Clinical Trial Associate

Job Description:

The Clinical Trial Associate will support the Clinical Affairs department in the conduct of clinical research studies (IDE/Post-Approval/Post-Market) sponsored by a medical device start-up. This role involves assembling and distributing clinical study materials, maintaining the Trial Master File, collecting, filing, and tracking regulatory documents, tracking IRB/EC approvals and renewal dates, and managing device accountability and shipments. The position requires strong communication skills, the ability to work independently, and the ability to manage clinical projects in a fast-paced environment.

Responsibilities:

Update and maintain the study Trial Master File (TMF) and keep all study files current.

Manage device accountability activities, including shipping and receiving.

Prepare study materials for site initiation visits and ongoing study conduct.

Support document translations.

Provide support to sites and field monitoring personnel by shipping study supplies and updated binders/forms.

Assist with administrative activities related to Investigator and Coordinator Meeting logistics and materials.

Generate and maintain clinical affairs-related metrics.

Assist in the creation and/or submission of clinical study reports, regulatory submissions, publications, and presentations.

Qualifications and Experience:

Experience supporting a department.

Familiarity with Medical Device product trials and regulations; working knowledge of GCP is a plus.

At least 1 year of experience with Trial Master File support.

Exceptional time management skills; ability to multi-task and prioritize.

Advanced oral and written communication skills.

Ability to work independently and with teammates.

Good problem-solving skills.

Excellent communication and interpersonal skills with the ability to maintain ongoing communications with department staff, clinical study site personnel, and other employees.

Personal attributes: independent, decisive, accurate, detail-oriented, multi-tasking, organized, and flexible.

Latest Jobs

Clinical Operations Associate

Daiichi-Sankyo

Basking Ridge

Ctms Ba (Speak - Japanese Language)

Centraprise

Basking Ridge

Assoc Director Heor

Insmed

Bridgewater

Director Heor

Insmed

Remote, USA

Therapeutic Specialist

Insmed

Baltimore

Associate Director, Medical Science Liaison

Insmed

Jacksonville

Sr. Research Associate

Insmed

Bridgewater

Clinical Research Scientist

Insmed

Remote, USA

Senior Clinical Data Manager

Insmed

Bridgewater

Clinical Document Specialist, Clinical Documentation Management

Rwj Barnabas Health

Livingston

Pharma Jobs in India

Andra Pradesh :

Assam :

Dibrugarh | Diburghar | Guwahati |

Bihar :

Hajipur | Patna |

Chhattisgarh :

Bilaspur | Raipur |

Delhi :

Delhi | PAN-India |

Goa :

Goa | Panaji |

Gujarat :

Haryana :

Himachal Pradesh :

Solan |

Jharkhand :

Ranchi |

Karnataka :

Kerala :

Kochi | Malappuram |

Madhya Pradesh :

Indore |

Maharashtra :

PAN-India :

Panjab :

Punjab :

Rajasthan :

Banasthali | Jaipur | Pilani | Udaipur |

Tamil Nadu :

Uttar Pradesh :

Uttarakhand :

Dehradun | Nainital | Rishikesh |

West Bengal :

Kolkata |

Pharma Jobs in United States

Arizona :

Chandler | Tempe | Tucson |

California :

Colorado :

Denver |

Connecticut :

Storrs |

D.C :

Washington |

Florida :

Coral Gables | Gainesville | Jacksonville | Tallahassee |

Georgia :

Atlanta |

Illinois :

Abbott Park | Champaign | Chicago | Deerfield |

Indiana :

Bloomington | West Lafayette |

Kansas :

Lawrence |

Maryland :

Baltimore | Rockville |

Massachusetts :

Boston | Cambridge | Medford and Somerville | Rockland |

Minnesota :

Minneapolis and St. Paul, Minnesota. |

Missouri :

Fulton | St. Louis |

New Jersey :

New York :

Buffalo | Ithaca | Morningside Heights |

North Caroline :

Chapel Hills | Durham | Morrisville | Raleigh |

Ohio :

Columbus, |

Pennsylvania :

Philadelphia | Pittsburgh |

Tennessee :

Nashville |

Texas :

Austin | Houston |

Virginia :

Blacksburg |

Washington :

Pullman | Seattle |

WI :

Madison | Wausau |

Wisconsin :

Pharma Jobs in Germany

Baden-Wurttemberg :

Bavaria :

Berlin :

Mitte |

Brandenburg :

Berlin |

Hesse :

Marburg |

Hessen :

Frankfurt |

Lower Saxony :

Gottingen | Hannover | Leipzig |

Mecklenburg Vorpommern :

Rostock |

Munich :

Bavaria |

North Rhine Westphalia :

Rhineland Palatinate :

Mainz |

Rotherbaum :

Hamburg |

Saarland :

Saarbrucken |

Saxony Anhalt :

Halle |

Schleswig Holstein :

Kiel |

Pharma Jobs in Australia & England & Europe & Ireland & Remote & Saudi Arabia

New South Wales :

Sydney |

Queensland :

Queensland |

United Kingdom :

London |

Serbia :

Belgrade |

Republic of Ireland :

Limerick | Dublin |

Remote :

Remote - Europe | Remote | Switzerland | Remote, USA |

Makkah :

Najran | Jeddah |

Job Description

Job Title:

Company:

Type:

Location:

Hours:

Compensation:

Employment Terms:

Job Description:

Responsibilities:

Qualifications and Experience:

Additional Qualifications:

Employer-Provided Information:

Latest Jobs

Clinical Operations Associate

Ctms Ba (Speak - Japanese Language)

Assoc Director Heor

Director Heor

Therapeutic Specialist

Associate Director, Medical Science Liaison

Sr. Research Associate

Clinical Research Scientist

Senior Clinical Data Manager

Clinical Document Specialist, Clinical Documentation Management

Pharma Jobs in India

Pharma Jobs in United States

Pharma Jobs in Germany

Pharma Jobs in Australia & England & Europe & Ireland & Remote & Saudi Arabia