience: Bachelor's Degree or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities

Knowledge, Skills and Abilities: Ability to work in a team or independently as required Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency Strong customer focus Flexibility to reprioritize workload to meet changing project timelines Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout Good English language and grammar skills and proficient local language skills as needed Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems Ability to successfully complete PPD clinical training program Self-motivated, positive attitude and good interpersonal skills

Working Conditions: Work is performed in an office or clinical environment with exposure to electrical office equipment. Occasional drives to site locations. Potential Occasional travel required.

Physical Demands: Frequently stationary for 4-6 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasional mobility required. Occasional crouching, stooping, bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. May interact with others, relating and gathering sensitive information. Interaction includes diverse groups. Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance.

Education and Experience: Bachelor's Degree or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities

Knowledge, Skills and Abilities: Ability to work in a team or independently as required Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency Strong customer focus Flexibility to reprioritize workload to meet changing project timelines Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout Good English language and grammar skills and proficient local language skills as needed Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems Ability to successfully complete PPD clinical training program Self-motivated, positive attitude and good interpersonal skills

Working Conditions: Work is performed in an office or clinical environment with exposure to electrical office equipment. Occasional drives to site locations. Potential Occasional travel required.

Physical Demands: Frequently stationary for 4-6 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasional mobility required. Occasional crouching, stooping, bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. May interact with others, relating and gathering sensitive information. Interaction includes diverse groups. Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance.

IE-IE-Dublin, FR-FR-France, BG-BG-Sofia, BG-BG-Sofia-FSP Sofia BG Tsarigradsko Shos, IE-IE-Dublin-FSP DUBLIN IE Rathfarnham, GB-GB-Winchester, BG-BG-Sofia-Sofia 115G Tsarigradsko Shosse, United Kingdom, GB-GB-Middlesex-FSP Uxbridge UK Stockley Prk W, ES-ES-Madrid-Madrid ES - Titan, 15, France, GB-United Kingdom, FR-France, IE-Ireland, FR-FR-Ivry-sur-Seine Ced-Ivry-sur-Seine Cedex FR PVC, GB-GB-Middlesex, BG-Bulgaria, IE-IE-Athlone-Athlone IE Business & Tech Pk, BE-BE-Brussels-Brussels BE St Stevens Woluwe, GB-GB-Stevenage-FSP Stevenage UK, IE-IE-Athlone, Spain, IT-Italy, GB-GB-Stevenage, GB-GB-Winchester-Winchester GB 1-2 Crown Walk, FR-FR-France-FSP MarlyleRoi FR Versaille Rd, GB-GB-Bellshill-Bellshill GB Fleming House 1, GB-GB-Bellshill, Italy, BE-BE-Brussels, Belgium, DE-Germany, IT-IT-VERONA-FSP VERONA IT FSP Fleming, DE-DE-Munich-FSP Munich DE Prince Regent Sq, DE-DE-Nuremberg, ES-ES-Madrid-FSP Madrid ES Plaza de Carlos, BE-Belgium, DE-DE-Munich, DE-DE-Karlsruhe, Germany, ES-Spain, IT-IT-VERONA, IT-IT-Segrate (MI), DE-DE-Karlsruhe-Karlsruhe DE, IT-IT-Segrate (MI)-Milano IT Via San Bovio, ES-ES-Madrid, DE-DE-Munich-Munchen DE Hansastrasse, BE-BE-Rixensart-Rixensart FSP, BE-BE-Wavre-FSP Wavre BG Avenue Pascal, Bulgaria, Ireland, FR-FR-Ivry-sur-Seine Ced, BE-BE-Rixensart, BE-BE-Wavre, BE-BE-Zaventem, DE-DE-Nuremberg-Nuremberg DE Sulzbacher Str.48, GB-GB-Cambridge-Cambridge GB Granta Park1, GB-GB-CambridgeIE-IE-Dublin, FR-FR-France, BG-BG-Sofia, BG-BG-Sofia-FSP Sofia BG Tsarigradsko Shos, IE-IE-Dublin-FSP DUBLIN IE Rathfarnham, GB-GB-Winchester, BG-BG-Sofia-Sofia 115G Tsarigradsko Shosse, United Kingdom, GB-GB-Middlesex-FSP Uxbridge UK Stockley Prk W, ES-ES-Madrid-Madrid ES - Titan, 15, France, GB-United Kingdom, FR-France, IE-Ireland, FR-FR-Ivry-sur-Seine Ced-Ivry-sur-Seine Cedex FR PVC, GB-GB-Middlesex, BG-Bulgaria, IE-IE-Athlone-Athlone IE Business & Tech Pk, BE-BE-Brussels-Brussels BE St Stevens Woluwe, GB-GB-Stevenage-FSP Stevenage UK, IE-IE-Athlone, Spain, IT-Italy, GB-GB-Stevenage, GB-GB-Winchester-Winchester GB 1-2 Crown Walk, FR-FR-France-FSP MarlyleRoi FR Versaille Rd, GB-GB-Bellshill-Bellshill GB Fleming House 1, GB-GB-Bellshill, Italy, BE-BE-Brussels, Belgium, DE-Germany, IT-IT-VERONA-FSP VERONA IT FSP Fleming, DE-DE-Munich-FSP Munich DE Prince Regent Sq, DE-DE-Nuremberg, ES-ES-Madrid-FSP Madrid ES Plaza de Carlos, BE-Belgium, DE-DE-Munich, DE-DE-Karlsruhe, Germany, ES-Spain, IT-IT-VERONA, IT-IT-Segrate (MI), DE-DE-Karlsruhe-Karlsruhe DE, IT-IT-Segrate (MI)-Milano IT Via San Bovio, ES-ES-Madrid, DE-DE-Munich-Munchen DE Hansastrasse, BE-BE-Rixensart-Rixensart FSP, BE-BE-Wavre-FSP Wavre BG Avenue Pascal, Bulgaria, Ireland, FR-FR-Ivry-sur-Seine Ced, BE-BE-Rixensart, BE-BE-Wavre, BE-BE-Zaventem, DE-DE-Nuremberg-Nuremberg DE Sulzbacher Str.48, GB-GB-Cambridge-Cambridge GB Granta Park1, GB-GB-CambridgeSubmission for the position: Clinical Trial Coordinator (PA) - OSG FSP - Contract/Temporary Opportunity - (Job Number: 168096)